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Not yet recruiting NCT07656441

Mobilization With Movement in Rotator Cuff Tendinopathy

No phase Interventional Rotator Cuff Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise Therapy, Mobilization With Movement (MWM).
Who it may be relevant to
Registry conditions: Rotator Cuff Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Mobilization With Movement on Tendon Morphology, Pain, and Function in Patients With Rotator Cuff Tendinopathy: A Randomized Controlled Trial

Overview

This randomized controlled trial aims to investigate the effects of Mobilization With Movement (MWM) combined with exercise therapy on tendon morphology, pain, and functional outcomes in individuals with rotator cuff tendinopathy. A total of approximately 60 participants diagnosed with supraspinatus tendinopathy will be randomly assigned to either an exercise-only group or an exercise plus MWM group. All participants will undergo a standardized rehabilitation program for 8 weeks. Clinical outcomes, including pain intensity (Visual Analog Scale), shoulder function (SPADI and QuickDASH), range of motion, muscle strength, proprioception, and psychosocial status (Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, and Central Sensitization Inventory), will be assessed at baseline and post-intervention. In addition, ultrasound imaging will be used to evaluate tendon morphology, including tendon thickness, subacromial bursa thickness, acromiohumeral distance, echogenicity, and vascularity. The primary objective is to determine whether MWM produces superior improvements in clinical outcomes and whether it is associated with measurable changes in tendon structure as assessed by ultrasound. The findings are expected to contribute to a better understanding of the biomechanical and neurophysiological mechanisms underlying manual therapy in rotator cuff tendinopathy and to provide evidence for its role in musculoskeletal rehabilitation.

Detailed description

Rotator cuff tendinopathy is one of the most common causes of shoulder pain and functional limitation, often resulting in reduced quality of life and impaired upper extremity performance. Although exercise therapy is widely accepted as the cornerstone of conservative management, the additional benefit of manual therapy techniques, particularly Mobilization With Movement (MWM), remains an area of ongoing investigation. Furthermore, the potential effects of manual therapy on tendon morphology assessed via ultrasound imaging are not yet fully understood.

This randomized controlled trial will examine whether the addition of MWM to a standardized exercise program provides superior outcomes compared to exercise alone in individuals with supraspinatus tendinopathy. Participants will be randomly allocated into two groups: an exercise-only group and an exercise plus MWM group. Both interventions will be delivered over an 8-week period.

The study will focus on both clinical and imaging-based outcomes. Clinical outcomes include pain intensity, shoulder function, range of motion, muscle strength, proprioception, and psychosocial factors such as fear of movement, pain catastrophizing, and central sensitization. Imaging outcomes will be assessed using musculoskeletal ultrasound to evaluate tendon thickness, subacromial bursa thickness, acromiohumeral distance, echogenicity, and vascularity.

The primary aim is to determine whether MWM induces superior improvements in pain and function and whether these changes are accompanied by measurable alterations in tendon morphology. Secondary aims include exploring the relationship between ultrasound-based structural changes and clinical outcomes, as well as evaluating the potential role of psychosocial factors in treatment response.

This study is expected to provide new evidence regarding the structural and functional effects of manual therapy in rotator cuff tendinopathy and to clarify whether improvements in clinical symptoms are associated with objective changes in tendon morphology.

Interventions

  • Behavioral Exercise Therapy
    A standardized physiotherapy program including rotator cuff strengthening exercises, scapular stabilization exercises, posterior capsule stretching, pectoralis minor stretching, and active range of motion exercises for the shoulder.3 sessions per week for 8 weeks (supervised and/or home-based depending on protocol design)
  • Procedure Mobilization With Movement (MWM)
    Glenohumeral joint Mobilization With Movement techniques (Mulligan concept), including posterior glide and inferior glide techniques applied during active shoulder movement, aimed at improving pain-free range of motion and function. Application Details: Grade: Sustained glide during active movement Techniques: Posterior glide, inferior glide Dosage: 2 sessions per week for 8 weeks Performed by licensed physiotherapist

Primary outcome measures

  • Supraspinatus Tendon Thickness [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
Secondary outcome measures (9)
  • Pain Intensity [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
  • Shoulder Pain and Disability Index (SPADI) [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
  • QuickDASH Score [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
  • Shoulder Range of Motion (ROM) [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
  • Shoulder Muscle Strength [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
  • Joint Position Sense (JPS) [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
  • Tampa Scale of Kinesiophobia (TSK) [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
  • Pain Catastrophizing Scale (PCS) [Time frame: Baseline (Week 0) and post-intervention (Week 8)]
  • Central Sensitization Inventory (CSI) [Time frame: Baseline (Week 0) and post-intervention (Week 8)]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 65 years
  • Clinical diagnosis of rotator cuff tendinopathy (supraspinatus involvement) confirmed by musculoskeletal ultrasound
  • Shoulder pain duration of at least 3 months
  • Pain intensity ≥ 3/10 on the Visual Analog Scale (VAS)
  • Ability to understand and follow instructions and complete questionnaires

Exclusion criteria

  • Full-thickness or large rotator cuff tear confirmed by ultrasound or MRI
  • History of shoulder surgery on the affected side
  • Diagnosis of adhesive capsulitis (frozen shoulder)
  • Shoulder instability or dislocation history
  • Cervical radiculopathy or referred neck-related shoulder pain
  • Inflammatory rheumatic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis)
  • Neurological disorders affecting upper extremity function
  • Corticosteroid injection in the shoulder within the last 6 months
  • Ongoing physiotherapy or manual therapy treatment for shoulder pain in the last 3 months
  • Severe systemic or psychiatric conditions that may interfere with participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07656441 · KAEÜFTR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗