FibromyalgiaNCT05710939
Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients
A study testing exercises in people with Fibromyalgia and Exercise, Compulsive, run by Sanko University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fibromyalgia, Exercise, Compulsive, Pain
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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).
Read the 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).
- Conditions
- Fibromyalgia, Exercise, Compulsive, Pain, Postural; Defect
- Being tested
- exercises
- Medical subject headings
- Fibromyalgia, Compulsive Exercise, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| scapular stabilization exercises | Active comparator | scapular stabilization exercises applied to 1st group for 5 days/week for 6 weeks Receives: Other: exercises |
| classic shoulder exercises | Active comparator | classic shoulder exercises applied to 1st group for 5 days/week for 6 weeks Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale ( VAS)
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.
Measured: 6 weeks
tragus-to-wall distance
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.
Measured: 6 weeks
fibromyalgia impact scale
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.
Measured: 6 weeks
Nottingham Health Profile
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Nov 2016
- Primary completion1 Feb 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Polat, Sanko University
- Investigators
- hakan Polat, Study director, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710939
- Sponsor's protocol ID
- HakanPolat
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT05710939
- Acronym / sponsor ID
- HakanPolat
- Conditions
- Fibromyalgia, Exercise, Compulsive, Pain, Postural; Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scapular stabilization exercises | Active comparator | Other: exercisesscapular stabilization exercises applied to 1st group for 5 days/week for 6 weeks |
| classic shoulder exercises | Active comparator | Other: exercisesclassic shoulder exercises applied to 1st group for 5 days/week for 6 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercises | Other | classic shoulder exercises, scapular stabilization exercises |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hakan Polat study director
Sanko University
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Fibromyalgia and Exercise, Compulsive, run by Sanko University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale ( VAS) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.