The Effect of Breathing Exercises in Addition to Conventional Treatment in Frozen Shoulder Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
1 active site
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
Study Start
First participant enrolled
January 10, 2023
CompletedFirst Submitted
Initial submission to the registry
November 21, 2023
CompletedFirst Posted
Study publicly available on registry
December 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2024
CompletedDecember 6, 2023
December 1, 2023
11 months
November 21, 2023
December 4, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
Intervention group
EXPERIMENTALRespiratory exercises will be applied in addition to conventional treatment for frozen shoulder patients.
Control Group
OTHERFor frozen shoulder patients, 15 conventional treatment programs will be applied.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Balıkesir, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
November 21, 2023
First Posted
December 6, 2023
Study Start
January 10, 2023
Primary Completion
December 10, 2023
Study Completion
January 10, 2024
Last Updated
December 6, 2023
Record last verified: 2023-12