NCT07053566

Brief Summary

The aim of this study is to investigate the effects of strengthening exercises targeting the latissimus dorsi muscle on acromiohumeral distance, shoulder function, and pain levels in individuals with rotator cuff tendinopathy. By increasing the activation of the latissimus dorsi, one of the shoulder adductor muscles, the exercises are expected to facilitate inferior gliding of the humeral head and improve subacromial distance. Individuals aged between 18 and 50 years with a diagnosis of rotator cuff tendinopathy will be included in the study. A total of 47 participants will be enrolled and randomly assigned to one of three groups: A group performing exercises targeting only the rotator cuff muscles, A group performing exercises targeting the latissimus dorsi muscle, A group performing a combination of both rotator cuff and latissimus dorsi exercises. The exercise interventions will be applied over a 12-week period. Before and after the intervention, the following outcomes will be assessed: Acromiohumeral distance (via ultrasound), Range of motion, Shoulder function and pain using the SPADI and WORC questionnaires, and Avoidance behavior using the Adap-Tr questionnaire.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress41%
May 2025Sep 2027

Study Start

First participant enrolled

May 23, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2027

Last Updated

September 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

June 18, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Exercise TheraphyShoulder RehabilitationRotator CuffLatissimus Dorsi

Outcome Measures

Primary Outcomes (3)

  • Acromio-humeral distance

    The acromiohumeral distance will be assessed using ultrasonography. Measurements will be performed by a physician blinded to the participants' group assignments, ensuring assessor blinding. Ultrasonographic measurement of the acromiohumeral distance has been shown to be reliable (intraclass correlation coefficient \> 0.90), and the minimal detectable change has been reported as 1.2 mm

    Measurements will be performed at baseline and at the end of the 12th week

  • Pain İntensity

    Pain intensity will be assessed using the Visual Analog Scale (VAS) at rest, during activity, and at night. On the VAS, a score of 0 indicates no pain, while a score of 10 represents unbearable pain. Higher scores reflect greater pain intensity.he scale will be explained to the patient in a face-to-face setting, and they will be asked to mark their pain levels at rest, during activity, and at night on a 100-millimeter horizontal line.

    Baseline and weekly up to 12 weeks

  • Shoulder Range of Motion

    ll measurements will be performed with the patient in the supine position. For shoulder flexion ROM, the patient will be asked to raise their arm upward in the sagittal plane. For shoulder abduction ROM, the patient will be instructed to move their arm laterally in the scapular plane.For external and internal rotation ROM measurements, the shoulder will be positioned at 90° of abduction and the elbow at 90° of flexion.For external rotation, the patient will be asked to move the forearm upward in the sagittal plane, with the palm facing toward themselves and in the direction of the thumb. For internal rotation, the patient will be asked to move the forearm downward in the sagittal plane, in the direction of the index finger.

    Baseline and weekly up to 12 weeks

Secondary Outcomes (3)

  • ADAP-Shoulder Scale (Avoidance Behavior)

    Measurements will be performed at baseline and at the end of the 12th week.

  • Shoulder Pain and Disability Index (SPADI)

    At baseline and at the end of Week 12

  • Western Ontario Rotator Cuff Index (WORC)

    Measurements will be performed at baseline and at the end of the 12th week.

Study Arms (3)

Rotator Cuff Exercise Group (RCEG)

EXPERIMENTAL

Progressive strengthening program for rotator cuff muscles.

Behavioral: Rotator Cuff Strengthening Exercises

Latissimus Dorsi Exercise Group (LDEG)

EXPERIMENTAL

Progressive strengthening program for latissimus dorsi muscle.

Behavioral: Latissimus Dorsi Strengthening Exercises

Combined Exercise Group (CEG)

EXPERIMENTAL

Combined strengthening program for rotator cuff and latissimus dorsi muscles

Behavioral: Rotator Cuff Strengthening ExercisesBehavioral: Latissimus Dorsi Strengthening Exercises

Interventions

Progressive exercise program focused on rotator cuff muscles

Combined Exercise Group (CEG)Rotator Cuff Exercise Group (RCEG)

Progressive exercise program targeting the latissimus dorsi muscle

Combined Exercise Group (CEG)Latissimus Dorsi Exercise Group (LDEG)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 50 years
  • At least 3 months of ongoing shoulder pain
  • At least 3 positive tests out of 5 (Neer, Hawkins-Kennedy, Jobe, Painful Arc Sign, Pain on Resisted External Rotation)
  • Ultrasound diagnosis of rotator cuff tendinopathy
  • Shoulder pain during activity rated greater than 3 out of 10 on the Numeric Pain Scale
  • Central Sensitization Inventory score below 40

You may not qualify if:

  • Bilateral shoulder pain
  • History of surgery or dislocation in the symptomatic shoulder
  • Acromioclavicular degeneration
  • Presence of shoulder capsulitis (restriction in passive glenohumeral range of motion in 2 or more directions)
  • Full-thickness rotator cuff tear
  • Shoulder osteoarthritis, rheumatoid arthritis, systemic inflammatory or neurological disease
  • Any injection to the symptomatic shoulder within the past 6 weeks
  • BMI greater than 30 kg/m2
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
In this study, both the participants and the investigator (physician) are blinded to the group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Principal Investigator

Study Record Dates

First Submitted

June 18, 2025

First Posted

July 8, 2025

Study Start

May 23, 2025

Primary Completion (Estimated)

May 22, 2027

Study Completion (Estimated)

September 22, 2027

Last Updated

September 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to privacy and ethical considerations.

Locations