Background
Primary hypothesis
Secondary hypotheses
Methods
Trial design
Participants
Procedure
Randomisation and allocation concealment
Blinding
Interventions
Active Physiotherapy Overview | Sham Physiotherapy Overview |
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Session 1 (45-60 mins)
• Subjective and objective assessment (20-25 mins) • Patient education (5 mins) • 2 of the mandatory manual therapy techniques (5-10 mins) • Teach hip abduction and knee extension strengthening home exercises (15-20 mins) |
Session 1 (45-60 mins)
• Subjective and objective assessment (20-25 mins) • Patient education (5 mins) • Information about gel and application (5-10 mins) • Information about pulsed ultrasound and application (10 mins) • Discuss log-book and attendance (5-10 mins) |
Session 2 (45-60 mins)
• Subjective and objective re-assessment (10 mins) • Patient education (5-10 mins) • 2-4 of the mandatory manual therapy techniques (15-20 mins) • Teach all mandatory home exercises and check log-book (15-20 mins) |
Session 2 (45-60 mins)
• Subjective and objective re-assessment (23 mins) • Application of sham gel (10-15 mins) • Application of sham pulsed ultrasound (10-15 mins) • Check and discuss log-book (2-7 mins) |
Session 3-10 (30 mins)
• Subjective and objective re-assessment (5 mins) • All mandatory manual therapy techniques with addition of optional techniques if justified (15 mins) • Progress all mandatory home exercises, addition of optional exercises if justified and check log-book (10 mins) |
Session 3-10 (30 mins)
• Subjective and objective re-assessment (13 mins) • Application of sham gel (7 mins) • Application of sham pulsed ultrasound (8 mins) •Check log-book (2 mins) |
Follow-up period
• 5 home exercises 3 times/week |
Follow-up period
• Self-application of gel 3 times/week |
Active physiotherapy
Manual Therapy Techniques | Description | Dosage |
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Mandatory techniques:
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Long axis distraction with thrust | Supine. The hip is in 15-30° flexion, 15-30 ° AB, slight ER. Preferably use seat belt. Perform 3-6 thrusts at the beginning of the first set then perform oscillations in the remaining sets. | 3-6 sets of 30 secs |
Seatbelt glide, or distraction mobilisations, with the hip flexed | Supine with hip flexed and using a seatbelt, oscillatory passive accessory mobilisation forces applied caudally or laterally to the proximal thigh. | 3-6 sets of 30 secs |
Internal rotation in prone | Prone with knee flexed. IR until contralateral pelvis rises, apply oscillatory force downwards to contralateral pelvis. | 3-6 sets of 30 secs |
Soft-tissue or deep-tissue massage of quads, adductors, hamstrings, psoas, lateral hip muscles and/or posterior hip muscles and associated fascia | Firm effleurage stroke, deep frictions or sustained pressure trigger point release with the muscle on stretch. | 2-5 mins |
Optional techniques:
| ||
Long axis distraction in prone | Prone. The hip is in 10-15 ° AB. Preferably use seat belt. Perform caudally directed oscillations. May perform 3-6 thrusts at the beginning of the first set. | 3-6 sets of 30 secs |
Antero-posterior progression (posterior glide) | Supine with hip in flexion and adduction. Use body weight to impart passive oscillations to the postero-lateral hip capsule through the long axis of the femur. Add more flexion, adduction, &/or internal rotation to progress. | 3-6 sets of 30 secs |
Postero-anterior progression (anterior glide) | Prone with knee bent. Leg supported at knee (may use seatbelt). Pressure applied inferior and medial to greater trochanter in posterior to anterior direction. Vary amount of hip flexion/extension, AB/AD, IR/ER. Modify to use figure-4 position and apply pressure through sacrum. | 3-6 sets of 30 secs |
Manual stretches to one joint knee extensors, rectus femoris, hip flexors, hamstrings, hip internal rotators, hip external rotators, or hip adductors | Stretch should be felt in target muscle. Manual stretches should match the soft or deep tissue massage technique selected. | 6 reps × 20 secs or 4 × 30 secs or 2 × 60 secs |
Lumbar spine mobilisation | - Unilateral postero-anterior accessory glides - Passive physiological lumbar spine rotation - Lumbar spine manipulation (supine) - Lumbar spine manipulation (side lying with affected hip up) | 3-6 sets of 30 secs |
Home exercises
|
Description
|
Dosage
|
Mandatory techniques:
|
[Exercise difficulty must be progressed]
| |
Hip abductor strengthening | Progressed through supine, standing, side lying and standing wall press. | 3 × 10 repetitions |
Quads strengthening exercise | Progressed through sitting elastic band press or knee extension, partial squats, partial wall squats*, sit-to stand* and split sit to stand. | 3 × 10 repetitions |
Muscle stretch (should match with the soft tissue/deep tissue massage technique chosen in the manual therapy section | - Hip extension - Hip flextion - Hip abduction and external rotation - Hip internal rotation | 2 mins total with 20-60 sec hold times |
Challenging functional neuromuscular balance/gait drills set | - standing weight shifting forwards#, lateral# and tandem stance#
- standing hip control progressing to eccentric hip abductor exercise - balance in double leg stance on foam# or single leg stance#
- side stepping progressing to 'carioca' (or braiding) - shuttle walking - stairs | 1-2 exercises (4 minutes total time) |
Optional techniques:
|
[Maximum of two]
| |
Strengthening exercise(s) | - hip extensors progressed through gluteal sets, bridging* and unilateral bridging - hip external rotators progressed through clamshells (or sitting or 4-point kneeling internal rotation), resisted clamshells (or sitting internal rotation) and standing wall press - hip internal rotators progressed through 4-point kneeling, sitting and bottom-leg clamshells | 3 × 10 repetitions |
Additional stretches(s) | (as above) | |
Lumbopelvic control exercise | Supine pelvic tilt with progressions | 10 repetitions |
* Option to add elastic band resistance around both knees.
# Option to close eyes. | ||
Patient education
| ||
- About osteoarthritis - Response to exercise and daily physical activity - Activity-rest cycle versus over-activity cycle - Joint protection advice | ||
Prescription of a single walking stick
| Only if it will enable the patient to improve their gait pattern and increase their daily physical activity. | |
Stationary cycling
| Up to 10 minutes at a moderate level of intensity (rated as "hard" up to "very hard" - level 5-8 on the Modified Borg Rating Scale of Perceived Exertion achieved within 2 minutes of activity if possible) after each treatment session while at the physiotherapy clinic. |
Sham physiotherapy
Follow-up period
Outcome measures
Primary outcome measures
Primary outcome measures | Data collection instrument | Collection points |
---|---|---|
Average pain in past week | 100 mm VAS | 0, 13, 36 weeks |
Physical function in past 48 hours | WOMAC Osteoarthritis Index 3.1 Likert version | 0, 13, 36 weeks |
Secondary outcome measures
| ||
Pain, function, and stiffness | HOOS (incorporating WOMAC) | 0, 13, 36 weeks |
Health-related quality of life | Assessment of Quality of Life Instrument version 2 (AQoL II) | 0, 13, 36 weeks |
Patient's global rating of change overall and for pain and function | 7-point ordinal scale | 13, 36 weeks |
Self efficacy | Arthritis Self-efficacy scale | 0, 13, 36 weeks |
Pain catastrophizing | Pain Catastrophizing Scale | 0, 13, 36 weeks |
Coping strategies | Coping Strategies questionnaire | 0, 13, 36 weeks |
Objective functional performance | Timed 40 m walk Timed stair climb (ascent and descent) 30 second sit-to-stand | 0, 13 weeks |
Standing balance | Step test 4-square step test | 0, 13 weeks |
Hip range of motion | Clinical methods and inclinometer | 0, 13 weeks |
Hip and knee muscle strength | Isometric - isokinetic dynamometer (quadriceps and hamstrings) and instrumented manual muscle tester (hip flexors, extensors, abductors, rotators) | 0, 13 weeks |
Gait biomechanics (in a subset) | 3-dimensional motion analysis system | 0, 13 weeks |
Other measures
| ||
Physical activity levels | Physical Activity Scale for the Elderly (PASE) Pedometer worn for 7 days | 0, 13, 36 weeks |
Treatment credibility | Treatment Credibility Scale | 1,12 weeks |
Participant success of blinding | Questionnaire | 13, 36 weeks |
Healthcare consumption and related costs | Questionnaire; health system records | 0, 5, 9, 13, 36 weeks |
Adverse events | Participant log-book | Throughout |
Adherence - treatment session attendance; home exercise or gel application | Participant log-book; Therapist treatment records; Questionnaire | Throughout |