- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06157554
The Effect of Breathing Exercises in Addition to Conventional Treatment in Frozen Shoulder Patients
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Balıkesir, Turkey
- Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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.
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Other: Control Group
For frozen shoulder patients, 15 conventional treatment programs will be applied.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale
Time Frame: 3 weeks
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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).
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3 weeks
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The Short Form-36 Quality of Life Questionnaire
Time Frame: 3 weeks
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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.
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3 weeks
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Range of motion
Time Frame: 3 weeks
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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.
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3 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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