Effectiveness of manual therapy with pragmatic physiotherapy for rotator cuff-related shoulder pain: a pilot randomized clinical trial.
Gisela Sole, Ari Samaranayaka, Christina Douglas and 5 others
Both groups improved on the shoulder disability score, and the gap between them stayed under the 11-point threshold set in advance.
This pilot confirms a full trial is workable but does not yet show whether manual therapy adds benefit.
Key findings
1Both groups improved on the QuickDASH from baseline to 3 months, and the between-group difference at every timepoint was below the 11-point non-inferiority margin, with no between-group differences based on the 95% confidence intervals.
2At 6 months the manual therapy group scored higher on the Pain Self-Efficacy Questionnaire (55.4 versus 48.9, a difference of 6.3 out of 60 points), the only secondary outcome showing a between-group difference.
3Retention was 93% at 3 months and 88% at 6 months, patient adherence to completing sessions was 87%, and fidelity for delivering or excluding manual therapy was 94% in both groups, all above the pre-set 80% feasibility threshold.
Still to come
How it was doneWhat they foundWhat it means for PTs
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What it does not show
Pilot study with 68 participants; the analyses are exploratory and not powered to detect clinically meaningful differences or to confirm non-inferiority. Patients and physiotherapists were unblinded to group allocation, so expectations could influence self-reported outcomes. Only 4 of 68 participants (6%) identified as Māori or Pasifika despite preferential recruitment, limiting generalisability to those communities. Diary return rate was 72%, so home exercise, medication use, and other healthcare access were incompletely captured. One physiotherapist inadvertently delivered manual therapy to two participants in the no-manual-therapy group, and the project manager had access to the allocation list, weakening allocation concealment. The person-centred communication ratings ranged widely (10% to 100%), suggesting inconsistent delivery of the intended communication style across therapists.
Declared interests
No conflicts of interest declared. Funded by a Stanley Paris Fellowship; the funder was not involved in study design, data collection, analysis, interpretation, or drafting.
The easy way to misread this
Do not read the 6.3-point Pain Self-Efficacy difference at 6 months as evidence that manual therapy improves pain confidence — it is the single exploratory secondary outcome in a 68-person pilot, and the primary outcome (shoulder disability) showed no between-group difference at any timepoint. The study was designed to test feasibility, not to prove or disprove the added value of manual therapy.
Summarised by AI from the full paper, without a clinician reviewing it. Check it against the source before it changes what you do. Read it on PubMed →