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Division of Geriatrics and Gerontology 黃黃黃 Effect of Physical Therapy on Pain and Function in Patients With Hip Osteoarthritis A Randomized Clinical Trial JAMA. 2014 May 21;311(19):1987-97.

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Division of Geriatrics and Gerontology黃柏誠

Effect of Physical Therapy on Pain and Function in Patients With Hip

OsteoarthritisA Randomized Clinical Trial

JAMA. 2014 May 21;311(19):1987-97.

2

Hip osteoarthritis

• Guideline

– for symptomatic hip osteoarthritis

• conservative non-pharmacological physiotherapy

• irrespective of severity, pain levels, and functional

status

Introduction

OARSI recommendations for the management of hip and knee osteoarthritisOsteoarthritis Cartilage. 2010;18(4):476-499.

3

Importance

• Physical therapy for hip osteoarthritis

– limited evidence of RCT

Introduction

4

ObjectiveIntroduction

Hip osteoarthritis

Pain Function

12-wks multimodal physical therapy

5

Design

• A randomized, participant- and assessor

blinded, parallel-group, placebo-controlled

trial

Methods

6

Setting

• Intervention: 12 wks

• Follow-up: 24 wks

Methods

7

Participants

• 102 volunteers recruited from the community

– May 2010 ~ April 2012

Methods

8

Participants

• Inclusion

– ≧50 y/o

– hip osteoarthritis confirmed by radiograph#

– hip pain for ≧3 months

– average pain intensity in past week ≧40/100mm

(VAS)

– moderate difficulty with daily activities

Methods

# The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991;34(5):505-514.

9

Participants

• Exclusion

– Regular structured exercise or walking

– Physical therapy, chiropractic treatment in

past 6 mo

– Hip surgery in past 6 mo or waiting list for hip

surgery

– Hip or knee replacement

– Corticosteroid use

– Inability to walk unaided

Methods

10

FlowchartMethods

1441 patients with hip OA

203 for X-ray

111 for physical screening

102 randomized

1238 Excluded  212 Did not meet inclusion criteria  982 Met exclusion criteria  44 Did not undergo X-ray

92 Excluded  51 Did not meet inclusion criteria  6 No longer interested  35 No longer eligible

9 Could not reproduce hip pain

11

RandomizationMethods

5349

102 randomized

Active Placebo

12

Schedule

• intervention: 10 sessions over 12 weeks

Methods

intervention

60min

30-45min

12

3 4 5 6 7 8 9 10

13

Active treatment (12 wks)

• manual therapy

– hip thrust manipulation

– hip lumbar spine mobilization

– deep tissue massage

– muscle stretches

Methods

12

3 4 5 6 7 8 9 10 intervention

14

Active treatment (12 wks)

• home exercise (4 times/wk)

– strengthening of the hip abductors and quadriceps

– stretching and range of motion

– functional balance and gait drills

Methods

12

3 4 5 6 7 8 9 10 intervention

15

Active treatment (12 wks)

• education and advice

– osteoarthritis

– response to exercise and daily physical activity

– activity-rest cycle versus over-activity cycle

– joint protection advice

Methods

12

3 4 5 6 7 8 9 10 intervention

16

Active treatment (12 wks)

• Prescription of a single walking stick

– only if it will enable the patient to improve their

gait pattern and increase their daily physical

activity

Methods

12

3 4 5 6 7 8 9 10 intervention

17

Placebo (12 wks)

• inactive ultrasound

• inert gel

Methods

12

3 4 5 6 7 8 9 10 intervention

18

Schedule

• intervention: 10 sessions over 12 weeks

Methods

12

3 4 5 6 7 8 9 10 intervention

19

Schedule

• intervention: 10 sessions over 12 weeks

• follow up: 24 weeks

Methods

follow up

12

3 4 5 6 7 8 9 10 intervention

20

Follow up (24 wks)

• active group

– home exercise (3 times/wk)

Methods

follow up

21

Follow up (24 wks)

• placebo group

– self-applied gel (3 times/wk)

Methods

follow up

22

OutcomesMethods

blinded assessor questionnaire

s

23

Primary outcomesResults

PrimaryPain

Function

Pain: VAS (0-100mm) (0: best)

Function: WOMAC (0-68) (0: best)Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1

24

OutcomesMethods

SecondaryPrimary

Impairments

Physical performance

Global change

Psychological status

Quality of life

Pain

Function

Pain

Function

Impairments

Physical performance

Global change

Psychological status

Quality of life

25

FlowchartResults

44

50

53

1441 patients with hip OA 1339

Excluded

96 (94%)

83 (81%)

49

46

39

102 randomized

Active Placebo

13 wk

36 wk

26

Characteristics

• similar at baseline

Results

27

Primary outcomesResults

PrimaryPain

Function

Pain: VAS (0-100mm) (0: best)

Function: WOMAC (0-68) (0: best)Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1

28

Pain: within-group

• both groups

– statistically significant improvements

Primary Outcome

Activemean [ 95% CI ] mm

Placebomean [ 95% CI ] mm

13 week−17.8 [−26.2,

−9.3]−23.6 [−31.4, −15.9]

29

Pain: between-groups

• not significantly different

– mean difference of 6.9 [−3.9, 17.7] in favor of

placebo

Primary Outcome

Activemean(SD) mm

Placebomean(SD) mm

Baseline 58.8 (13.3) 58.0 (11.6)

13 week 40.1 (24.6) 35.2 (21.4)

30

Function: within-group

• both groups

– statistically significant improvements

Primary Outcome

Activemean [ 95% CI ]

Placebomean [ 95% CI ]

13 week−4.5 [−8.5,

−0.4]−5.7 [−9.1,

−2.3]

31

Function: between-groups

• not significantly different

– mean difference of 1.4 [−3.8, 6.5] in favor of

placebo

Primary Outcome

Activemean(SD)

Placebomean(SD)

Baseline 32.3 (9.2) 32.4 (8.4)

13 week 27.5 (12.9) 26.4 (11.3)

32

Secondary outcomes

• no between-group differences

– except balance step test

Results

33

Adverse effects

• Significantly more participants in the active

group reported adverse events (p=0.003)

Results

Active Placebo

Participants 19 (41%) 7 (14%)

Eventsincreased hip painback painpain in other regionincreased stiffness

2615010802

96021

34

No additional benefits

• Both groups showed significant

improvements in pain and function following

treatment.

Discussion

35

Exercise & manual therapy

• Two randomized controlled trials in hip OA

– combining exercise and manual therapy

• does not confer additional benefits

• may have an adverse interaction effect

Discussion

Osteoarthritis Cartilage. 2013;21(4):525-534.Arch Phys Med Rehabil. 2013;94(2):302-314.

36

Strength

• minimized potential for bias

– a credible sham treatment

– concealing treatment allocation

– blinding (participants, assessor, biostatistician)

Discussion

37

Limitation

• lack of therapist blinding

• the absence of more blinding than expected

at the final follow-up assessment

• not all participants adhered fully to treatment

Discussion

38

Limitation

• the results cannot necessarily be generalized

– to different physical therapy programs

– to cohorts of younger patients

– to those with milder symptoms

Discussion

39

ConclusionSummary

Hip osteoarthritis

Pain Function

12-wks multimodal physical therapy

1) no additional benefit2) more adverse effects

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