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NCT Number: NCT06823206

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annie LEONG

CONTACT

[email protected]

85227666707

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Effects of Movement Representation Techniques with Sensorimotor Training for Rotator Cuff Related Shoulder Pain: a Randomised Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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