Effects of Movement Representation Techniques with Sensorimotor Training for Rotator Cuff Related Shoulder Pain

NCT06823206 | Not Yet Recruiting

• 1 other identifier: HSEARS20231205001
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rotator Cuff Related Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  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 Outcomes (1)

• Cortical thickness in the primary motor cortex (M1) using brain MRI

  Baseline and 12 weeks post-intervention

Other Outcomes (5)

• Shoulder strength

  Baseline and 12-weeks post-intervention

• Subacromial space

  Baseline and 12-weeks post-intervention

• Central pain processing

  Baseline and 12-weeks post-intervention

Study Arms (2)

Control

NO INTERVENTION

Wait-list control

Intervention

EXPERIMENTAL

Other: Sensorimotor training with movement representation techniques

Interventions

Sensorimotor training with movement representation techniques OTHER

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.

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Central Study Contacts

Annie LEONG

CONTACT

85227666707; annie-ht.leong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 12, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-01