- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05710939
Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients
January 26, 2023 updated by: Hakan Polat, Sanko University
Comparison of the Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients
Our study was conducted to investigate the effect of scapular stabilization exercise training on cervical posture and pain in fibromyalgia.
59 patients aged 18-60 years were included in the study.
The patients included in the study were diagnosed with fibromyalgia from the physical therapy outpatient clinic and individuals who did not have any other disease were included.
The included individuals were divided into 2 groups by randomization method.
Individuals were divided into scapula exercise therapy group (n=29) and classical exercise therapy group (n=30).
Hotpack, tens and ultrasound applications were applied to both groups as conventional treatment before exercise.
This protocol was applied to both groups for 6 weeks, 5 days a week.
Following this protocol, classical shoulder exercises were given to the classical group and stabilization exercises were given to the scapular stabilization group.
While the study designer applied the treatment, another designer applied the evaluation.
The patients were evaluated for pain, cervical posture, functional status, and quality of life.
pain was evaluated with a visual analog scale (vas), cervical posture was evaluated by tragus-wall distance, functional status was evaluated with fibromyalgia impact questionnaire and quality of life was evaluated with nottingam quality of life questionnaire.
All evaluations were performed twice before and at the end of the treatment (6 weeks).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pain is usually seen in the scapular region in patients with fibromyalgia.
We decided to do this study because we thought that there was no exercise for this area before in our study and that if it was done, improvements in pain and posture could be observed.
Our study was conducted to investigate the effect of scapular stabilization exercise training on cervical posture and pain in fibromyalgia.
59 patients aged 18-60 years were included in the study.
The patients included in the study were diagnosed with fibromyalgia from the physical therapy outpatient clinic and individuals who did not have any other disease were included.
The included individuals were divided into 2 groups by randomization method.
Individuals were divided into scapula exercise therapy group (n=29) and classical exercise therapy group (n=30).
Hotpack, tens and ultrasound applications were applied to both groups as conventional treatment before exercise.
This protocol was applied to both groups for 6 weeks, 5 days a week.
Following this protocol, classical shoulder exercises (wand exercises, codman exercises and stretching exercises) were given to the classical group, and stabilization exercises (push-up exercises on the wall, scapular adduction, scapular elevation, rowing exercises) were given to the scapular stabilization group.
While the study designer applied the treatment, another designer applied the evaluation.
The patients were evaluated for pain, cervical posture, functional status, and quality of life.
pain was evaluated with a visual analog scale (vas), cervical posture was evaluated by tragus-wall distance, functional status was evaluated with fibromyalgia impact questionnaire and quality of life was evaluated with nottingam quality of life questionnaire.
All evaluations were performed twice before and at the end of the treatment (6 weeks).
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- between the ages of 18-60,
- Have not received any physical therapy and exercise therapy in the last 6 months,
- No musculoskeletal problems,
- Having no barriers to exercise therapy
- individuals were included in the study.
Exclusion Criteria:
- Individuals with psychological, cardiovascular and neurological problems,
- Female individuals with pregnancy status,
- Individuals who do not want to participate in physical therapy and exercise practices excluded from the study.
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 |
---|---|
Active Comparator: scapular stabilization exercises
scapular stabilization exercises applied to 1st group for 5 days/week for 6 weeks
|
|
Active Comparator: classic shoulder exercises
classic shoulder exercises applied to 1st group for 5 days/week for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analog scale ( VAS)
Time Frame: 6 weeks
|
pain, This scale evaluates pain verbally.
It questions the level of pain to the patients.
It is between 0 and 10 points.
O No pain, 10 means severe pain.
|
6 weeks
|
tragus-to-wall distance
Time Frame: 6 weeks
|
cervical posture, This scale measures the cervical posture, the distance between the wall and the tragus in cm.
The results vary from person to person, and increasing distance indicates that cervical posture has a poor prognosis.
|
6 weeks
|
fibromyalgia impact scale
Time Frame: 6 weeks
|
functional status, This scale evaluates functional status.
verbally questioned.
scale type is survey.
The questions asked are asked to give points between 0 and 3. 0 points always means 1 point often, 2 points sometimes, and 3 points never.
activity, doing business, and well-being.
It is stated that a high score does not affect the functional state of the disease, while a low score indicates that the disease affects the functional state.
The total score range is between 0 points and 80 points.
|
6 weeks
|
Nottingham Health Profile
Time Frame: 6 weeks
|
life quality,This scale evaluates quality of life.
questions patients' problems with pain, social isolation, emotional reaction, physical activity, energy, and sleep.
scale type is survey.
Patients are asked and their answers are recorded.
answers are yes or no.
The total score scale is in 2 parts.
The 1 section score range is between 0 and 600 points, and the 2nd section is between 0 and 7 points.
A high score indicates that the quality of life is badly affected, while a low score indicates that the quality of life is not affected.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: hakan Polat, SANKO University
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)
November 1, 2016
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
January 18, 2023
First Submitted That Met QC Criteria
January 26, 2023
First Posted (Actual)
February 2, 2023
Study Record Updates
Last Update Posted (Actual)
February 2, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HakanPolat
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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