Methods | Randomised, placebo‐controlled, participant‐ and assessor‐blinded trial. | |
Participants |
Inclusion criteria: aged ≥ 50 years, hip OA fulfilling ACR classification criteria, pain in groin/hip for > 3 months, mean pain intensity in past week of ≥ 40 on 100 mm VAS, at least moderate difficulty with daily activities. Exclusion criteria: hip or knee joint replacements or both; planned lower limb surgery, physical therapy, chiropractic treatment or prescribed exercises for hip, lumbar spine or both in the past 6 months; walking continuously > 30 minutes daily; regular structured exercise more than once weekly. Sample size: 102; 96 completed intervention, 83 completed follow‐up. IG (n = 49): mean age 64.5 years; CG (n = 53): mean age 62.7 years. Country: Australia. |
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Interventions |
Providers: 8 physical therapists with ≥ 5 years of clinical experience and postgraduate qualifications. Training: yes. Setting: private clinic. Content: semi‐standardised exercises with core components and exercises depending on assessment. Participants given manual therapy techniques and 4‐6 home exercises to perform 4 times a week including strengthening, flexibility and balance exercises. Length/intensity: 10 individual treatment sessions over 12 weeks: 2 sessions in week 1, then once weekly for 6 weeks, then approximately once per fortnight. First 2 sessions were 45‐60 minutes, subsequent sessions were 30 minutes. Control: sham intervention of inactive ultrasound and inert gel applied to hip. No exercise or manual therapy instructions. During follow‐up phases, participants asked to apply gel for 5 minutes 3 times a week. |
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Outcomes |
Musculoskeletal impairments and functional performance tests at baseline and week 13:
Outcomes at 13 and 36 weeks: Primary:
Secondary:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers table, results placed in sealed envelopes by independent person. |
Allocation concealment (selection bias) | Low risk | Opened by another independent person 1 by 1, shortly before the next participant attended, and allocation result emailed to non‐blinded therapist. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | IG delivered by non‐blinded therapist: authors acknowledged non‐blinding of therapists was a weakness. Blinding of participants was low risk: checked with James test. Participants informed that the comparison was between physical intervention and sham physical therapy intervention but not what either consisted of. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor and biostatistician blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition: 6 (5.9%) completed did not complete the intervention in both groups and 19 (18.6%) did not complete follow‐up. |
Selective reporting (reporting bias) | Low risk | Results reported for all measures. |
Other bias | Low risk |