NCT07383038

Brief Summary

This randomized controlled trial aims to investigate the effects of Mobilization with Movement (MWM) on pain, functional status, and joint position sense 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 no 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 20, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

rotator cuff lesionsMulligan mobilizationjoint position sense

Outcome Measures

Primary Outcomes (1)

  • Quick Disabilities of the Arm, Shoulder and Hand questionnaire.

    Upper Extremity Functional Disability, Higher scores better outcomes

    Baseline (pre-intervention) and at the end of the 8-week intervention period.

Secondary Outcomes (2)

  • Visual Analog Scale

    Baseline (pre-intervention) and at the end of the 8-week intervention period.

  • Joint Position Sense Error (cm)

    Baseline (pre-intervention) and at the end of the 8-week intervention period.

Study Arms (3)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

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.

Other: Conventional Physiotherapy

Mobilization with Movement (MWM) Group

EXPERIMENTAL

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.

Other: Mulligan mobilization

Control Group

NO INTERVENTION

Participants assigned to the control arm will not receive any physiotherapy or manual therapy intervention during the study period. They will undergo the same assessment procedures as the other groups at baseline and post-intervention. After completion of the study, participants in the control group will be offered appropriate rehabilitation if required.

Interventions

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.

Mobilization with Movement (MWM) 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.

Conventional Physiotherapy 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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University

Kırşehir, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Ozlu O, Sahin M. The effect of mulligan mobilization technique application in addition to conventional physiotherapy on pain and joint range of motion in people with neck pain. J Bodyw Mov Ther. 2024 Jul;39:225-230. doi: 10.1016/j.jbmt.2024.02.009. Epub 2024 Mar 5.

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Central Study Contacts

Ömer Faruk Özçelep, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
This study will be conducted using a single-blind design. Due to the nature of the manual therapy interventions, it is not feasible to blind participants or treating physiotherapists to group allocation. However, the outcome assessor will be blinded to the participants' group assignments in order to minimize measurement and assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is designed as a randomized, parallel-group interventional clinical trial. Eligible participants diagnosed with rotator cuff lesions will be prospectively assigned to one of three intervention arms: Mobilization with Movement (MWM), conventional physiotherapy, or a control group. Allocation to study arms will be performed using a randomization procedure to minimize selection bias and to ensure comparability between groups at baseline. Each study group will follow its assigned intervention protocol throughout the intervention period, and participants will remain in the same group for the duration of the study (parallel assignment). Outcomes will be assessed at two time points: before the initiation of the intervention (baseline) and after completion of the intervention period (post-intervention). There will be no crossover between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 3, 2026

Study Start

August 25, 2025

Primary Completion

April 25, 2026

Study Completion

April 28, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data collected in this study will not be made publicly available. Aggregate data and study results will be reported in scientific publications and presentations without including any identifiable participant information.

Locations