Psychomotor Therapy as Complimentary Treatment to Patients With Shoulder Pain.

NCT ID: NCT02629783

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2017-09-01

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physiotherapy + Corticosteroid injection + Psychomotor therapy

Usual care + intervention

Group Type: EXPERIMENTAL

Psychomotor therapy

Intervention Type: OTHER

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.

Physiotherapy

Intervention Type: OTHER

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.

corticosteroid injection

Intervention Type: DRUG

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

Physiotherapy + Corticosteroid injection

Usual care

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

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.

corticosteroid injection

Intervention Type: DRUG

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

Interventions

Psychomotor therapy

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.

Intervention Type: OTHER

Physiotherapy

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: OTHER

corticosteroid injection

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lilli Soerensen, MD

Role: STUDY_CHAIR

Outpatient shoulder clinic, orthopaedic department at Hospital Lillebaelt - Vejle Hospital

Kim G. Ingwersen, PhD.Fellow

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation department at Hospital Lillebaelt - Vejle Hospital

Locations

Shoulder clinic, Orthopedic department, Hospital Lillebaelt - Vejle Hospital

Vejle, Jutland, Denmark

Countries

Denmark

References

Ingwersen KG, Vobbe JW, Pedersen LL, Sorensen L, Wedderkopp N. Effect of Psychomotricity in Combination With 3 Months of Active Shoulder Exercises in Individuals With Chronic Shoulder Pain: Primary Results From an Investigator-Blinded, Randomized, Controlled Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):2136-2143. doi: 10.1016/j.apmr.2019.05.032. Epub 2019 Jun 24.

Reference Type: DERIVED

PMID: 31247165 (View on PubMed)

Other Identifiers

S-20150111

Identifier Type: -

Identifier Source: org_study_id