Rotator Cuff SyndromeNCT07656441
Mobilization With Movement in Rotator Cuff Tendinopathy
A study testing Exercise Therapy and Mobilization With Movement (MWM) in people with Rotator Cuff Syndrome, run by Kirsehir Ahi Evran Universitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- Exercise Therapy and Mobilization With Movement (MWM)
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2026to 13 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
About this study
Official title: Effects of Mobilization With Movement on Tendon Morphology, Pain, and Function in Patients With Rotator Cuff Tendinopathy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- Exercise Therapy, Mobilization With Movement (MWM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyBehavioural
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)
Mobilization With Movement (MWM)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise Therapy; Procedure: Mobilization With Movement (MWM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Secondary outcomes (9)
Pain Intensity
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). Participants will rate their pain at rest, during activity, and at night. Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Shoulder Pain and Disability Index (SPADI)
SPADI will be used to evaluate shoulder pain and functional disability. The questionnaire consists of pain and disability subscales, with total scores ranging from 0 to 100. Higher scores indicate greater disability.
Measured: Baseline (Week 0) and post-intervention (Week 8)
QuickDASH Score
QuickDASH will assess upper limb disability and symptoms. It consists of 11 items scored from 1 to 5, converted to a scale from 0 to 100. Higher scores indicate greater functional limitation.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Shoulder Range of Motion (ROM)
Active shoulder flexion, abduction, internal rotation, and external rotation will be measured using a goniometer or digital inclinometer in degrees.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Shoulder Muscle Strength
Isometric muscle strength of shoulder abductors and external rotators will be measured using a handheld dynamometer. Results will be recorded in Newtons (N).
Measured: Baseline (Week 0) and post-intervention (Week 8)
Joint Position Sense (JPS)
Shoulder proprioception will be assessed using a laser pointer method. The participant will attempt to reproduce a target shoulder flexion position with eyes closed. Deviation from the target position will be recorded in centimeters. Higher values indicate poorer proprioception.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Tampa Scale of Kinesiophobia (TSK)
TSK will be used to assess fear of movement and reinjury. The scale consists of 17 items scored on a 4-point Likert scale. Total scores range from 17 to 68, with higher scores indicating greater fear of movement.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Pain Catastrophizing Scale (PCS)
PCS measures exaggerated negative cognitive responses to pain, including rumination, magnification, and helplessness. It consists of 13 items with a total score ranging from 0 to 52. Higher scores indicate greater catastrophizing.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Central Sensitization Inventory (CSI)
CSI is a 25-item questionnaire assessing symptoms related to central sensitization. Total scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom severity.
Measured: Baseline (Week 0) and post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start8 Jul 2026 (estimated)
- Primary completion12 Dec 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
- Investigators
- Ömer ÖZÇELEP, Assist. Prof., Study director, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656441
- Sponsor's protocol ID
- KAEÜFTR
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobilization With Movement on Tendon Morphology, Pain, and Function in Patients With Rotator Cuff Tendinopathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07656441
- Acronym / sponsor ID
- KAEÜFTR
- Conditions
- Rotator Cuff Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 8 Jul 2026 (estimated)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Exercise Only Group | Active comparator | Behavioral: Exercise TherapyParticipants will receive a standardized shoulder exercise program focusing on rotator cuff strengthening, scapular stabilization, stretching, and range of motion exercises. |
| Exercise + Mobilization With Movement (MWM) Group | Experimental | Behavioral: Exercise Therapy, Procedure: Mobilization With Movement (MWM)Participants will receive the same standardized exercise program in addition to glenohumeral joint Mobilization With Movement (MWM) techniques. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TherapyA 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) | Behavioural | Exercise + Mobilization With Movement (MWM) Group, Exercise Only Group |
| 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 | Procedure or surgery | Exercise + Mobilization With Movement (MWM) Group |
Primary outcome
Supraspinatus Tendon Thickness
Time frame: Baseline (Week 0) and post-intervention (Week 8)
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.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ömer ÖZÇELEP, Assist. Prof. study director
Kirsehir Ahi Evran Universitesi
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy and Mobilization With Movement (MWM) in people with Rotator Cuff Syndrome, run by Kirsehir Ahi Evran Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supraspinatus Tendon Thickness (time frame: Baseline (Week 0) and post-intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.