Psychomotor Therapy as Complimentary Treatment to Patients With Shoulder Pain.
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Some patients with shoulder pain have decreased body awareness (BA). To some degree, pain
      among these patients can be increased due to their lack in BA. Psychomotor therapy is thought
      to improve BA and thereby increase the effect of traditional therapy, such as physiotherapy
      and exercises.

      The aim of this study is therefore to investigate if psychomotor therapy, as a complimenting
      treatment to physiotherapy, decreases shoulder patients' function deficits and pain reported
      on PRO's, compared to physiotherapy alone.
    

Detailed description: 
      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.
    

Intervention name(s): Psychomotor therapy; Physiotherapy; corticosteroid injection
Intervention type(s): Other; Other; Drug
Intervention description(s): 1 treatment of approximately 45 minutes the first 5 weeks after randomization. The treatment will focus on teaching the patients about body awareness and handling of there shoulder problems in daily living.; Patients are, in secondary care setting, given 3-5 basic physiotherapy exercises for there shoulder pain, targeting rotator cuff muscles and scapula thoracic muscles. Furthermore they are given advice on seeking further physiotherapy guidance in private setting.; At baseline, patients with signs of inflammation in the subacromial bursa, can receive a ultrasound guided corticosteroid injection in the bursa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment