NCT05584345

Brief Summary

As it causes pain and disability in individuals with rotator cuff lesions, which is one of the most common causes of shoulder pain, it affects performance in activities of daily living. Shoulder pain significantly affects the quality of life of individuals. The aim of conventional treatment in Rotator Cuff injuries is to reduce the inflammation in the area and to enable the shoulder to perform its normal functions. Conventional treatment is to restore muscle balance in the shoulder area. Muscle balance is achieved by strengthening the teres minor, infraspinatus, and subscapularis, which are also the humeral head depressors, and by strengthening the serratus anterior, levator scapula. For strengthening, the shoulder must have a full range of motion. In our study, stretching exercises, cold pack, Ultrasound, TENS, wand, and Codman exercises, which are classical physiotherapy methods, will be applied to all three groups. There are also studies in the literature investigating the effects of traditional physiotherapy methods on individuals with shoulder Rotator Cuff syndrome. The benefits of breathing exercises on pain, shoulder joint range of motion, and balance have all been researched in the literature. Increased diaphragm activity also guarantees that posture and body positions are maintained healthily. Diaphragm activity generally alters how an individual perceives pain. Diaphragmatic breathing is a therapeutic approach for musculoskeletal disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 20, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

October 30, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

September 20, 2022

Last Update Submit

December 1, 2025

Conditions

Keywords

respiratory exercisesrotator cuff syndromepain

Outcome Measures

Primary Outcomes (1)

  • Visual Analog scale (VAS)

    Pain intensity will be with VAS that is a tool commonly used to assess the intensity of musculoskeletal pain (18). The VAS will be used to evaluate the level of shoulder pain experienced by participants at rest, and during activity. Participants were asked to rate their pain intensity on a scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." The participants' responses will be recorded in the case report forms.

    From enrollment to the end of treatment at six weeks

Secondary Outcomes (2)

  • Goniometric Measurement

    From enrollment to the end of treatment at six weeks

  • DASH

    From enrollment to the end of treatment at six weeks

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

Traditional physiotherapy applications will be applied.

Other: Conventional Treatment and manual therapy

breathing exercises and conventional therapy program

EXPERIMENTAL

In addition to traditional physiotherapy, respiratory exercises will be applied.

Other: Manual therapy and Respiratory Exercises

Interventions

Cold pack, ultrasound, TENS, finger ladder, Codman, shoulder wheel, and Wand exercises, as well as stretching and capsule exercises, will be used in addition to conventional physiotherapy. There will be 30 repetitions in each direction of the Codman exercises. 5 days a week, for a total of 30 sessions, the afflicted shoulder will get 6 minutes of daily US treatment, with complete contact to the shoulder area and at a right angle. All patients will receive manual stretching in the shoulder flexion, abduction, extension, external rotation, and internal rotation directions. In addition, participants will receive manual therapy techniques, including Glenohumeral joint (GH) distraction, glenohumeral joint inferior gliding, anterior gliding, and posterior gliding, scapulothoracic joint distraction, scapulothoracic joint superior, inferior, medial, and lateral gliding. Each manual therapy technique was performed with 10 repetitions per participant

Conventional therapy

In addition to the treatment program applied in conventional therapy and manual therapy,, participants in this group also will perform diaphragmatic breathing exercises, pursed-lip breathing exercises, and relaxation breathing exercises. Each breathing exercise will be performed with 10 repetitions under physiotherapist supervision. Participants were also asked to continue the breathing exercises at home, performing them three times a day with 10 repetitions per session for a duration of six weeks.

breathing exercises and conventional therapy program

Eligibility Criteria

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

You may qualify if:

  • The participants were between the ages of 30 and 55
  • No history of shoulder surgery
  • Exhibited restricted shoulder joint range of motion,
  • A diagnosed rotator cuff tear

You may not qualify if:

  • individuals with a history of significant shoulder trauma
  • anatomical deformities, skeletal fractures, diagnosed orthopedic or rheumatologic disorders, participation in a physiotherapy program within the last six months
  • Presence of a cardiac pacemaker, current infections, recent myocardial infarction (within the last six months), or any other condition that could interfere with their ability to perform the prescribed exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • BURAK MENEK, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR
  • UMUT İSLAM TAYBOĞA, RA

    Medipol University

    PRINCIPAL INVESTIGATOR
  • Sule Ayan, Msc

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2022

First Posted

October 18, 2022

Study Start

October 30, 2022

Primary Completion

July 3, 2023

Study Completion

July 3, 2023

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations