The Effect of Breathing Exercises in Addition to Conventional Treatment in Frozen Shoulder Patients

December 4, 2023 updated by: Burçin Akçay, Bandırma Onyedi Eylül University

The Effect of Breathing Exercises in Addition to Conventional Treatment on Pain, Normal Joint Movement and Quality of Life in Frozen Shoulder Patients: a Randomized Controlled Trial

The study aimed to investigate the effect of breathing exercises in addition to conventional treatment on pain, normal joint movement and quality of life in patients with frozen shoulder.

A simple random number table will randomly divide participants into two groups. The study group (20 participants) will be given 15 sessions of respiratory exercises in addition to the 15 sessions of physiotherapy provided routinely for treatment. The control group (20 participants) will receive 15 sessions of physiotherapy services in addition to the routine 15 sessions of the physiotherapy department.

Study Overview

Status

Active, not recruiting

Detailed Description

After completing the demographic information form, a visual analog scale will be used for pain intensity, a Baseline digital goniometer will be used to measure the normal joint range of the shoulder girdle, and a Short form SF-36 will be used for quality of life. All participants will be evaluated before and after 15 sessions. The same assessments will be performed in both groups. The evaluations are expected to last 40 minutes in total.

The study group (20 participants) will be given 15 sessions of respiratory exercises in addition to the 15 sessions of physiotherapy provided routinely for treatment. The control group (20 participants) will receive 15 sessions of physiotherapy services in addition to the routine 15 sessions of the physiotherapy department.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Balıkesir, Turkey
        • Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 18-65
  • Having a diagnosis of a frozen shoulder,
  • Volunteering to participate in the study
  • Not having any problem that may prevent respiratory exercise.

Exclusion Criteria:

  • Not volunteering to participate in the study,
  • Having undergone upper extremity surgery,
  • History of previous shoulder surgery, shoulder subluxation or dislocation,
  • Any mental or sensory problems,
  • Acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin,
  • Having any respiratory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Respiratory exercises will be applied in addition to conventional treatment for frozen shoulder patients.
During the exercise sessions, participants will be seated in a chair. In the first five and last five minutes of the session, they will be instructed to focus on their breathing and the sensations produced in the body while sitting comfortably in a relaxed position with all joints in the chairs with their eyes closed. After the initial 5 minutes of relaxed breathing, participants will be instructed to perform diaphragmatic and costal breathing for 10 minutes. After 5 minutes of diaphragmatic breathing, the patient will be rested for 1 minute and then 5 minutes of costal breathing will be performed. While doing coastal breathing, patients will be asked to place their hands on their costas, take a deep breath and inflate the bottom of their hands; then they will be asked to exhale the breath they take in a longer (1:2) time.
Ultrasound, hotpack and TENS will be applied to both control and study groups as physical therapy modality. Then 15 sessions of Codman exercises, normal range of motion exercises and stretching exercises will be applied to both groups.
Other: Control Group
For frozen shoulder patients, 15 conventional treatment programs will be applied.
Ultrasound, hotpack and TENS will be applied to both control and study groups as physical therapy modality. Then 15 sessions of Codman exercises, normal range of motion exercises and stretching exercises will be applied to both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 3 weeks
In this study, the severity of shoulder pain will be evaluated with the Visual Analogue Scale. According to the VAS, pain intensity is graded as "no pain" 0 points and "worst unbearable pain" 10 points (10 cm scale).
3 weeks
The Short Form-36 Quality of Life Questionnaire
Time Frame: 3 weeks
The Short Form-36, frequently used to assess quality of life, will be used. SF-36 consists of eight subscales including physical function, physical role, emotional function, social function, general health, mental health, pain and wellness. Each subscale scores between 0-100, and the scale is directly proportional to quality of life. A score of 100 indicates the best health status and a score of 0 indicates the worst health status.
3 weeks
Range of motion
Time Frame: 3 weeks
In the study, a digital goniometer, which has been validated and reliable, was used to objectively evaluate the normal range of motion of the shoulder. Normal range of motion of the shoulder will be evaluated by measuring the range of motion of shoulder flexion, extension, abduction, internal rotation and external rotation movements.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Estimated)

December 10, 2023

Study Completion (Estimated)

January 10, 2024

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Frozen shoulder

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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