- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383038
Effect of Mobilization With Movement in Patients With Rotator Cuff Lesions
The Effect of Mobilization With Movement on Function, Disability, and Pain in Patients With Rotator Cuff Lesions: A Double-Blind Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of Mobilization with Movement (MWM) on pain and functional status in individuals with rotator cuff lesions. Rotator cuff pathology is a common cause of shoulder pain and functional limitation, and impairments in proprioception may further compromise shoulder motor control and recovery.
Eligible participants with rotator cuff lesions will be randomly allocated into three groups: (1) Mobilization with Movement (MWM), (2) conventional physiotherapy, and (3) control group. All participants will be evaluated before and after the intervention period. Outcome measures will include shoulder-related functional disability assessed by the QuickDASH questionnaire, pain intensity, and shoulder joint position sense evaluated using an active repositioning test with a laser pointer during shoulder flexion.
The study is designed to determine whether MWM provides additional benefits over conventional treatment or task oriented training intervention in improving pain, function, and proprioceptive accuracy. The findings are expected to contribute to evidence-based conservative rehabilitation strategies for patients with rotator cuff lesions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rotator cuff lesions are among the most common causes of shoulder pain and functional limitation, particularly in middle-aged and older adults. Due to the wide range of motion and complex biomechanics of the glenohumeral joint, integrity of the rotator cuff muscles is essential for dynamic stability, coordinated movement, and precise joint positioning. Pathological changes in the rotator cuff may lead not only to pain and reduced functional capacity but also to impairments in proprioception, which can negatively affect motor control and increase the risk of recurrent injury.
Conservative management is widely recommended as the first-line treatment for rotator cuff lesions and typically includes therapeutic exercises, physical agents, and manual therapy techniques. Mobilization with Movement (MWM), developed within the Mulligan concept, is a manual therapy approach that combines sustained accessory joint mobilization with active, pain-free physiological movement. MWM is proposed to improve joint mechanics, reduce pain, and enhance neuromuscular and proprioceptive input. While previous studies have demonstrated the effectiveness of MWM in reducing pain and improving function in various musculoskeletal conditions, evidence regarding its effects on shoulder proprioception, particularly joint position sense, in individuals with rotator cuff lesions remains limited.
This randomized controlled trial is designed to evaluate the effects of MWM on pain, functional outcomes, and joint position sense in patients with rotator cuff lesions. Eligible participants diagnosed with rotator cuff pathology will be randomly assigned to one of three groups: (1) Mobilization with Movement (MWM) group, (2) conventional physiotherapy group, or (3) task oriented training group. Randomization will be performed after baseline assessment to ensure allocation concealment.
All participants will undergo standardized assessments at baseline (pre-intervention) and after completion of the intervention period (post-intervention). Functional status of the upper extremity will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Pain intensity will be assessed using validated self-report measures. Shoulder proprioception will be assessed through a joint position sense test using an active repositioning method during shoulder flexion with a laser pointer system, recording the deviation from a predefined target point in centimeters.
The MWM group will receive manual therapy interventions based on Mulligan principles, applied by a trained physiotherapist, in addition to standard care. The conventional physiotherapy group will receive commonly used rehabilitation interventions excluding MWM techniques. The control group will not receive therapeutic intervention during the study period. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all participants prior to enrollment.
The primary objective of this study is to determine whether MWM leads to superior improvements in pain, functional ability, and joint position sense compared with conventional physiotherapy and no intervention. Secondary objectives include evaluating the magnitude of treatment effects and exploring the relationship between changes in proprioception and functional outcomes. The results of this trial are expected to provide clinically relevant evidence regarding the role of Mobilization with Movement in conservative rehabilitation protocols for individuals with rotator cuff lesions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ömer Faruk Özçelep, PhD
- Phone Number: +90 531 946 3777
- Email: omer.ozcelep@ahievran.edu.tr
Study Locations
-
-
-
Kırşehir, Turkey (Türkiye)
- Recruiting
- Ahi Evran University
-
Contact:
- Ömer Faruk ÖZÇELEP, MsC
- Email: omer.ozcelep@ahievran.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Clinical and/or imaging-confirmed diagnosis of rotator cuff lesion (e.g., tendinopathy or partial tear)
- Presence of shoulder pain for at least 3 months
- Pain and functional limitation during shoulder movements
- Ability to actively perform shoulder movements required for assessment and intervention
- No physiotherapy or manual therapy treatment for the affected shoulder within the last 3 months
Exclusion Criteria:
- History of shoulder surgery on the affected side
- Full-thickness rotator cuff tear or shoulder instability
- Shoulder fracture, dislocation, or acute trauma within the past 6 months
- Neurological disorders affecting the upper extremity (e.g., cervical radiculopathy, peripheral neuropathy)
- Systemic inflammatory or rheumatologic diseases
- Severe shoulder osteoarthritis or adhesive capsulitis
- Current participation in another clinical trial
- Use of corticosteroid injection in the affected shoulder within the last 3 months
- Pregnancy
- Inability to comply with the study protocol or assessment procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Physiotherapy Group
Participants in this arm will receive a conventional physiotherapy program commonly used in the conservative management of rotator cuff lesions.
The program will include therapeutic exercises, stretching, and physical therapy modalities aimed at reducing pain and improving shoulder function.
Mobilization with Movement or other Mulligan-based manual therapy techniques will not be applied in this group.
|
Participants allocated to the conventional physiotherapy group will receive a standard rehabilitation program commonly used for rotator cuff lesions. The intervention will include therapeutic exercises targeting shoulder range of motion, strengthening of the rotator cuff and scapular stabilizing muscles, and stretching exercises for periarticular soft tissues. Physical therapy modalities such as heat or ultrasound may be applied as needed for pain management. This intervention will be delivered by a physiotherapist according to established clinical guidelines. Mobilization with Movement or other Mulligan-based manual therapy techniques will not be included in this group. |
|
Experimental: Mobilization with Movement (MWM) Group
Participants allocated to this arm will receive Mobilization with Movement interventions based on the Mulligan concept.
The technique will involve the application of sustained accessory glenohumeral joint mobilization combined with active, pain-free shoulder movements.
Interventions will be administered by a trained physiotherapist according to a standardized protocol.
This group may also receive basic conventional physiotherapy components excluding other manual mobilization techniques.
|
Participants assigned to the Mobilization with Movement (MWM) group will receive manual therapy based on the Mulligan concept. The intervention will consist of the application of sustained, pain-free accessory mobilization to the glenohumeral joint combined with active physiological shoulder movements, primarily in shoulder flexion and abduction. The direction and grade of mobilization will be individually determined according to the patient's symptoms and movement restrictions, ensuring that all movements are performed within a pain-free range. MWM interventions will be administered by a trained physiotherapist following a standardized treatment protocol. Each treatment session will last approximately 20-30 minutes and will be applied multiple times per week throughout the intervention period. The primary goal of the intervention is to improve joint mechanics, reduce pain, and enhance proprioceptive input by facilitating normal, pain-free movement patterns. |
|
No Intervention: Task-Oriented Training (Virtual Reality) Group
Participants allocated to this arm will receive a task-oriented training program delivered through virtual reality (VR)-based rehabilitation applications.
The intervention will consist of goal-directed and functional upper extremity activities designed to simulate daily living tasks and promote active shoulder use.
Training tasks will target reaching, grasping, object manipulation, and multidirectional arm movements requiring coordination, accuracy, and motor control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Disabilities of the Arm, Shoulder and Hand questionnaire.
Time Frame: Baseline (pre-intervention) and at the end of the 8-week intervention period.
|
Upper Extremity Functional Disability, Higher scores better outcomes
|
Baseline (pre-intervention) and at the end of the 8-week intervention period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Baseline (pre-intervention) and at the end of the 8-week intervention period.
|
Pain Intensity-Lower score better outcomes
|
Baseline (pre-intervention) and at the end of the 8-week intervention period.
|
|
Joint Position Sense Error (cm)
Time Frame: Baseline (pre-intervention) and at the end of the 8-week intervention period.
|
Shoulder Joint Position Sense-Proprioception was assessed by measuring joint position sense (JPS) using a laser.Lower score better outcomes
|
Baseline (pre-intervention) and at the end of the 8-week intervention period.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEU-FTR3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Tears
-
Xiros LtdRecruitingRotator Cuff Tear | Rotator Cuff Injuries | Rotator Cuff Tears | Rotator Cuff Tears of the ShoulderUnited Kingdom
-
ZuriMED Technologies Inc.RecruitingRotator Cuff Tear | Rotator Cuff Tears | Rotator Cuff Tears of the ShoulderUnited States
-
Gazi UniversityActive, not recruitingMassive Irreparable Rotator Cuff TearsTurkey (Türkiye)
-
BAAT Medical Products B.V.Active, not recruiting
-
Parc de Salut MarHospital Clinic of Barcelona; Hospital Universitario Fundación Jiménez Díaz; Hospital... and other collaboratorsActive, not recruitingShoulder Disease | Massive Rotator Cuff TearsSpain
-
Atreon OrthopedicsCompletedRotator Cuff Tears | Full-thickness Rotator Cuff TearsUnited States
-
Anika Therapeutics, Inc.RecruitingRotator Cuff Tears of the ShoulderUnited States
-
Sohag UniversityActive, not recruitingRotator Cuff Tears of the ShoulderEgypt
-
BAAT Medical Products B.V.Recruiting
-
University of UtahEnrolling by invitationStudying the Genetic Relationship of Rotator Cuff TearsUnited States
Clinical Trials on Conventional Physiotherapy
-
Istanbul Demiroglu Bilim UniversityCompletedMuscle Weakness | Rehabilitation | Intensive Care Unit SyndromeTurkey
-
University of SalamancaCompleted
-
Pamukkale UniversityCompletedChronic Low-back PainTurkey
-
Kirsehir Ahi Evran UniversitesiEnrolling by invitation
-
International Hellenic UniversityRecruiting
-
Kutahya Health Sciences UniversityRecruitingAnterior Cruciate Ligament InjuriesTurkey
-
Bezmialem Vakif UniversityCompleted
-
Riphah International UniversityRecruitingLateral EpicondylitisPakistan
-
University of LahoreRecruitingHypotonic Cerebral PalsyPakistan
-
Eastern Mediterranean UniversityCompletedCervical SpondylosisCyprus