Psychomotor Therapy as Complimentary Treatment to Patients With Shoulder Pain.

Study design:

This trial, is a randomised, controlled, observer-blinded superiority trial, with a two-group parallel design, to be conducted in Denmark. The primary endpoint will be 12 weeks after baseline. Patients will be randomised to either "Intervention+Usual Care" or "Usual Care" (block randomization with a 1:1 allocation).

Settings and locations:

Patients will be recruited from the shoulder unit at the outpatient clinic, orthopaedic department at Hospital Lillebaelt - Vejle Hospital.

Randomisation and allocation concealment:

Patients will be randomly assigned to either of the two groups with a 1:1 allocation as per a computergenerated randomisation schedule, stratified by administration of concomitant corticosteroid injection using permuted blocks of random sizes (two to six). The primary investigator, assessors and administrator of the randomisation procedure will not know block sizes in order to ensure allocation concealment

Blinding:

Outcome assessors will perform both baseline and followup assessments, and will be kept blinded from treatment allocation. At the follow-up assessments, patients will be strongly encouraged not to disclose the components of their intervention programme, in order to keep the outcome assessor blinded.

Statistical analysis plan:

The primary efficacy analysis performed is assessment of the between-group difference in change in the DASH score after 12 weeks in the intent-to-treat (ITT) population (all randomised patients independent of compliance and withdrawals). In the case of missing data due to dropouts, a non-responder imputation will be applied; a baseline observation carried forward (BOCF) technique will be used for patients who do not complete the study. For the primary analyses at week 12, we will use analysis of covariance (ANCOVA) to compare the progressive high-load exercise group with the low-load exercise group for mean changes from baseline in the DASH score, as well as the secondary continuous outcomes. The primary model includes the change from baseline as the dependent variable, with treatment group (Intervention OR Usual care), corticosteroid status (yes or no) as main effects, with the baseline score as an additional covariate.

To analyse the longitudinal element of time effects of NRS in the randomized trial (repeated measures design 1-24 weeks), a linear approach will be used, fitted in SAS software (version 9.3 Service Pack 4; SAS Institute Inc., Cary, North Carolina, United States) using the procedure 'PROC MIXED' based on restricted maximum likelihood (REML) estimates of the parameters. The variable 'patient' will be applied as a random effects factor. Assessment of the treatment and time effects is of exploratory interest for the primary outcome in testing for a possible interaction, and both treatment and time will be used as systematic factors, using the baseline value as covariate to reduce random variation and increase power.

Inclusion criteria

• >three months of should pain
• Disturbed sleep due to shoulder pain
• VAS resting pain above 2 OR VAS activity pain above 5
• MAIA score <= 3
• Read and understand Danish.

Exclusion criteria

• Frozen shoulder
• Glenohumeral (GH) arthritis
• Rotator Cuff (RC) rupture
• GH instability
• Acromioclavicular joint arthritis
• Operation in the shoulder joint within the last six months
• Cervical problems
• Psychiatric diagnosis
• Alcohol or drug abuse