4/26/2016

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Low Back Pain Update

Practical Advances in Internal Medicine Symposium 2016

Richard Wernick, M.D.

4/26/2016

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Low Back Pain 2008: Summary

1) Specifically treatable etiologies are uncommonre acute LBP.

Low Back Pain 2008: Summary

1) Specifically treatable etiologies are uncommon re acute LBP.

2) Most acute pts do okay with benign neglect.

4/26/2016

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Low Back Pain 2008: Summary

1) Specifically treatable etiologies are uncommonre acute LBP.

2) Most acute pts do okay with benign neglect.3) There is no consensus on the most effective

Rx approach (chronic).

Low Back Pain 2008: Summary

1) Specifically treatable etiologies are uncommonre acute LBP.

2) Most acute pts do okay with benign neglect.3) There is no consensus on the most effective

Rx approach (chronic).4) Current practice is NOT based on evidence.

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Low Back Pain 2008: Summary

5) All of these Rx’s are disproven or unproven:- rest, exercise (acute), TCNS, corset,

education/advice, acupuncture, massage, manipulation, injections, fusions

Low Back Pain 2008: Summary

5) All of these Rx’s are disproven or unproven:- rest, exercise (acute), TCNS, corset,

education/advice, acupuncture, massage, manipulation, injections, fusions

6) Exercise is of modest benefit for chronic LBP.

4/26/2016

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Low Back Pain 2008: Summary

5) All of these Rx’s are disproven or unproven:- rest, exercise (acute), TCNS, corset,

education/advice, acupuncture, massage, manipulation

- injections, fusions6) Exercise is of modest benefit for chronic LBP.7) Sham acupuncture helps.

Low Back Pain 2016: Summary1) Specifically treatable etiologies are uncommon

re acute LBP.2) Most acute pts do okay with benign neglect.3) There is no consensus on the most effective

Rx approach (chronic).4) Current practice is NOT based on evidence.5) All of these Rx’s are disproven or unproven:

- rest, exercise (acute), TCNS, corset, education/advice, acupuncture, massage, manipulation, injections, fusions

6) Exercise is of modest benefit for chronic LBP.7) Sham acupuncture helps.

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Low Back Pain Update 2016: Outline

• Scope of the problem• Imaging/red flags• Back vs. leg ± back (sciatica)

Acute vs. chronic LBP• Rx update• Lumbar spinal stenosis• Choosing wisely

Low Back Pain: Scope of the Problem

• 80% at some point, 50%/yr, recurs in 90%• 1-2% sciatica• #1 cause of disability >45 y/o• $100-200 billion total cost (2009)• 65% cost ’97 ‘05

– Yet % pts with f’n from 20 24%

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The Low Back Pain Patient:Initial Questions

• Back and/or leg pain?• Serious (& treatable) systemic disease?• Neuro compromise requiring surgery?• Imaging today?• Rx?

Low Back Pain in Primary Care:Prior Probabilities

• Compression Fx ~ 1/50• Malignancy ≤ 1/200 (BLT/KP+M)• Spondylitis ? 1/350• ID ~ 1/10K !• “Nonspecific BP” ± degenerative arthritis > 90%

• If sciatica: HNP, facet jt OArare ID, tumor

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LBP: Red Flags for Imaging Now(AP & Lateral)

• Ca – prior Ca (“some evidence”, Cochrane ‘13)• Fx - >70 y/o, steroids, “sig trauma”

– “weak rec”, high FP rates (Cochrane ‘13)– Very wide CIs around LRs

• Spondylitis - <40 y/o, insidious, 3 mos, AM/rest

• Nonspecificity!

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LBP: Red Flags for Imaging Now (2)(AP & Lateral)

• 1 yr outcome of >65 y/o’s with early (<6 wks) imaging no better– “regardless of age, early imaging should not

be performed routinely” (Jarvik ‘15)• Persistence at 6 wks ??• Major neuro deficits – straight to MRI

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The Herniated Nucleus Pulposus (HNP)

• Sciatica ± LBP• 98% L5 or S1 roots• MRI ?

– Are both you and the patient ready to go to surgery now?

– Beware low specificity of “abnormalities”!• DDD 90% >60 y/o, disk bulge

50%/protrusion 29% . . .

“Nonspecific” Low Back Pain

• “Chronic pain syndrome” ?• Pain by 60% at 1 month, continued to 3 mos

– Recurrence in ¼ within 3 mo, ¾ in 1 yr (Pengel‘03 meta)

• Median 58 days for pain resolution– Only 72% completely recovered at 12 mos

(Henschke ‘08)– Of pts with ≥12 wks pain, 1/3 ok 9 mos later– Unpredictable course (Rat’l Clin Exam’10, LRs ≤3)

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Lumbar Spinal Stenosis (LSS)

• Narrowing of spinal or nerve root canal• Pseudoclaudication in 60-90%, gradually progressive• Rat’l Clin Exam ‘10 – leg pain 2/2 to LSS ?

– No pain seated LR = 7.4– Sx bending = 6.4– Bilateral butt or leg pain = 6.3– Pseudoclaudication = 3.7

• MRI if surgical candidate– Beware >20% FP rate if >60 y/o

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Efficacy of paracetamol for acute low-back pain: A double-blind, RCT. Williams et al, Lancet 2014;384:1586-96

• n=1653 with <6 wks LBP, 235 primary care centers in Australia; 1st RCT vs placebo !

• Up to 4 wks acet 1330 mg t.i.d. vs. prn vs. placebo

• Median time to recovery 17, 17 & 16 days• No effect on pain, function• “Findings question universal endorsement of

paracet in this patient group”

Early physical therapy vs. usual care in patients with recent onset LBP: A RCT.Fritz et al, JAMA 2015;314:1459-1467.

• n=220 w/LBP <16 days• 4 PT sessions (over 3 wks) vs “usual care”; all

educated• No benefit for pain at 4 wks, 3mos, 1 yr• Modest benefit for disability

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Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute LBP: A RCT. Friedman et al, JAMA 2015;314:1572-1580

• n=323, “functionally impairing BP”, 48-72 hrs pain, <65 y/o

• Nap 500 mg b.i.d. for all x 1 wk– Added placebo vs cyclo 5 mg vs oxy 5/acet 325,

1-2 q8 prn• No differences in f’n or pain• At 3 mo, ~ ¼ moderate or severe pain, use of

meds• Conclusion: combo not better than mono Rx• Would regular dosing have worked better?• Inter-individual differences?

Acute Low Back Pain: Rx

• Time and analgesics, normal activity• Not:

– Rest– Exercise– PT– Injections– Surgery

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Chronic Low Back Pain: Rx Update

• Spinal manipulation?– Cochrane 2011: 26 RCTs (9 w/low risk of bias), n=6070

• “High quality evidence of small, not clinically relevant short-term effect on pain relief & f/’n compared to other interventions” (Chr LBP)

– Bromfort ‘14 RCT – n=192, sciatica• ES=0.6 for added manip (≤ 20) at 12 wks vs.

exercise/advice alone• No significant benefit at 52 wks

• Massage ?– Cochrane 2015: 25 RCTs, n=3096

• “Low-very low” quality evidence• “We have very little confidence that massage is

effective”.

Chronic Low Back Pain: Opioids !

• Cochrane 2013• 15 RCTs, n=5540• Tramadol in 5 RCTs: Pain SMD = -0.55, “low quality

evidence”• “Strong opioids” (morph, oxy,. . . .) in 6 RCTs

– Pain SMD = -0.43, “moderate quality evidence”• Trials short duration• Small ES for function• No placebo-RCTs of long-term opioid for chronic LBP

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Effect of mindfulness-based stress reduction vs. cognitive behavioral therapy or usual care on back pain and functional limitations in adults with CHRONIC LBP: A RCT. Cherkin et al, JAMA 2016;315:1240-1249.

• n=342 LBP ≥ 3 mo; mean age 49• 8 weekly 2 hr group sessions• At 26 wks, f’n in 61% mindfulness med/yoga

58% CBT44% usual care

• BP in 44%, 45%, & 27%• Morone ’16: pain at 8 wks and 6 mo

Back Pain: Prevention?

• Education (Daltroy, NEJM ’97)– 4K postal workers, RCT of back school– 2%/yr LB injury, RR 1.1 if schooled– 3 x higher cost– “Failure to change behavior”

• Exercise– ? Mildly protective

• Corsets – failed– RCT cargo workers – no BP rate, sick leave (Van

Poppel’98)• USPSTF ’04 – insufficient evidence in primary care

settings• ’08 review – no evidence to support advice or training

(lifting)• Steffens meta ‘16: minimal quality data!

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Steroids for LBP: Update

• Pred 60 mg taper over 15 days for HNP acute sciatica (Goldberg ‘15)– RCT, n=269, 2 x blind– Modest benefit, no in surgery rate at 52 wks– 2011 meta: surg & tox (Roncoroni ‘11)

• Epidural steroids– Definitive 2012 meta, 23 trials, sciatica: small

short-term (only) benefit for leg pain and disability (Pinto ’12)

– 2015 meta: similar (Chou ‘15)– No benefit for LBP, LSS (Chou ‘15, Friedly ‘14)

Chronic Low Back Pain: Rx

• Some type of exercise/PT• Analgesics (?)• Sham acupuncture ? (do something!)• Mindfulness training or CBT?• Not: massage, steroids, injections, surgery• Inter-individual differences/room for empiricism?

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Rx for Sciatica(Sans Major Neuro Abnormality)

• Time• Analgesics• Surgery for ?10% (>6, >12 wks?)

– Post-op MRI does not correlate with sx(el Darzouhi ‘13)

• LSS: surgeryPT? (Delitto ‘15)

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Back Pain Treatment: PT? –Placebo Beats Doing Nothing*

Control Rx Rx better Rx = control(# studies)

None 15 1(p=0.001)

Placebo 7 15

• What is the optimum “dose” (& cost) of care?• Patient’s expectations affect outcome

*Feine ‘97

LOW BACK PAIN UPDATE Practical Advances in Internal Medicine Symposium 2016

Richard Wernick, M.D.

Scope - 80% of population at some time, 50% Americans each year; 26% in past 3

months (lasting a whole day); 14% will have > 2 wk attack; recurs in 90% (20-45% in 1st yr), 1-2% sciatica

- 4th most common reason for MD office visit – 2.3% of all visits in 2002 - >5 million Americans disabled; rate of claims 14 x from ’65-‘95

- Disability risk inc w/inc duration of current disability, hx previous disability, psychosocial factors, job requirements and dissatisfaction, retention of lawyer (in litigation – free Lithuania, frequency of chronic neck pain post-MVA no higher than in controls – Lancet 317:1207, 1996) – same factors predict failure of Rx

- 1/3 of workers comp $ - $25 billion/yr US direct medical costs, another $50 billion on lost productivity and

disability payments (Cherkin’03) - 65% in healthcare expenditures from ’97-’05; yet % of back pain pts with

f’n/limits from 20 24% - we must be doing something wrong! (Martin ’08) - #2 cause of disability as of 2009, $100-200 billion total costs

Clinical Diagnosis A. Initial questions:

1) Serious systemic (& treatable) disease? 2) Neurologic compromise requiring surgery? 3) Imaging necessary? 4) Treatment?

B. Specifically treatable etiologies & likelihoods (derived from primary care setting)

Compression fracture 1/25 probability in 90’s; post 2010 data- 1/50 Malignancy 1/150 probability in 90’s; post 2010 data ≤1/200 Ankylosing spondylitis 1/350 Infection 1/10,000!! AAA, PUD, idio retroper fibrosis very rare

If sciatica (leg discomfort > back & below the knee), DDx very different Herniated disk (HNP) very common(? 85% probability) Facet jt OA common Tumor, infection rare Thick back pocket wallets rare - note that sciatica can be rarely caused by extraspinal disturbances of sciatic nerve (lower pelvis, butt, gluteal fold, proximal biceps femoris muscle) - posterior leg if S1, dorsolateral L5, anterolat if L4 compression

- 4s -

- >90% of LBP cases will be “nonspecific” , i.e., idiopathic (though pain in some may be from degenerative arthritis)

- Australian inception cohort study, acute LBP – only 0.9% (n=11) “serious” pathology – 8/11 were Fx’s, 0 Ca, 0 ID

- + LRs for Fx – steroids 48, sig trauma 10, age >70 = 11 (Henschke ’09)

For LBP, red flags for a specifically treatable etiology: - Hx of Ca that goes to bone, age >70, fever/infection, prednisone, severe trauma

1. Malignancy Hx Feature Sensitivity

(%) False-

Positive Rate (%)

+ Likelihood ratio (LR)

Hx of Ca No better at 1 mo Age >50 Unexplained wt loss >1 mo No relief w/bedrest

31 31 77 15 50

>90

2 10 29 6

19 54

15 3

2.5 2.5 2.5 2

*Deyo et al. J Gen Intern Med 1988;3:230. Based on approx 2000 BP pts So for eg, If Ca hx, post-test odds=pre-test odds (1/199) x 15 = 15/199

- Cochrane 2013 – cohort studies in primary care – prevalence 0- 0.66%, “some evidence” for Ca hx as a red flag (Henschke ’13)

- Epidural mets/cord compression - 1st manifestation of cancer in 1/5 of cases (of epidural mets),

esp lung, myeloma - T spine in 70% cases - Delay in Dx can lead to paralysis - Xr insensitive, scan nonspecific; MR for Dx

- Cauda equina syndrome (CES) - Caused by mets, massive disc, hematoma, abscess - Urinary retention in 90% (5% of other back pain pts) - >80% have sciatica, neuro deficits (“saddle” anesthesia

75%) - On PE, check breast, lung, prostate, testes (young

male)(retroperitoneal mets causing back pain) if Ca suspected - Other primaries – lymphoma, melanoma, renal, sarcoma,

myeloma - Malignancies & bone

- “B L T with Mayo & a Kosher Pickle” (Breast, Lung, Thyroid, Myeloma, Kidney, Prostate)

2. Infection - Primary site found in only 40%

- 4t -

- Fever in only 50% bacterial osteo (S. aureus > E. coli; 1/4 → wkness, ↑ ESR/CRP 99%), 25% Tb, 50% epidural abscess vs 2% mech LBP (coincidental) - Presence thus increases osteo odds by 25-fold

(positive likelihood ratio = TP = 50%/2% = 25; FP post-test odds = pretest odds x LR), or from 1/10K to 25/10K, still very unlikely

- Percussion tenderness nonspecific – 86% vs 40% mechanical 3. Fracture

Hx Feature Sensitivity

(%) FP rate

(%) +LR

Corticosteroid Age >70 Age >50 Trauma

6 22 84 30

0.5 4

39 15

12 5 2 2

So for eg, If >70 y/o, post-test odds = pre-test odds (1/49) x 5 = 5/49 - Cochrane 2013 – only 4 studies of red flags in primary care, moderate risk of bias; prevalence 0.7-4.5%; LR for sig trauma 3.4- 12.8, older age 3.7-9.4, steroid use 4.0-48.5 (Williams ’13) - Prospective cohort study, 7K white F, mean age 71, approx 15% on

estrogen, lat sp xr baseline and 3.7 yrs later (Nevitt ’98) - New (incident) fx in 5%; 14% if fx at baseline, 3% if not - If new fx, 10 extra limited activity days per year

- even if fx did not come to medical attn (2/3 did not) - odds ratio = 2.6 for back disability

- At 15 yrs, 18% had incident Fx (radiographic) - 41% with prevalent Fx, 14% if not - supports rec that older women with a vert fx should be

treated for osteoporosis irrespective of BMD - Osteoporosis identification and Rx in those at high risk for fx

(certainly those w/previous fx) may prevent chronic LBP and disability - 3 yr RCT, n=2K postmen women w/vert fx & femur bone

density; alendronate 5 mg per day x 2 yr then 10 mg x 1 yr – 3 fewer days of bedrest, 11 fewer limited activity days (cost-effective?) (Nevitt ’00)

- Vertebroplasty (or kyphoplasty)? – NO! No better than sham in 2 well-done RCTs (Staples ’11).

4. Spondyloarthritis - H&P not validated, likelihood ratios close to 1 - <40 y/o, M>F, >3 mo, insidious - Worse a.m., rest; better w/activity

- 4u -

- SI jt exam not accurate (I advise doing something more useful with your limited time)

- HLA B27 for ank spond Dx (sens 90-95%, spec 93% in caucasians)

For Patients with Leg Pain Back Pain (i.e., sciatica)

1. Herniated nucleus pulposus (HNP) - Age 25-50, 98% L4-5 (L5 root) – weak ankle & great toe

dorsiflexors, sensory loss medial foot - or L5-S1 (S1) – weak ankle plantar flexion, ankle jerk, sensory loss lateral foot; rare CES

- Protrusion of gelatinous NP thru weak annulus - Recurrent BP x 3 yr mean, then HNP - Risks: sedentary occupation, obesity, cigs - 4 cardinal features

1) Predominant sx of root pain (leg>back) 2) Root irritation (straight leg raise [SLR] – not very specific for

HNP, 80% sens; crossed SLR 90% spec, 25% sens) 3) Root compression (weak foot/ ank jerk in ? 85%) 4) Compatible imaging

2. Lumbar spinal stenosis

- Condition involving any type of narrowing of spinal canal, nerve root canals, or tunnels of intervertebral foramina

- Prevalence unknown, inc in elderly - Can be caused by bone (facet hypertrophy), bulging disk, thickened

or bowing (from height loss) ligamentum flavum, postop fibrosis – acquired degenerative stenosis most common

- Pseudoclaudication in 60-90% Def: discomfort in butt(s), thigh(s), or leg(s) on standing or walking & relieved by rest - pain, numbness, or weakness - relieved by sitting (52%) or flexing – inc capacity of canal in

flexion - bilateral in most - entire leg in 78% (below knee alone in 7%) (Hall ’85) - probably due to mechanical compression of nerve roots

- PE findings meager – about 1/3 – dec reflex, weakness - Levels of stenosis – L1 3%, L2 26%, L3 44%, L4 55%, L5 14%; at

only L1 and/or L2 in 9% - Dx: MR if pt is surgical candidate – note that >20% over 60 y/o

with NO sx/limits have some spinal stenosis

- 4v -

Pseudoclaudication True

Claudication Foot pulses Standing produces Distance tolerated Back pain LE sensory loss

Normal* Pain

Variable +

Segmental

Dec Relief

Constant -

Stocking *but an older population who may have concomitant arterial disease

- Wide-based gait in 43% - specificity 97% (Katz, A&R 38:1236, 1995)

- Sx improve when seated in 52% - spec 83% - Rat’l Clin Exam ’10- - +LRs for whether leg pain is 2º to sp stenosis - No pain seated = 7.4, ↓ Sx bending = 6.4, bilateral butt or leg pain = 6.3, pseudoclaudication = 3.7 (Suri ’10). C. “Nonspecific” back pain (some caused by degenerative arthritis)

- 90% of cases of back pain - ? ligament vs facet jt vs annulus vs muscle vs ?

- Pain may come from nerve ingrowth into diseased disk (found in 57% pain levels vs 25% without pain – Freemont ’97)

- Risks: repetitive lifting, cigs, unhappiness, kids, prior LBP - 90% better at 4-6 wks a commonly cited stat (Koes ’01, Spine)

- but in ‘03 metaanalysis, pain by 60% at 1 month, continued improvement to 3 mos; recurrence in ¼ in 3 mo, ¾ in 1 yr (Pengel ’03)

- Inception cohort – 83% returned to previous work status by 3 mos; median 58 days for pain resolution; only 72% completely recovered at 12 mos (Henschke ’08) - Of pts with ≥12 wks pain, 1/3 ok 9 mos later.

- Rat’l Clinical Exam ’10 – predictors of disabling chronicity? – “non-organic signs” had +LR = 3, all others <3.

D. Misc physical exam stuff - Reproducibility (i.e. reliability or precision) of PE only poor-moderate

- Leg pain on SLR ? – Kappa(K)=0.66 (K<0.4 poor; - Nl ank jerk? K = 0.39 0.4-0.7 moderate; - Bone tenderness ? K = 0.4 >0.7 very good)

- If LBP alone, neuro impairment rare – do minimalist exam - With sciatica , concentrate on

1) weakness ankle/great toe dorsiflexors? (L5) 2) dec ank jerk? (S1) 3) sens (pinprick) loss in foot (L5 & S1)

- SLR (tests L5 & S1 roots) + if radicular pain at 60 elevation; sens = 80%, but 60% FP; cross SLR (contralateral) 58/351 +; 56/58 true + for disk

- 4w -

- Sensory loss most frequent in distal part of dermatome [medial (L4), dorsal (L5), lateral (S1) foot]

- Accuracy of neuro findings for diagnosis of herniated disk only moderate - + pred value of dec sens L5 + wk ft dorsiflexion = 76%

Level Root Pain/Dysesthesia Weakness Decreased DTR

L3-4 L4 Med lower leg Med malleolus

Foot inversion, dorsiflexion; quad

Knee

L4-5 L5 (+/- S1) Lat lower leg dorsal foot

Ext great toe, dorsiflexor foot

-

L5-S1 S1 Lat & plantar foot Foot eversion, plantar flexion

Ankle

Plain X-ray A. Problems

1) Low specificity of “abnormalities” - DJD seen in asymptomatics – as often as LBP pts (i.e., LR close to

1) - by age 50, 90% have spondylosis (ant ‘phytes); 80% with LBP vs 67% without have degen disc disease

- No correlation between LBP and presence of asymmetric vertebrae, transitional vert, spina bifida, Schmorl’s nodes; vacuum sign L3-4 or narrow L5-S1 (Ingall ’84); spondylolysis

- LBP in 84% with spondylolisthesis vs 57% controls - Of 500 pts who had pelvic CT but no h/o LBP, 65% had SI joint

“degeneration”, 30% “substantial”, w/age (Eno ’15) 2) Low yield for “treatable disease”

- Rare (see above) - Falsely neg in 10% osteo (specificity 57%), 75% epidural infection,

1/3 cancer - Jarvik cohort ’15 – 1 yr outcome of >65 y/o’s with early imaging for

LBP no better; “regardless of age, early imaging should not be performed routinely”.

3) Only fair reliability 4) Gonadal irradiation

- ½ from oblique views - Rads = 75 chest radiographs

B. Indications 1) Only if “red flags” (grade C evidence, AHCPR ’94 rec) (Deyo ’02)

- Possible fx: major trauma, chronic steroid, >70 - Tumor/ID: >50, hx Ca, recent infection

- nocturnal pain very nonspecific - Red flags falling into disfavor as of 2015 – poor predictive value plus imprecise estimates of LRs from literature - For fracture: only 4 studies in 1° care - “sig trauma” LR+ 3-12 - “older age” 3-9 - steroid use 4-48

- 4x -

- High FP rates (Cochrane ’13): - For malignancy: 6 studies in 1° care, prevalence 0-0.66% Ca - High FP rates for insidious onset, age >50, failure to improve after 1 month - Some evidence for prior h/o Ca (Cochrane ’13)

2) Major neuro deficits? - just go straight to MR 3) Persistent pain after 6 wks?

- Risks of delay: palliative Rx for epidural met; Rx of infection - Do AP & lat only; not obliques; not the useless coned L5-S1 - Note in an RCT, pts randomized to X-ray had more pain & disability at 3 mo than

those who didn’t get X-rayed; no diff at 9 mo, but they were happier! (Kendrick ’01)

- 2015 cohort study - early imaging did not improve 1 yr outcomes (Jarvik ’15) MRI A. Problems

1) Low specificity of “abnormalities” - In asx, degenerative disk disease (DDD) in 90% > 60y/o

disk bulge in 50%, protrusion 29%, true disk rupture <1% annular defect 14%, facet OA 8% listhesis/lysis 7%, stenosis 20%

- Same for C&T spine 2) “Abnormality” may heighten pt anxiety, illness behavior/labeling, chance of surgery - RCT of immediate MRI vs not showed no benefit (Jarvik ’03) - Rate of MR L-spine imaging ↑ 307% ’94-’05 (Deyo ’09)

B. Indications for MRI

1) Candidate for disk surgery (sciatica + neuro sign + 6 wks elapsed) 2) Possible CES 3) Progressive neuro deficit 4) Reasonable likelihood of tumor or infection 5) Candidate for spinal stenosis surgery

- ’02 metaanalysis (Deyo) – sensitivity 83-93%, spec 90-97% for cancer 96% 92% for infection 56% - for AS

Treatment of Low Back Pain Acute: “Hard to prove that most treatments result in greater improvement than the nonspecific effects of natural history, placebo & regression to the mean” (Deyo

’04 Ann Int Med) - NSAIDs, muscle relaxant & spinal manipulation > placebo, but modestly

so

- 4y -

Chronic: Natural history less favorable than acute, but “similarly difficult to prove that most treatments are better than nonspecific effects alone” (Deyo ’04)

LS Radicular: “At present there is no evidence that one type of (nonsurgical) treatment is clearly superior to no treatment (Luijsterburg ’07 systematic review) Note: The spine literature is so methodologically flawed (& relatively devoid of randomized trials) that definitive conclusions are not often possible. Non-Pharmacologic - No clear advantage of any particular Rx method (PT, exercise, massage,

manipulation by chiropractors or other manual medicine providers, low impact aerobics or reconditioning on training machines) (Carragee ’05)

- RCT ’07 (Eisenberg) – n = 444 acute LBP – usual care alone vs adding pt choice of adjunctive complementary/alternative Rx x 5 wks – no benefit but happier and cost.

A. Bedrest

- Deyo ’86 RCT – 2 vs 7 day, n = 203, walk-in pts: 7 d gp missed more work, no difference at 3 wks

- Malmivaara ’95 RCT – 2 d rest vs exercise vs ordinary activity; acute, n=186, occup hlth setting - Rest gp had more sick days, pain & disability - Exercise gp had slower recovery & most expensive - Benign neglect best on all endpoints

- Vroomen ’99 RCT – 2 wks vs reasonable activity, n =183 with sciatica - No difference, even if n. root compression on MRI

- ?? OK if HNP & motor deficit (intra-discs pressure supine only 25-50% of standing; supported sitting 50% greater than standing) (no real evidence though for bedrest)

- Despite a long history of rumor-based medicine (RBM) recommendations to use a very firm mattress, RCT showed worse outcome compared to medium firm! (Kovacs ’03)

B. Exercise PT - No benefit for acute or subacute

- Meta ’05 (Hayden) – chronic LBP - exercise Rx improved f’n & pain > no Rx, placebo or other

conservative Rx at 6-12 wks, 6 mo and at 12 mo - benefit fairly modest

- best if individually designed, at home but with therapist followup, high-dose or –intensity; & in conjunction with additional conservative care (e.g., advice to stay active, NSAIDs, or manual therapy)

- best types: stretching for pain strengthening for f’n

- 4z -

- Intensive multidisciplinary biopsychosocial rehab & f’nal restoration reduced pain, f’n in chronic LBP (Guzman ’01) - but program content varies & can’t extrapolate to your practice

setting; also costly - Graded activity program in Netherlands occ med clinic resulted in more

rapid return to work (58 vs 87 days) – pts taught that pain is benign, safe to return to work (Staal ’04)

C. PT Modalities

- TCNS: real = sham (Deyo’90, Moore ’97) - Traction: real = sham at 5 wks, 44 vs 51% pts much improved

(Buerskens ’95) - 3 prior RCTs (1 neck) which were ok methodologically (>50/100

points) – all showed no benefit - No convincing evidence for “modalities” – i.e., ultrasound, laser,

diathermy, . . . - 2015 RCT – no benefit for “PT” for acute LBP (Fritz ’15)

D. Manipulation - Acute – recovery at 3 wks: with = 67% vs 50% without (absolute risk

reduction = 67-50 = 17%, # needed to manipulate to benefit one patient = 100/17 = 6) - No difference 3 wks later or long term - Studies poorly done (only 4/25 scored >50/100 points) (Shekelle

’92 meta-analysis) - Chronic – no better than placebo PT; but both better than nothing (i.e.

routine GP care)! – nonspecific benefit of referral (Koes’ 92) - Osteopathic manip = std medical Rx, 12 wks, n=178 (only approx

15% of all pts screened were eligible) (Andersson ’99) - PT vs chiro vs educational booklet, RCT, n=321 w/LBP (75% <6 wks)

(Cherkin ’98) - cost & PT/chiro happier, but no real sig benefit re LBP

- ’03 metaanalysis – for acute or chronic LBP, not better than routine GP care, analgesics, PT; but mildly better than sham manipulation(Assendelft ’03)

- Risks - ? 1/20K – 1/million vertebrobasilar CVA (esp with rotatory neck manip); disc herniation, CES (<1/million)

- Cochrane 2011: 26 RCTs – “high quality evidence of a small but not clinically relevant short-term effect on pain and functional status compared to other interventions” for chronic LBP.

E. Acupuncture - Bottom line: As with OA, real acupuncture minimally better than sham, but sham def beats doing nothing! - Meta ’05 (Manheimer) - Better than sham (short-term) for chronic – effective size 0.4 - No evidence it is better than other active treatments

- Brinkhaus ’06 – n=298 acupunc v. sham v. no Rx x 8 wks

- 4aa -

- both much better than no Rx; sham close to real acupunc - Thomas ’06 – n=241 – acupunc x 10 v. “usual care” - 10-15% better re pain - Cherkin ’09 – “individualized” no better than standard which again = sham;

all better than “usual care”. F. Massage - Those who expect it to help get more benefit

- pt’s initial confidence in assigned Rx correlates with outcome better than the assigned Rx! (see Eisenberg ’07 for opposite results)

- 3 RCTs by ’03 – more effective than acupuncture (Cherkin ’03) - RCT – Cherkin ’11 – 10 wkly sessions > usual care (no sham) - Cochrane 2015: “We have very little confidence that massage is effective for LBP”. G. Yoga

- n=101, RCT, chronic LBP, 12 wks; more effective than a self-care book for improving f’n & pain, benefits persisted for several months; but a yoga-oriented cohort in NW & not blinded. (Sherman ’05)

- 12 wk RCT – modest benefit over “usual care” (Tilbrook ’11) - Benefit = stretching exercise, both slightly > “self-care book” (Sherman

’11). H. “Self-Management” - Meta – moderate quality evidence of no sig benefit (Oliveira ’12) I. “Mind-Body Approaches” - CBT, mindfulness meditation (plus yoga) to change pain-related thoughts and behaviors - both better than “usual care” in Cherkin ’16 RCT - disability (NNT 7) and pain (NNT 6) for chronic LBP 1 year out - Morone ’16 RCT of mind-body program – modest short-term function, long-term pain Pharmacologic A. Corticosteroid injections

- Facet jts – 2 RCTs, = saline (Carette ’91) - ’06 European guidelines recommend against

- Epidural (for sciatica/HNP) - Definitive meta 2012 – 23 trials; small short-term benefit over

placebo for leg pain and disability and of ?clinical utility (not to mention cost-effectiveness or risks) (Pinto ’12)

- ’07 Am Acad Neuro (Armon ’07) – small benefit at 2-6 wks, data poor; does not f’n, need for surgery, or give pain relief beyond 3 mos

- In 2011, 2.3 million done among Medicare pts alone!! And increasing! (Shame!) B. Oral drugs - NSAIDs modestly efficacious

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- Cochrane – 16 “high quality” RCTs thru Sept ’98; > placebo for acute, but insufficient evidence for chronic LBP; unclear if better than acetaminophen, though no evidence for latter (Bjordal ’08)

- Acetaminophen - Lge RCT 2014 – did not hasten recovery time for acute LBP

(Williams ’14) - Opioid for severe acute, short-term - 2015 RCT for acute LBP: added oxycodone 5 mg 1-2 q8 to naproxen 500 mg b.i.d. no better than nap alone after 1 wk (Friedman ’15) - Cochrane 2013: opioids v. placebo for chronic LBP – 15 RCTs; tramadol ES 0.55 for pain (low quality evidence); strong opioids ES 0.43 for pain (moderate quality evidence) and 0.26 for function; trials of short duration: Conc: “some evidence for short-term efficacy”; use “extreme caution” if long-term Rx - “Muscle relaxants” - 4 RCTs as of ’08 – only 1 had sig benefit - 2015 RCT for acute LBP – cyclobenzaprine + naproxen no better than nap alone (Friedman ’15) - Antidepressants - Meta ’02 (Salerno) – 9 RCTs, modest pain, no f’n benefit - Meta ’03 (Deyo) – 7 RCTs

- Antidepressants that inhibit norepi (e.g., nortriptyline) moderately effective (effect size 0.43)

- Paroxetine = placebo (1 trial) - Thus, very little data - Systemic prednisone – meta ’11 - ↑ toxicity, ↑ surg rate! (Roncoroni ’11) - 2015 RCT for HNP sciatica – 2 wk 60 mg 0 taper – modest f’n, no pain benefit (Goldberg ’15) Surgery - Miscellaneous

- “Absent major neurologic deficits, pts with herniated disks, degenerative spondylolisthesis, or spinal stenosis do not need surgery, but the appropriate surgical procedures may provide pain relief.” (Deyo ’07)

- Rate increased 55% ’79 – ’90 – marked increase in Dx HNP (CT, MR) - greatest relative increase for spinal stenosis (>4 x) - rate varies 5-fold among states (WA #1, OR #6) - rate at least 40% higher in US than any other country (Cherkin ’94)

- Fusions - 250,000 done in’03 in US, 3 x as many as ’93, $2.5 billion just for

the hardware! (NY Times, Dec 31, 2003); >300K in ‘04 - no benefit for HNP; conflicting results for “diskogenic” pain - no proof of benefit for degenerative disease (back or neck) - fusion with implants (pedicle screws), even if a marginal advantage

is hypothesized, costs >$3 million per QALY (quality adj life yr) compared with old fashioned non-instrumented fusion

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- RCT – intensive rehab outcome fusion (Fairbank ’05) - ’07 review (Mirza) – for “discogenic back pain”, 4 trials found – no

firm conclusions possible - Rate of complex fusions ↑ 15-fold ’02-’07-OR for life-threatening

complication = 2.9, 10 x higher reimbursement. - Choice of which procedure less important than choice of patient

- HNP - Surgical candidate if 1) sciatica + 2) pos imaging + 3) neuro deficit, + 4) 6-

12 wk failure (although ½ of these will respond to further conservative Rx) - Cochrane ’99 – “considerable evidence” of clinical effectiveness of

diskectomy for carefully selected pts with sciatica secondary to HNP – faster relief

- RCT – Peul ’08 – n=283, 6-12 wks sciatica, microdiskectomy – faster relief of leg pain; 95% perceived recovery at 1 yr in both groups (40% of nonsurg pts wound up with surgery)

- Prospective cohort study of sciatica/HNP (Atlas ’05) - 10 yr outcomes in 400/477 surviving pts - 25% reoperate, 25% nonsurg pts had 1 surgery - 69% surg vs 61% nonsurg pts improved at 10 yrs

- much improved in 56 vs 40% - surg pts had better relief, improved f’n - RCT, n=56; microdiskectomy recovery more rapid (Osterman ’06) - At 1 yr post-op, 1/3 still show HNP on MRI, 1/3 n. root compression – does not correlate with sx (el Darzouhi ’13). - Spinal stenosis

- Prospective cohort study, Atlas ’05 – surgery group better at 1 and 4 yrs, at 8-10 yrs (n=120), 50% each gp satisfied; at 10 yrs, 23% reop rate

- 1st RCT ’07 Malmivaara – n=only 94; sig improvement at 1 yr in back & leg pain

- 2nd RCT ’08 Weinstein – 4+ crossovers – as treated analysis surgery better at 1 & 2 yrs (mean age 66) – 31% back pain, 41% leg pain - even non-surg pts showed moderate improvement - periop mortality 0.6%

- Spinal instability from multilevel surgery may require fusion - (of course) epidural steroids don’t help! (Chou ’15) - RCT ’15 – n=169, 24 mo, PT v. surg – no significant difference, but large (57%!) crossover from PT surgery makes result very questionable (Delitto ’15) - Artificial disks – efficacy & risks very unclear in 2013

- results fusion (“faint praise” – Deyo ’04) - Radiofrequency lesioning of dorsal root ganglia for sciatica

- in sham controlled RCT, 16% vs 25% (Sham) success – “thus its use should not be advocated” (Geurts ’03)

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Prevention - USPSTF Feb ’04: Insufficient evidence to recommend for or against routine

interventions to prevent low back pain in primary care settings. - Review ’08 (Martimo) – no evidence to support use of advice or training in work

techniques (i.e., lifting) for preventing back pain or disability A. Education

- RCT back school, n=4K postal workers: 2%/yr LB injury, rel risk 10% higher (1.1) if schooled, cost 3 x higher - “failure to change behavior” (Daltroy ’97)

- Do we really know what to teach? - Cochrane ’06 (lit thru 11/04) – schools may help in occupational setting in

short – intermediate term B. Exercise

- ? mildly protective (aerobic = strengthening) C. Corsets – no evidence

- RCT of lumbar support for cargo wkrs – no difference in back pain rate or sick leave (van Poppel ’98)

- Cochrane (lit thru 9/99) – 5 RCTs – no evidence for secondary prevention D. Risk modification – no studies - Meta ’16 - ? exercise +/- education lowered risk of LBP episode, but data low quality, short-term and meager! (Steffens ’16) Overview of Rx for Nonspecific Back Pain Acute

- Analgesics at regular intervals - Quick return to nl activity – guided by goals, not pain - Tincture of time

Chronic – “little consensus” (Carragee, NEJM ’05) - Some kind of exercise; PT referral ? - ? short-term massage, manual Rx, acupuncture per pt desire &

expectation of benefit - Analgesics may help; try to avoid opioids - if sciatica, surgery for disk etiology in selected pts - difficult to avoid being nihilistic if you’re evidence-based but perhaps most

important is that pts feel & do better if we do something (that doesn’t work) rather than do nothing. - Feine ’97 NIH Technology Assessment

- PT Rx (probably = placebo) worked better than doing nothing in 15/16 studies

- but if controls were given placebo PT (i.e., something), real PT better in only 7/22 studies.

- The “nonspecific” benefit of acupuncture or sham acupuncture is not trivial

- Pt response seems to correlate with expectation of benefit

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What not to do – bedrest, exercise for acute, prolonged manipulation, traction, corset, injections (facet, epidural) or surgery (if no radiculopathy)

Summary A. Fiction

1) There is consensus on the most effective approach to spine pain. 2) The literature allows definitive conclusions. 3) Current practice is based on evidence. 4) One of the following has been shown to have benefit above & beyond

placebo Rest Traction Injection Acupuncture TCNS Fusion PT Corset Education Advice

B. Fancy 1) Exercise helps chronic spine pain. 2) The linear relationship between surgical rates and the # of surgeons is

coincidental. 3) The lower rate of surgery in Britain is secondary to inadequate access to

care. 4) Surgeons will start doing randomized trials.

C. Facts 1) The spine literature is very difficult to process. 2) Most patients do well with benign neglect. 3) Specifically treatable etiologies are uncommon. 4) Sham TCNS, sham traction & sham acupuncture may help. 5) Pts will feel and do better if given something that doesn’t really work than

if given nothing.

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References (bolded = particularly worthwhile) Back Pain/Sciatica A. General

Ropper A et al. Sciatica. N Engl J Med 2015;372:1240-8. Chou R. in the Clinic Low Back Pain. Ann Intern Med, June 3, 2014; iTC 1-16 Chou R et al. Will this patient develop persistent disabling low back pain? JAMA 2010;303(13):1295-1302. Freburger JK et al. The rising prevalence of chronic low back pain. Arch Intern Med 2009; 169:251-258. Menezes Costa et al. Prognosis for patients with chronic low back pain: inception cohort study. BMJ 2009:339.b3829. Martin BI et al. Expenditures and health status among adults with back and neck problems. JAMA 299:656-64, 2008. Henschke N et al. Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study. BMJ 337:a171, 2008. Balague F et al. Clinical update: Low back pain. The Lancet 369:726-8, 2007 Comment. Clinical update: Low back pain. The Lancet 369:726-28, 2007. Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ 332:1430-34, 2006. Carragee EJ. Persistent low back pain. N Engl J Med 352:1891-8, 2005. Pengel LHM, Herbet RD, Maher CG et al. Acute low back pain: systematic review of its prognosis. BMJ 327:323-5, 2003. Deyo RA, Weinstein JN. Low back pain. N Engl J Med 344:363-70, 2001. Andersson G. Epidemiological features of chronic low back pain. Lancet 354:581-5, 1999. Freemont AJ, Peacock TE, Gopuille P et al. Nerve ingrowth into diseased intervertebral disc in chronic back pain. Lancet 350:178-81, 1997. Hart LG, Deyo RA, Cherkin DC. Physician office visits for low back pain. Spine 20:11-19, 1995.

B. Diagnosis/Etiologies Eno JJ et al. The prevalence of sacroiliac joint degeneration in asymptomatic adults. J Bone Joint Surg Am 2015; 97:932-6. Jarvik JG et al. Association of early imaging for back pain with clinical outcomes in older adults. JAMA 2015;313(11):1143-53.

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Laporte C et al. MRI investigation of radiating pain in the lower limbs: value of an additional sequence dedicated to the lumbosacral plexus and pelvic girdle. AJR 2014;203:1280-1285. Deyo RA et al. Rational imaging: Low back pain in primary care. BMJ 2014;349:G4266 Downie A et al. Red flags to screen for malignancy and fracture in patients with low back pain: systematic review. BMJ 2013;347:f7095. Williams CM et al. Red flags to screen for vertebral fracture in patients presenting with low-back pain. Cochrane Database Syst Rev 2013;1:CD0087643. Henschke N et al. Red flags to screen for malignancy in patients with low back pain. Cochrane Database of System Rev 2013;2:CD008686 el Barzouhi A et al. Magnetic resonance imaging in followup assessment of sciatica. N Engl J Med 2013;368:999. Srinivas SV et al. Application of “less is more” to low back pain. Arch Intern Med 2012;172(13):1016-1020. Chou R et al. Diagnostic imaging for low back pain: advice for high-value health care from the American College of Physicians. Ann Intern Med 2011;154:181-189.

Zimmerli W. Vertebral osteomyelitis. N Engl J Med 2010;362:1022-1029. Suri P et al. Does this older adult with lower extremity pain have the clinical syndrome of lumbar spinal stenosis.JAMA 2010;304(23)2628-2636. Chou R et al. Imaging strategies for low-back pain: systematic review and meta-analysis. The Lancet 2009;373:463-471. Deyo RA. Imaging idolatry. Arch Intern Med 2009;169(10):921-923. Henschke N et al. Prevalence of and screening for serious spinal pathology in patients presenting to primary care settings with acute low back pain. Arthritis Rheum 2009;60(10):3072-3080. Underwood M. Diagnosing acute nonspecific low back pain: time to lower the red flags? Arthritis Rheum 2009;60(10):2855-2857. Katz JN, Harris MB. Lumbar spinal stenosis. N Engl J Med 358:818-25, 2008.

Cauley JA et al. Long-term risk of incident vertebral fractures. JAMA 298:2761-67, 2007. Darouiche RO. Spinal epidural abscess. N Engl J Med 355:2012-20, 2006. Jarvik JG, Hollingworth W, Martin B, et al. Rapid magnetic resonance imaging vs radiographs for patients with low back pain. JAMA 289:2810-18, 2003.

Jarvik JG, Deyo RA. Diagnostic evaluation of low back pain with emphasis on imaging. Ann Intern Med 137:586-97, 2002. Deyo RA. Diagnostic evaluation of LBP. Arch Intern Med 162:1444-48, 2002. Kendrick D et al. Radiography of the lumbar spine in primary care patients with low back pain: randomized control trial. BMJ 322:400-5, 2001.

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Nevitt MC et al. The association of radiographically detected vertebral fractures with back pain and function: A prospective study. Ann Intern Med 128:793-800, 1998. Schiff D, O’Neill BP, Suman VJ. Spinal epidural metastasis as the initial manifestation of malignancy: Clinical features and diagnostic approach. Neurology 49:452-456, 1997. Suarez-Almazor ME, Belseck E, Russell AS, et al. Use of lumbar radiographs for the early diagnosis of low back pain. JAMA 277:1782-1786, 1997. Deyo RA. Magnetic resonance imaging of the lumbar spine. Terrific test or tar baby? N Engl J Med 331:115-116, 1994. Jensen MC, Brant-Zawadzki MN, Obuchowski N, et al. Magnetic resonance imaging of the lumbar spine in people without back pain. N Engl J Med 331:69-73, 1994. Byrne TN. Spinal cord compression from epidural metastases. N Engl J Med 327:614-619, 1992. Deyo RA, Rainville J, Kent DL. What can the history and physical examination tell us about low back pain? JAMA 268:760-765, 1992. McCombe PF, Fairbank JCT, Cockersole BC et al. Reproducibility of physical signs in low back pain. Spine 14:908-918, 1989.

Deyo R et al. Cancer as a cause of back pain. J Gen Intern Med 3:230-238, 1988.

Cantwell BMJ, Mannix KA, Harris AL. Back pain – a presentation of metastatic testicular germ cell tumours. The Lancet 1:262-264, 1987.

Powell MC, Szypryt P, Wilson M et al. Prevalence of lumbar disc degeneration observed by magnetic resonance in symptomless women. The Lancet 1:1366-1367, 1986.

Deyo RA, McNiesh LM, Cone RO. Observer variability in the interpretation of lumbar spine radiographs. Arthritis Rheum 28:1066-1070, 1985.

Hall S, Bartleson JD, Onofrio BM, et al. Lumbar spinal stenosis. Clinical features, diagnostic procedures, and results of surgical treatment in 68 patients. Ann Intern Med 103:271-275, 1985.

C. Treatment Cherkin DC et al. Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain. A randomized clinical trial. JAMA 2016;315:1240-1249. Morone NE et al. A mind-body program for older adults with chronic low back pain. A randomized clinical trial. JAMA Intern Med 2016;176:329-337. Steffens D et al. Prevention of low back pain. A systematic review and meta-analysis. JAMA Intern Med Jan 2016; doi:10.1001/jamainternmed.2015.7431. Delitto A et al. Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial. Ann Intern Med 2015;162:465-73. Furlan AD et al. Massage for low-back pain. Cochrane Database Syst Rev 2015;9:CD001929.

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Goldberg H et al. Oral steroids for acute radiculopathy due to a herniated lumbar disk. JAMA 2015;313(19):1915-1923. Friedman BW et al. Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain. JAMA 2015;314(15):1572-1580. Chou R et al. Epidural corticosteroid injections for radiculopathy and spinal stenosis. A systematic review and meta-analysis. Ann Intern Med 2015;163:373-381. Fritz JM et al. Early physical therapy vs usual care in patients with recent onset low back pain. JAMA 2015;314(14):1459-1467, Katz JN. Surgery for lumbar spinal stenosis: informed patient preferences should weigh heavily. Ann Intern Med 2015;162:518-519. Williams CM. Efficacy of paracetamol for acute low back pain: a double-blind, randomized controlled trial. Lancet 2014;384:1586-96. Chaparro LE et al. Opioids compared to placebo or other treatments for chronic low back pain. Cochrane Database Syst Rev 2013;8:CD004959.

Pinto RZ et al. Epidural corticosteroid injections in the management of sciatica. Ann Intern Med 2012;157:865-877. Oliveira VC et al. Effectiveness of self-management of low back pain: systematic review with meta-analysis. Arthritis Care Res 2012;64(11):1739-1748. Rubinstein SM et al. Spinal manipulative therapy for chronic low-back pain. Cochrane Database Syst Rev 2011; Roncoroni C et al. Efficacy and tolerance of systemic steroids in sciatica: a systematic review and meta-analysis. Rheumatology 2011;50:1603-1611. Staples MP et al. Effectiveness of vertebroplasty using individual patient data from two randomized placebo controlled trials: meta-anslysis. BMJ 2011;343:d3952 doi 10.11356/bmj.d3952. Tilbrook HE et al. Yoga for chronic low back pain. Ann Intern Med 2011;155:569-578. Sherman KJ et al. A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain. Arch Intern Med 2011;171(22):2019-2026. Cherkin DC et al. A comparison of the effects of 2 types of massage and usual care on chronic low back pain. Ann Intern Med 2011;155:1-9. Carragee EJ. The increasing morbidity of elective spinal stenosis surgery. JAMA 2010;303(13):1309-1310. Deyo RA et al. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 2010;303(13)1259-1265. Cherkin DC et al. A randomized trial comparing acupuncture, simulated acupuncture and usual care for chronic low back pain. Arch Intern Med 2009;169(9):858-866. Buchbinder R et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009;361:557-68.

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Kallmes DF et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361:569-79. Weinstein JN et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med 2008;358:794-810. Peul WC et al. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: Two year results of a randomized controlled trial. BMJ 2008;336:1355. Martimo K-: et al. Effective of training and lifting equipment for preventing back pain in lifting and handling: systematic review. BMJ 2008 doi:10.1136/bmj39463.418380 BE. Martimo KP et al. Effect of training and lifting equipment for preventing back pain in lifting and handling: systematic review. BMJ 336:429-31, 2008. Bjordal JM et al. Overviews and systematic reviews on low back pain. Ann Intern Med 148:789-790, 2008. Eisenberg DM et al. Addition of choice of complementary therapies to usual care for acute low back pain. Spine 32:151-58, 2007. Luijsterburg PA et al. Effectiveness of conservative treatments for the lumbosacral radicular syndrome: a systematic review. Eur Spine J 16:881-99, 2007. Peul WC et al. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med 356:2245-56, 2007. Mirza SK, Deyo RA. Systematic review of randomized trials comparing lumbar fusion surgery to nonoperative care for treatment of chronic back pain. Spine 32:816-23, 2007. Weinstein JN et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med 356:2257-70, 2007. Deyo RA. Back surgery – who needs it? N Engl J Med 356:2239-43, 2007. Malmivaara A et al. Surgical or nonoperative treatment for lumbar spinal stenosis? Spine 32:1-8, 2007. Carragee E. Surgical treatment of lumbar disk disorders. JAMA 296:2485-87, 2006. Airaksinen O, Brox JI, Cedraschi C on behalf of the COST B13 Working Group on Guidelines for Chronic Low Back pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J 15(suppl2):S136-68, 2006. Osterman H, et al. Effectiveness of microdiscectomy for lumbar disc herniation: a randomized controlled trial with 2 years of follow-up. Spine 31:2409-14, 2006. Thomas KJ, et al. Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain. BMJ, doi:10.1136/bmj.38878.907361.7C (Sept 15) 2006. Brinkhaus B et al. Acupuncture in patients with chronic low back pain. Arch Intern Med 166:450-57, 2006.

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Sherman KJ et al. Comparing yoga, exercise and a self-care book for chronic low back pain: a randomized, controlled trial. Ann Intern Med 143:849-56, 2005. Furlan AD. Acupuncture and dry-needling for low back pain: An updated systematic review within the framework of the Cochrane collaboration. Spine 38:944-63, 2005.

Atlas SJ et al. Long-term outcomes of surgical and nonsurgical management of lumbar spine stenosis: 8-10 year results from the Maine lumbar spine study. Spine 30(8):936-43, 2005. Atlas SJ et al. Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the Maine lumbar spine study. Spine 30(8):927-35, 2005. Fairbank J et al. Randomised controlled trial to compare surgical stabilization of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: The MRC spine stabilization trial. BMJ 330:1233, 2005.

Hayden JA et al. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med 142:765-775, 2005. Hayden JA et al. Systematic review: Strategies for using exercise therapy to improve outcomes in chronic low back pain. Ann Intern Med 142:776-785, 2005. Manheimer E et al. Meta-analysis: Acupuncture for low back pain. Ann Intern Med 142:651-663, 2005. Deyo RA et al. Spinal-fusion surgery- the case for restraint. N Engl J Med 350:722-726, 2004.

USPSTF. Primary care interventions to prevent low back pain in adults. Guide to Clinical Preventive Services, 2nd Edition. February, 2004. Deyo RA. Treatments for back pain: can we get past trivial effects? Editorial. Ann Intern Med 141:957-958, 2004.

Staal, JB, Hlobil H, Twisk JWR, et al. Graded activity for low back pain in occupational health care. Ann Intern Med 140:77-84, 2004.

Staiger TO et al. Systematic review of antidepressants in the treatment of chronic low back pain. Spine 28:2540-5, 2003. Kovacs FM, Abraira V, Pena A, et al. Effect of firmness of mattress on chronic non-specific low-back pain: randomized, double-blind, controlled, multicentre trial. Lancet 362:1599-604, 2003. Cherkin DC, Sherman KJ, Deyo RA et al. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med 138:898-906, 2003. Assendelft WJ, Morton SC, Yu EI et al. Spinal manipulative therapy for low back pain: a meta-analysis of effectiveness relative to other therapies. Ann Intern Med 138:871-82, 2003. Salerno SM, Browning R, Jackson JL. The effect of antidepressant treatment on chronic back pain. Arch Intern Med 162:19-24, 2002.

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Kalauokalani D et al. Lessons from a trial of acupuncture and massage for low back pain: patient expectations and treatment effects. Spine 26:1418-24, 2001. Guzman J, Esmail R, Karjalainen K et al. Multidisciplinary rehabilitation for chronic low back pain: systematic review. BMJ 322:1511-6, 2001. Browning R, Jackson JL, O’Malley PG. Cyclobenzaprine and back pain. Arch Intern Med 161:1613-20, 2001. Nevitt M et al. Effect of alendronate on limited activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Arch Intern Med 160:77-85, 2000. Andersson G et al. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med 341:1426-31, 1999. Vroomen P et al. Lack of effectiveness of bedrest for sciatica. N Engl J Med 340:418-23, 1999. Cherkin DC et al. A comparison of physical therapy, chiropractic manipulation and provision of an educational booklet for the treatment of patients with low back pain. N Engl J Med 339:1021-9, 1998. Van Poppel M et al. Lumbar supports and education for the prevention of low back pain in industry. JAMA 279:1789-94, 1998. Van Tulder MW et al. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine 22:2128-56, 1997. Carette S, Leclaire R, Marcoux S, et al. Epidural corticosteroid injections for sciatica due to herniated nucleus pulposus. N Engl J Med 336:1634-1640, 1997. Daltroy LH, Iversen MD, Martin SD et al. A controlled trial of an educational program to prevent low back injuries. N Engl J Med 337:322-328, 1997. Feine JS, Lund JP. An assessment of the efficacy of physical therapy and physical modalities for the control of chronic musculoskeletal pain. Pain 71:5-23, 1997. Assendelft WJJ, Bouter LM, Knipschild PG et al. Complications of spinal manipulations. A comprehensive review of the literature. J Fam Pract 42:475-480, 1996. Ciol MA, Deyo RA, Howell E, et al. An assessment of surgery for spinal stenosis: Time trends, geographic variations, complications, and reoperations. J Am Geriatr Soc 44:285-290, 1996. Deyo RA. Acute low back pain: A new paradigm for management. Br Med J 313:1343-1344, 1996. Assendelft WJJ, Koes BW, Knipschild PG et al. The relationship between methodological quality and conclusions in review of spinal manipulation. JAMA 274:1942-1948, 1995. Beurskens AJ, de Vet HC, Koke AJ et al. Efficacy of traction for non-specific low back pain: a randomised clinical trial. The Lancet 346:1596-1600, 1995. Carey TS, Garrett J, Jackman A et al. The outcomes and costs of care for acute low back pain among patients seen by primary care practitioners, chiropractors, and orthopedic surgeons. N Engl J Med 333:913-917, 1995.

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Malmivaara A, Hakkinen U, Aro T et al. The treatment of acute low back pain – bedrest, exercises, or ordinary activity. N Engl J Med 332:351-355, 1995. van der Heijden G, Beurskens A, Koes BW et al. The efficacy of traction for back and neck pain: A systematic blinded review of randomized clinical trial methods. Phys Ther 75:93-104, 1995. Cherkin DC, Deyo RA, Loeser JD et al. An international comparison of back surgery rates. Spine 19:1201-1206, 1994. Lahad A, Malter ADF, Berg AO et al. The effectiveness of four interventions for the prevention of low back pain. JAMA 272:1286-1291, 1994. Turner EM, Ersek M, Herron L, et al. Patient outcomes after lumbar spine fusions. JAMA 268:907-911, 1992. Carette S, Marcoux S, Truchon R, et al. A controlled trial of corticosteroid injections into facet joints for chronic low back pain. N Engl J Med 325:1002-1007, 1991. Deyo RA, Walsh NE, Martin DC, et al. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med 322:1627-1634, 1990. Deyo R et al. How many days of bedrest for acute low back pain? A randomized clinical trial. N Engl J Med 315:1064-1070, 1986.

3/2016

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