The Effect of Diaphragmatic Breathing Exercises Applied in Addition to Conventional Treatment on Pain, Upper Extremity Stability, and Anxiety in Individuals With Rotator Cuff Lesion

NCT07091903 | Completed

• 1 other identifier: Breath in rotator cuff lesion
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate the effects of diaphragmatic breathing exercises in addition to conventional treatment and post isometric relaxation technique on pain, range of motion, functionality, upper extremity stability, and anxiety in individuals with rotator cuff lesions. The study included 32 participants aged between 18 and 65 years, diagnosed with rotator cuff lesions. The control group (n=16) received conventional treatment and the post-isometric relaxation technique, while the respiratory group (n=16) received diaphragmatic breathing exercises in addition to conventional treatment and the post-isometric relaxation technique. The researcher used the Visual Analog Scale (VAS) to assess pain intensity, a universal goniometer to measure range of motion, the Shoulder Pain and Disability Index (SPADI) to evaluate functional status, the Upper Extremity Y-Balance Test to assess upper extremity stability, the State-Trait Anxiety Inventory (STAI) to measure anxiety levels, and a finger-type pulse oximeter to record pulse and oxygen saturation values. The researcher used SPSS V.27 program for statistical analysis of the data.

Conditions

Rotator Cuff Lesions

Keywords

Rotator Cuff Lesions; Anxiety; Diaphragmatic Breathing Exercise; Pain; Upper Extremity Stability

Outcome Measures

Primary Outcomes (7)

• Range of Motion of the Shoulder Joint

  In our study, individuals' shoulder joint range of motion was measured with a "universal goniometer" and evaluated. Goniometric measurement is an objective method frequently used in ROM evaluation. Before and after treatment, individuals' shoulder flexion, extension, abduction, external rotation and internal rotation active range of motion was measured with a universal goniometer. Measurements were made 3 times and the average of each measurement was recorded.

  6 weeks

• Shoulder Pain

  In our study, pain was assessed using the Visual Analog Scale (VAS). The Visual Analog Scale is a scale in which pain intensity is expressed by marking on a line 0-10 cm long. Before the assessment, participants were informed that the numbers on the scale were expressed as "'0: no pain' and '10: unbearable pain'" and were asked to mark the intensity of pain they felt at rest, during activity, and at night on the line.

  6 weeks

• Shoulder Functionality

  Patients' functionality was assessed with the Shoulder Pain and Disability Index (SPADI). The index was developed to measure pain and disability. It contains 5 questions for pain and 8 questions for disability. Patients are asked to answer each question on a scale from 0 to 10 (0 = no pain/strain; 10 = maximum pain experienced/inability to do anything). The score is calculated separately for pain, disability, and total score. The score is calculated by adding the scores for each section, dividing by the maximum possible score for that section, and multiplying by 100. Higher scores indicate greater pain and disability.

  6 weeks

• Anxiety

  The State-Trait Anxiety Inventory (STAI) was used to assess patients' anxiety levels. The original version of the scale was developed by Spielberger and colleagues. This self-assessment scale consists of two subscales: State and Trait Anxiety. State anxiety assesses an individual's level of anxiety in a given situation, while trait anxiety indicates an individual's tendency to experience anxiety. The scale consists of 40 items (20 for state anxiety and 20 for trait anxiety), and each item is scored from 1 to 4. The total score ranges from 20 to 80. Higher scores indicate higher anxiety levels.

  6 weeks

• Upper Extremity Stability and Mobility

  The Y-Balance Test was used to assess patients' upper extremity stability and mobility. The upper extremity Y-Balance test is a functional test that allows simultaneous assessment of upper extremity stability, core stability, and contralateral upper extremity mobility. In the test, the subject stabilizes body weight with one upper extremity while maximally extending the other extremity in three directions. Due to the cost of the original Y-Balance Test kit, a modified Y-Balance test was used in our study. The farthest distance reached in each direction was recorded in cm. Three measurements were taken on the right and left arms. To eliminate the upper extremity length advantage, composite values were calculated for both the right and left extremities.

  6 weeks

• Pulse

  Pulse oximetry is a non-invasive, painless, and reliable method for measuring oxygen saturation in arterial blood. Patients' pulse values were assessed using a finger-type pulse oximetry device.

  6 weeks

• Oxygen Saturation

  Pulse oximetry is a non-invasive, painless, and reliable method for measuring oxygen saturation in arterial blood. Patients' oxygen saturation values were assessed using a finger-type pulse oximetry device.

  6 weeks

Study Arms (2)

The Respiratory Group

EXPERIMENTAL

Diaphragmatic breathing exercises in addition to conventional physiotherapy and post-isometric relaxation technique were applied to the respiratory group.

Other: Diaphragmatic breathing exercise; Other: Conventional physiotherapy and post-isometric relaxation technique

The Control Group

EXPERIMENTAL

Conventional treatment and post-isometric relaxation technique were applied to the control group.

Other: Conventional physiotherapy and post-isometric relaxation technique

Interventions

Diaphragmatic breathing exercise OTHER

Individuals in the respiratory group received a physiotherapy and rehabilitation program for 6 weeks, 3 days a week. Diaphragmatic breathing exercise was performed with the participants in a supine position with bent knees, 10 repetitions and 3 sets.

The Respiratory Group

Conventional physiotherapy and post-isometric relaxation technique OTHER

Individuals in the respiratory group received a physiotherapy and rehabilitation program for 6 weeks, 3 days a week. The treatment of individuals in this group included conventional physiotherapy and post-isometric relaxation technique. Conventional treatment included an exercise program consisting of Wand, Codman, and finger ladder exercise, in addition to 20 min HotPack, 20 min TENS and 5 min Ultrasound modalities. Each of the exercises was applied as 10 repetitions and 1 sets. Post-isometric relaxation technique was applied with 5 seconds of isometric contraction in the direction of flexion, abduction, internal and external rotation, 5 repetitions, 2 sets.

The Control Group; The Respiratory Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between 18 and 65 years of age,
• Having been diagnosed with a rotator cuff lesion,
• Having unilateral shoulder pain that has persisted for at least 4 weeks,
• Having no cognitive or mental problems,
• Individuals who are willing to participate in the study and are willing to cooperate.

You may not qualify if:

• Patients who have received local corticosteroid injections or corticosteroid treatment within the last three months,
• Patients who have a total rotator cuff tear (Stage 3 according to Neer),
• Patients who have shoulder instability or fractures,
• Patients who have a history of shoulder, upper extremity, or thoracic surgery,
• Patients who have neuromuscular disease, unstable angina, malignancy, pulmonary or vascular problems, inflammatory arthritis, vertigo, various vestibular system pathologies, and communication problems.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (2)

• Lee BK. Effects of the combined PNF and deep breathing exercises on the ROM and the VAS score of a frozen shoulder patient: Single case study. J Exerc Rehabil. 2015 Oct 30;11(5):276-81. doi: 10.12965/jer.150229. eCollection 2015 Oct.

  PMID: 26535219 BACKGROUND

• Fernandez-Lopez I, Pena-Otero D, Atin-Arratibel MLA, Eguillor-Mutiloa M, Bravo-Llatas C, Genoves-Crespo M, Callejas-Gonzalez FJ. Effects of diaphragm muscle treatment in shoulder pain and mobility in subjects with rotator cuff injuries: A dataset derived from a pilot clinical trial. Data Brief. 2021 Feb 12;35:106867. doi: 10.1016/j.dib.2021.106867. eCollection 2021 Apr.

  PMID: 33665260 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants does not know which type of treatment is received themselves.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Physiotherapist

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 29, 2025
• Study Start: May 2, 2024
• Primary Completion: December 6, 2024
• Study Completion: June 10, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)