Psychomotor Therapy as Complimentary Treatment to Patients With Shoulder Pain.

Shoulder Pain Clinical Trial

— PsychShoP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629783
• Other study ID #: S-20150111
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: November 1, 2017
• Start date: March 1, 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: November 2017
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• 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.
• 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.

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

Locations

Country	Name	City	State
Denmark	Shoulder clinic, Orthopedic department, Hospital Lillebaelt - Vejle Hospital	Vejle	Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life on "EQ-5D"	Patient reported generic quality of life outcome measure	Change from baseline EQ-5D at 12 weeks
Other	Quality of life on "EQ-5D"	Patient reported generic quality of life outcome measure	Change from baseline EQ-5D at 24 weeks
Other	Patient reported function and pain on the "Disability in the Arm, Shoulder and Hand (DASH) questionnaire"	Patient reported generic shoulder outcome questionnaire (questions upon function and pain related limitations).	Change from baseline DASH at 24 weeks
Primary	Patient reported function and pain on the "Disability in the Arm, Shoulder and Hand (DASH) questionnaire"	Patient reported generic shoulder outcome questionnaire (questions upon function and pain related limitations).	Change from baseline DASH at 12 weeks
Secondary	Hospital Anxiety and Depression score (HAD)	Patient reported generic mental outcome measure	Change from baseline HAD at 12 weeks
Secondary	Hospital Anxiety and Depression score (HAD)	Patient reported generic mental outcome measure	Change from baseline HAD at 24 weeks
Secondary	Pain on the NRS Scale	"Short Message Service" (SMS) is sent to the patients phone regarding pain.	Change from baseline NRS at weeks 1-24
Secondary	Multidimensional Assessment of Interoceptive Awareness (MAIA)	Patient reported generic body awareness outcome measure	Change from baseline MAIA at 12 weeks
Secondary	Multidimensional Assessment of Interoceptive Awareness (MAIA)	Patient reported generic body awareness outcome measure	Change from baseline MAIA at 24 weeks