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Clinical Trials/NCT06157554
NCT06157554
Active, not recruiting
Not Applicable

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

Bandırma Onyedi Eylül University1 site in 1 country40 target enrollmentJanuary 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frozen Shoulder
Sponsor
Bandırma Onyedi Eylül University
Enrollment
40
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2023
End Date
January 10, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bandırma Onyedi Eylül University
Responsible Party
Principal Investigator
Principal Investigator

Burçin Akçay

Assistant professor

Bandırma Onyedi Eylül University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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.

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.

Study Sites (1)

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