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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06157554
• Other study ID #: Frozen shoulder
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: December 2023
• Source: Bandirma Onyedi Eylül University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 10, 2024
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder
• Pain
• Quality of Life

Intervention

Other:
• Breathing Exercises
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.
• Conventional treatment
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.

Locations

Country	Name	City	State
Turkey	Bandirma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	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
Primary	The Short Form-36 Quality of Life Questionnaire	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
Primary	Range of motion	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