NCT07656441

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

June 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

July 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2026

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 15, 2026

Last Update Submit

June 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Supraspinatus Tendon Thickness

    Supraspinatus tendon thickness will be measured using musculoskeletal ultrasound imaging. Measurements will be obtained at the tendon footprint in the longitudinal plane using a high-frequency linear transducer. Tendon thickness will be recorded in millimeters (mm). This variable is selected as the primary structural outcome to evaluate morphological changes associated with the intervention. Increased or decreased tendon thickness will be interpreted in relation to clinical improvement and tissue remodeling.

    Baseline (Week 0) and post-intervention (Week 8)

Secondary Outcomes (9)

  • Pain Intensity

    Baseline (Week 0) and post-intervention (Week 8)

  • Shoulder Pain and Disability Index (SPADI)

    Baseline (Week 0) and post-intervention (Week 8)

  • QuickDASH Score

    Baseline (Week 0) and post-intervention (Week 8)

  • Shoulder Range of Motion (ROM)

    Baseline (Week 0) and post-intervention (Week 8)

  • Shoulder Muscle Strength

    Baseline (Week 0) and post-intervention (Week 8)

  • +4 more secondary outcomes

Study Arms (2)

Exercise Only Group

ACTIVE COMPARATOR

Participants will receive a standardized shoulder exercise program focusing on rotator cuff strengthening, scapular stabilization, stretching, and range of motion exercises.

Behavioral: Exercise Therapy

Exercise + Mobilization With Movement (MWM) Group

EXPERIMENTAL

Participants will receive the same standardized exercise program in addition to glenohumeral joint Mobilization With Movement (MWM) techniques.

Behavioral: Exercise TherapyProcedure: Mobilization With Movement (MWM)

Interventions

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)

Exercise + Mobilization With Movement (MWM) GroupExercise Only Group

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

Exercise + Mobilization With Movement (MWM) Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise TherapyMovement

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ömer ÖZÇELEP, Assist. Prof.

    Kirsehir Ahi Evran Universitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the interventions, participants and care providers cannot be blinded to group allocation. However, outcome assessments will be performed by an independent assessor who is blinded to group assignment. The assessor will not be involved in the treatment process or randomization procedures. This single-blind design is used to minimize assessment bias in both clinical and ultrasound-based outcome measures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is designed as a two-arm, parallel-group, randomized controlled interventional trial. Participants diagnosed with rotator cuff tendinopathy will be randomly allocated into either an exercise-only group or an exercise plus Mobilization With Movement (MWM) group. The intervention will be delivered over an 8-week period, and both groups will receive standardized exercise therapy. The experimental group will additionally receive MWM techniques applied to the glenohumeral joint. Outcomes will be assessed at baseline and immediately after the intervention period. The study follows a superiority framework, aiming to determine whether the addition of MWM provides greater improvements in tendon morphology (as assessed by ultrasound imaging), pain intensity, shoulder function, range of motion, muscle strength, proprioception, and psychosocial variables compared to exercise therapy alone. Randomization will be performed using a computer-generated sequence, and outcome assessors will
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 18, 2026

Study Start

July 8, 2026

Primary Completion (Estimated)

December 12, 2026

Study Completion (Estimated)

December 13, 2026

Last Updated

June 18, 2026

Record last verified: 2026-06