NCT07377292

Brief Summary

The aim of this study is to investigate the effectiveness of core stabilization exercises added to conventional physical therapy in patients aged 40-60 with rotator cuff tears, compared to classic trunk and abdominal muscle strengthening exercises.

Trial Health

63
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Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 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 Progress24%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

February 25, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 22, 2026

Last Update Submit

January 22, 2026

Conditions

Keywords

Core exercise trainingRotator Cuff İnjuryExercise

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Pain intensity on the VAS (visual analog scale) is generally rated as "no pain" 0 points and "the most severe pain imaginable" 10 points (10 cm scale). Pain intensity scoring ranges are specified as \<3 mild pain, 3-6 moderate pain, \>6 severe pain.

    Before Treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)

Secondary Outcomes (4)

  • Tendon Thickness

    Before Treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)

  • Shoulder Pain and Disability Index (SPADI)

    Before Treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)

  • Range Of Motion (ROM)

    Before Treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)

  • Core Muscle Strength

    Before Treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)

Study Arms (3)

Core Stabilization Group

ACTIVE COMPARATOR

Patients received conventional rehabilitation for the affected shoulder 5 days a week for 4 weeks and core stabilization exercises 3 days a week for 4 weeks.

Other: Core Stabilization ExercisesOther: Conventional Rehabilitation

Classic Body Exercise Group

ACTIVE COMPARATOR

Patients will receive conventional rehabilitation for the affected shoulder 5 days a week for 4 weeks, along with a classic trunk and abdominal strengthening program 3 days a week for 4 weeks.

Other: Classic Trunk and Abdominal Strengthening ProgramOther: Conventional Rehabilitation

Control Group

PLACEBO COMPARATOR

Patients will receive conventional rehabilitation for the affected shoulder five days a week for four weeks.

Other: Conventional Rehabilitation

Interventions

The program will be set up for 3 days a week over 4 weeks, consisting of a 35-minute session including a 5-minute warm-up, supervised by a physical therapist. Classic Williams 1-2-3 and McKenzie exercises will be provided.

Classic Body Exercise Group

1. Passive, assisted active, and active shoulder flexion, abduction, external rotation, and internal rotation exercises in the supine position 2. Active shoulder range of motion (ROM) exercises in a sitting or standing position 3. Shoulder flexion strengthening exercises 4. Shoulder external rotator and internal rotator strengthening exercises 5. Exercises to strengthen the lower, middle trapezius, and serratus anterior muscles 6. Posterior capsule stretching exercises 7. TENS (20 minutes) 8. Cold pack (10 minutes)

Classic Body Exercise GroupControl GroupCore Stabilization Group

The program will be set up as a 35-minute session, including a 5-minute warm-up, three days a week for four weeks, under the supervision of a physical therapist. Before starting the exercise, the pelvis will be moved forward and backward to teach the lumbar and pelvic neutral positions by contracting and pulling the abdominal muscles to reduce lumbar lordosis. A neutral position will be established before each session, and care will be taken to maintain the neutral position throughout the exercise. The exercises consist of three levels and will be applied gradually. The exercises given at the beginning will be made more difficult individually according to the patients' progress. When the patient can maintain the exercise position for more than 5 seconds, they will move on to the next level. A deep breath will be taken before starting the exercise, and the breath will be exhaled during the movement. The contraction of the transversus abdominis muscle should continue while exhaling.

Core Stabilization Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 40 to 60 years with a partial supraspinatus tear detected by MRI, reported by a radiologist, and confirmed by a physiatrist.
  • Patients who test positive for at least two of the Jobe, Hawkins and Neer tests during the physical examination
  • Patients with a visual analog scale (VAS) score between 3.5 and 7.4 millimeters (mm)

You may not qualify if:

  • Participants do not wish to continue treatment for any reason
  • Complete or massive rotator cuff tear
  • Use of non-steroidal or steroidal anti-inflammatory drugs
  • If they have received shoulder injections or physical therapy within the three months prior to the study
  • History of acute trauma
  • Presence of neurological disease
  • History of surgery on the treated shoulder
  • Symptomatic acromioclavicular joint arthritis
  • Frozen shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesMotor Activity

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesBehavior

Central Study Contacts

Başak ÇİĞDEM KARAÇAY

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups along with the exercise control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations