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
PMID 42370335WHAT IT FOUND
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
01Both 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.
02At 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.
03Retention 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.