NCT07525297

Brief Summary

Rotator cuff pathology is defined as the degeneration or tear of one or more of the muscles or tendons of the rotator cuff, namely the supraspinatus, infraspinatus, teres minor, and subscapularis. Shoulder girdle biomechanics are not solely comprised of the glenohumeral joint but are built upon a kinetic chain involving the synchronized movement of the scapula, clavicle, and thoracic spine. In this context, the concept described in the literature as the "Regional Dependence" model argues that functional impairment in a distal segment like the shoulder may stem from or exacerbate limitations in a more proximal region like the thoracic spine. Conventional treatment approaches that focus solely on the shoulder joint may have limited clinical outcomes due to neglecting the fundamental link in the kinetic chain. Maintained natural apophyseal glides (SNAGs), a cornerstone of Mulligan's Concept in spinal rehabilitation, are a dynamic manual therapy technique aimed at correcting microscopic misalignments in facet joints during active movement. The aim of this randomized controlled trial is to investigate the effects of thoracic mobilization added to the Mulligan movement shoulder mobilization technique on pain intensity, range of motion, proprioception, and upper extremity functionality in individuals with rotator cuff pathology, and to evaluate the superiority of this combined approach over shoulder mobilization alone. Assessments will be performed before treatment and at the end of the 3-week intervention. Rest and activity pain intensity will be assessed using the Pain Numerical Rating Scale (PMR), shoulder range of motion using a digital goniometer, thoracic kyphosis degrees using a smartphone with the 'Angle Meter' software installed and calibrated gyroscope and accelerometer sensors, functionality using the Shoulder Pain and Disability Index (SPAI), and proprioception using a laser pointer and target device. The obtained data will be compared using appropriate statistical analysis methods. This study is expected to provide scientific evidence regarding the clinical effectiveness of thoracic mobilization technique added to shoulder mobilization technique applied in conjunction with conventional treatment in individuals with rotator cuff pathology, and to contribute to filling the methodological gap mentioned in the literature.

Trial Health

63
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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 Progress31%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

Rotator cuff injuriesManual therapyExerciseShoulder jointThoracic Vertebrae

Outcome Measures

Primary Outcomes (3)

  • Thoracic kyphosis angle

    Participants' thoracic kyphosis degrees will be measured via a smartphone equipped with 'Angle Meter' software, a digital inclinometer.

    From enrollment to the end of treatment at 3 weeks

  • Proprioception

    Proprioception will be assessed using a laser pointer and millimeter graph paper. The laser pointer will be secured to the participant's arm just above the lateral epicondyle, parallel to the arm, using an elastic bandage. The participant will be positioned in a seated position 1 meter away from the millimeter graph paper. The amount of linear deviation on the millimeter graph paper will be converted into angular error using a trigonometric formula based on the distance between the center of the shoulder joint and the paper.

    "From enrollment to the end of treatment at 3 weeks

  • Range of motion

    Range of motion will be assessed using a universal goniometer.

    "From enrollment to the end of treatment at 3 weeks

Secondary Outcomes (2)

  • Shoulder pain

    From enrollment to the end of treatment at 3 weeks

  • Shoulder Functionality

    From enrollment to the end of treatment at 3 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Conventional Physiotherapy Program, Mulligan Mobilization with Movement

Procedure: Mulligan Mobilization with MovementOther: Conventional Physiotherapy Program

Intervention Group

EXPERIMENTAL

Conventional Physiotherapy Program, Mulligan Mobilization with Movement and Thoracic Spine Mobilization

Procedure: Mulligan Mobilization with MovementProcedure: Thoracic Spine MobilizationOther: Conventional Physiotherapy Program

Interventions

Conventional physiotherapy program including hot pack application (20 minutes), TENS (80-100 Hz frequency, 50-100 µs impulse duration, 20 minutes), therapeutic ultrasound (1-3 MHz frequency, 1.0-1.5 W/cm² intensity, continuous mode, 7 minutes), and supervised exercise program consisting of pendulum exercises, stick exercises for range of motion, scapular stabilization exercises (retraction, Y-W-T), and progressive strengthening exercises (isometric and dynamic) for rotator cuff muscles.

Control GroupIntervention Group

Mobilization with Movement technique applied to the shoulder joint according to Mulligan concept to improve pain and range of motion.

Control GroupIntervention Group

Manual mobilization techniques applied to thoracic spine segments to improve thoracic mobility and contribute to shoulder function.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Having been diagnosed with unilateral rotator cuff pathology (impingement syndrome, tendinopathy, or partial tear) by a specialist physician through clinical examination and/or radiological imaging (USG/MR);
  • Being between 18 and 65 years of age;
  • Having shoulder pain that has persisted for at least 3 months;
  • Having a positive result on at least two of the Neer, Hawkins-Kennedy, and Empty Can tests;
  • Having a pain intensity of at least 3/10 on the Pain Numerical Rating Scale (NPRS) during rest or activity;
  • Having sufficient cognitive ability to follow simple instructions and administer the tests;
  • Having a Mini Mental State Test score ≥24;
  • Having the ability to provide signed informed consent and agreeing to participate in the study voluntarily.

You may not qualify if:

  • Having undergone previous surgery on the shoulder or thoracic region;
  • Having full-thickness rotator cuff tears requiring surgical indication;
  • Having adhesive capsulitis, shoulder instability, labrum tears, or calcific tendinitis;
  • Having cervical radiculopathy or neurological diseases affecting the upper extremity;
  • Having uncontrolled diabetes, inflammatory rheumatic diseases (rheumatoid arthritis, etc.), or malignancy;
  • Having severe osteoporosis, unstable vertebral fractures, or active infection in the thoracic region;
  • having received steroid (cortisone) or PRP injections to the shoulder region within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesMotor Activity

Interventions

Movement

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesBehavior

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ayşe Merve Tat, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations