Psychomotor Therapy as Complimentary Treatment to Patients With Shoulder Pain - a Randomized Controlled Trial.

Psychomotor Therapy as Complimentary Treatment to Patients With Shoulder Pain.

Sponsors

Lead sponsor: Vejle Hospital

Source Vejle Hospital
Brief 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.

Overall Status Completed
Start Date March 1, 2016
Completion Date September 1, 2017
Primary Completion Date September 1, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Patient reported function and pain on the "Disability in the Arm, Shoulder and Hand (DASH) questionnaire" Change from baseline DASH at 12 weeks
Secondary Outcome
Measure Time Frame
Hospital Anxiety and Depression score (HAD) Change from baseline HAD at 12 weeks
Hospital Anxiety and Depression score (HAD) Change from baseline HAD at 24 weeks
Pain on the NRS Scale Change from baseline NRS at weeks 1-24
Multidimensional Assessment of Interoceptive Awareness (MAIA) Change from baseline MAIA at 12 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA) Change from baseline MAIA at 24 weeks
Enrollment 88
Condition
Intervention

Intervention type: Other

Intervention name: Psychomotor therapy

Description: 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.

Arm group label: Physiotherapy + Corticosteroid injection + Psychomotor therapy

Intervention type: Other

Intervention name: Physiotherapy

Description: 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.

Intervention type: Drug

Intervention name: corticosteroid injection

Description: At baseline, patients with signs of inflammation in the subacromial bursa, can receive a ultrasound guided corticosteroid injection in the bursa

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Location
facility Shoulder clinic, Orthopedic department, Hospital Lillebaelt - Vejle Hospital
Location Countries

Denmark

Verification Date

November 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Physiotherapy + Corticosteroid injection + Psychomotor therapy

Arm group type: Experimental

Description: Usual care + intervention

Arm group label: Physiotherapy + Corticosteroid injection

Arm group type: Active Comparator

Description: Usual care

Acronym PsychShoP
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov