- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06823206
Effects of Movement Representation Techniques with Sensorimotor Training for Rotator Cuff Related Shoulder Pain
February 7, 2025 updated by: LEONG Hio Teng Annie, The Hong Kong Polytechnic University
Effects of Movement Representation Techniques with Sensorimotor Training for Rotator Cuff Related Shoulder Pain: a Randomised Controlled Trial
The aim of this study is to evaluate the efficacy of 12 weeks of sensorimotor training with movement representation techniques for reducing pain intensity in people with rotator cuff related shoulder pain, relative to standard care.
Besides, the secondary aim of this study is to explore the mechanisms underlying the effects of central mechanism treatment in people with rotator cuff related shoulder pain.
A total of 122 older adults aged 50 or above with the presence of shoulder pain for more than three months will be recruited and randomized into 12-weeks of movement representation techniques with sensorimotor training vs. standard care.
Shoulder pain and disability Index (SPADI), changes in primary motor cortex (M1) using brain MRI, changes in subacromial space using ultrasound imaging, Widespread Pain Index (WPI), Pain Catastrophising Scale (PCS), and Fear-avoidance Beliefs questionnaires (FABQ) will be assessed at baseline and 12-week post intervention.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
122
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annie LEONG
- Phone Number: 85227666707
- Email: annie-ht.leong@polyu.edu.hk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 50 or above
- Presence of shoulder pain for more than three months
- Clinical test showed 3/5 positive tests (painful arc, resisted external rotation, Neer test, Kennedy-Hawkins test, and Jobe test), and the intensity of pain being provoked should be ≥ 3/10 on an 11-point numeric pain rating scale (NPRS)
- Structural changes of rotator cuff tendons using MRI or ultrasound imaging
Exclusion Criteria:
- History of trauma
- Shoulder fracture, glenohumeral osteoarthritis, or arthritis in the acromioclavicular joint
- Clinically suspected labrum lesion
- Previous shoulder surgery or dislocation
- Clinical signs of anterior shoulder instability
- Clinical signs of frozen shoulders
- Previous clinical treatment or corticosteroid injection for a shoulder injury within the last 12 months
- Symptoms referred from or related to the spine; and (9) other competing diagnoses (i.e., rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, or psychiatric illness).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
Sensorimotor training will be implemented with movement representation techniques using a standardized retraining sequence of a shoulder control exercise during arm elevation with 3 phases: Phase 1: Action Observation Training; Phase 2: Mirror therapy; and Phase 3: Sensorimotor training of the involved arm.
Each session will last 60 minutes, with one supervised intervention session over the 12 weeks.
|
|
No Intervention: Control
Wait-list control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Baseline and 12-weeks post-intervention
|
Pain will be assessed using the pain sub-score of the Chinese Version of the Shoulder Pain and Disability Index.
It is a validated self-administered questionnaire used to evaluate upper limb symptoms and functional limitations during daily activities.
The questionnaire consists of 13 items with two subscales, i.e., pain intensity (five items) and disability (eight items), and each subscale-item will be summed to obtain a pain-score and a disability-score.
The total of all items will be summed to obtain the final scores for each domain ranging from 0 to 100, with higher scores indicating more pain and disability.
In the present study, the pain sub-score will be used as the measure of average pain intensity.
|
Baseline and 12-weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortical thickness in the primary motor cortex (M1) using brain MRI
Time Frame: Baseline and 12 weeks post-intervention
|
The brain structure will be measured using structural and resting-state functional magnetic resonance imaging (fMRI) on a 3.0 T Siemens Prisma scanner.
During the resting-state scan, the participants will be instructed to rest with their eyes closed while remaining stationary for 30 minutes.
The regional cortical thickness of the brain region, the primary motor cortex (M1), will be extracted from T1-weighted MRI images.
|
Baseline and 12 weeks post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder strength
Time Frame: Baseline and 12-weeks post-intervention
|
The isokinetic testing of shoulder rotational strength will be measured using a Cybex Norm isokinetic dynamometer
|
Baseline and 12-weeks post-intervention
|
|
Subacromial space
Time Frame: Baseline and 12-weeks post-intervention
|
The subacromial space will be scanned using an ultrasound scanning system during arm resting at 0° and static arm holding at 60° of shoulder abduction.
The subacromial space will be measured from the tangential distance between the humeral head and the infero-lateral edge of the acromion.
Three measurements will be recorded and the averaged value will be calculated.
|
Baseline and 12-weeks post-intervention
|
|
Central pain processing
Time Frame: Baseline and 12-weeks post-intervention
|
The Widespread Pain Index will be adopted to capture features of central sensitisation.
It quantifies the extent of bodily pain on a 0-19 scale, assessing whether patients have pain in 19 different body regions, each point scores 1.
All items will be summed to obtain a final score ranging from 0 to 100, with higher scores indicating more widespread pain.
|
Baseline and 12-weeks post-intervention
|
|
Pain Catastrophising
Time Frame: Baseline and 12-weeks post-intervention
|
The Chinese version of the Pain Catastrophising Scale will be used to assess pain catastrophising.
This is a validated self-administered questionnaire consisting of 13-items examining pain-related behaviours and cognition.
Scores range from 0 to 52, with higher scores indicating a higher level of catastrophising.
|
Baseline and 12-weeks post-intervention
|
|
Fear-avoidance Beliefs questionnaires
Time Frame: Baseline and 12-weeks post-intervention
|
The Chinese version of the Fear-avoidance Beliefs questionnaires is a self-administered questionnaire consisting of 16 items with 2 subscales that evaluate fear avoidance beliefs about physical activity and work.
Each item is scored from 0 to 6, representing completely disagree to completely agree.
The total score is calculated by the summation of the individual scores of each item, from 0 to 96, with higher scores indicating a higher degree of fear avoidance belief.
|
Baseline and 12-weeks post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
January 9, 2025
First Submitted That Met QC Criteria
February 7, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 7, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20231205001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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