FibromyalgiaNCT06253416
Assessment of Muscle Thickness in Patients With Fibromyalgia
A study testing Exercise in people with Fibromyalgia, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the muscle thickness in patients with fibromyalgia (FMS) and whether there is an increase in muscle thickness, strength, and function with stretching and strengthening exercise therapy in FMS patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2023to 20 Jan 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients
- aged 18 to 65 years
- who were diagnosed with FMS according to the 2016 American College of Rheumatology (ACR) classification criteria
Who cannot join
- Patients who have a neurological or orthopedic disease that will prevent ambulation,
- advanced heart failure, kidney failure, liver failure, pulmonary diseases that will prevent exercise,
- inflammatory rheumatoid disease,
- pregnancy, breastfeeding, malignancy, psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Muscle Thickness in Patients With Fibromyalgia and to Determine the Effectiveness of Stretching and Strengthening Exercises: a Randomized Controlled Trial
To investigate the muscle thickness in patients with fibromyalgia (FMS) and whether there is an increase in muscle thickness, strength, and function with stretching and strengthening exercise therapy in FMS patients.
Read the detailed description
Fibromyalgia syndrome (FMS) is a common non-inflammatory disease characterized by musculoskeletal pain and is often seen in women between the ages of 40-60. Fatigue, weakness, sleep problems, depression, anxiety, and various cognitive and somatic disorders can be accompanied with widespread pain. Etiology and pathophysiology are still not clarified today. Multifactorial etiology could play a role in FMS pathogenesis. Genetic, environmental, biochemical, neuroendocrinological, psychological, muscular, peripheral/central/ autonomic nervous system, sleep disorders, immunological, and infectious factors can be suggested. Fibromyalgia is the most common rheumatological disorder after osteoarthritis in the general population and affects 2 % of the general population.
A decrease in muscle blood flow and oxygenation has been found in patients with FMS. Low levels of phosphocreatine, adenosine triphosphate and adenosine diphosphate have been observed at the sensitive point of the trapezius muscle of patients with FMS; increase in adenosine monophosphate and high creatine levels, and damage in muscle fibrils have been observed. Blood flow in muscles was measured at the time of exercise and a significant decrease was found in patients with FMS compared to healthy ones. This suggests to us that there is a relationship between symptoms and skeletal muscles in patients with FMS.
Exercise has the highest level of evidence and effective in the treatment of FMS. Most of the patients diagnosed with FMS are sedentary and their aerobic capacity is below average. According to the European League Against Rheumatism (EULAR) recommendations, exercise is definitely recommended in patients with FMS. Aerobic exercises, strengthening exercises, and stretching exercises have been shown to be beneficial. However, there is no definitive recommendation regarding the choice of exercise. The superiority of exercise types over each other is unclear. It is considered that aerobic and strengthening exercises will correct metabolic changes in muscle tissue and lead to a reduction in muscle pain, stretching and relaxation exercises reduce pain by reducing tension in soft tissues with.
The most common symptom after pain in patients with FMS is fatigue. Due to pain and fatigue, physical activity levels and muscle functions decrease. The loss of muscle function in young women is a major socioeconomic problem.
In our study, our goal is to investigate the muscle thickness and whether there is an increase in muscle thickness, muscle strength, and muscle function with stretching and strengthening exercise therapy in women with FMS.
The sample size was calculated as 30 patients for each group according to the results obtained from the power analysis (power=0.85; α=0.05; effect size= 0.70) performed with the G*Power version 3.1 program based on the values, taking into account the previous study Kapuczinski A. et al.
- Conditions
- Fibromyalgia
- Being tested
- Exercise, Control
- Keywords
- Fibromyalgia, ultrasonography, muscle thickness, exercises
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
a home exercise program consist of stretching and strengthening exercises , 5 repetitions of each exercise three days a week for 12 weeks
ControlOther
exercise freely and without supervision with their daily routine
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Active comparator | The exercise group was received a home exercise program consist of stretching and strengthening exercises, which was demonstrated by a physiotherapist and supported by visual cards. The exercises were shown to the patients in practice for at least 5 repetitions three days a week for 12 weeks. The exercise tracking form was given to the patients. The patients were called by the physiotherapist every week by telephone, and were allowed to fill out the exercise tracking form and adapt to exercise. Once every four weeks, patients were called to the hospital a total of three times and exercises were shown again in practice. Exercises started with stretching exercises; for ten seconds for three times with ten seconds of rest between each exercise. After stretching exercises extremity strengthening exercises were practiced with half-kilogram weights for the upper and lower extremities, each exercise is performed ten times with ten seconds of rest. Receives: Other: Exercise |
| Control group | Active comparator | The control group was told to exercise freely and without supervision. They were advised to exercise regularly, only verbally. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
Muscle thickness was measured with ultrasound (6-12 Megahertz: Philips purewave, multi-frequency linear probe). The anterior thigh muscle thicknesses were evaluated on quadriceps femoris. The midpoint between the upper end of the patella and the anterior iliac anterior superior iliac spine has been determined while the patients were lying on their backs and the muscle thickness is measured from this point in centimeters. Measurements were made three times in order to avoid erroneous measurements. All measurements were performed by a single physician, who had experience in musculoskeletal US.
Measured: at the beginning of the study and again at the end of 12 weeks by the same physician.
Secondary outcomes (5)
pain level
The pain level of the patients was measured by Numerical Rating Scale (NRS). The pain in the NRS is marked on a scale such from 0 that there is no pain at all to 10 unbearable severity of pain by patients. Higher numbers indicate worst level of pain
Measured: at the beginning of the study and again at the end of 12 weeks by the same physician.
grip strength
The grip strength was measured with a Jamar dynamo meter (Saehan hydraulic hand dynamometer). The test was performed while the patients were sitting in a chair elbow at 90 degrees of flexion and three times with each hand, with 30 seconds of rest between trials than the mean of three trials for each hand calculated separately. This instrument has a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the grip strength of the hand is registered in kilograms.
Measured: at the beginning of the study and again at the end of 12 weeks by the same physician.
Physical performance
Physical performance was assessed with the test of five times sit to stand test (FTSST) At FTSST subjects sit down without touching the back of the chair and stand up fully for 5 times as quickly as possible, and the time was measured in seconds .
Measured: at the beginning of the study and again at the end of 12 weeks by the same physician.
Disease activity
Disease activity was evaluated with the Fibromyalgia Impact Questionnaire (FIQ). The Fibromyalgia Impact Questionnaire (FIQ) is consisting of ten items on three-factor structure with a functional, physical symptom and mental symptom domains. Each item is scored on a 11 point scale (0-10). Decreased scores indicate better disease activity. Sarmer et al. demonstrated the reliability and validity of the FIQ in the Turkish population
Measured: at the beginning of the study and again at the end of 12 weeks by the same physician.
walking speed
walking speed was assessed with 6 meters walk test (6MWT). The 6MWT, a 6-meter flat path was marked on the hospital corridor, participants walked on the path, and walking time was measured in seconds.
Measured: at the beginning of the study and again at the end of 12 weeks by the same physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start14 Jun 2023
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
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
- Model description
- prospective, randomized, single-blind, clinical study patients were randomized into two groups by a physiotherapist with sealed envelopes
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Özge Başaran, Hitit University
- Investigators
- MUSTAFA KESER, Study chair, HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253416
- Sponsor's protocol ID
- 2023-78
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the confidentiality of personal data
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Muscle Thickness in Patients With Fibromyalgia and to Determine the Effectiveness of Stretching and Strengthening Exercises: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06253416
- Acronym / sponsor ID
- 2023-78
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, ultrasonography, muscle thickness, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 12 Feb 2024 (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.
To investigate the muscle thickness in patients with fibromyalgia (FMS) and whether there is an increase in muscle thickness, strength, and function with stretching and strengthening exercise therapy in FMS patients.
Detailed description
Fibromyalgia syndrome (FMS) is a common non-inflammatory disease characterized by musculoskeletal pain and is often seen in women between the ages of 40-60. Fatigue, weakness, sleep problems, depression, anxiety, and various cognitive and somatic disorders can be accompanied with widespread pain. Etiology and pathophysiology are still not clarified today. Multifactorial etiology could play a role in FMS pathogenesis. Genetic, environmental, biochemical, neuroendocrinological, psychological, muscular, peripheral/central/ autonomic nervous system, sleep disorders, immunological, and infectious factors can be suggested. Fibromyalgia is the most common rheumatological disorder after osteoarthritis in the general population and affects 2 % of the general population.
A decrease in muscle blood flow and oxygenation has been found in patients with FMS. Low levels of phosphocreatine, adenosine triphosphate and adenosine diphosphate have been observed at the sensitive point of the trapezius muscle of patients with FMS; increase in adenosine monophosphate and high creatine levels, and damage in muscle fibrils have been observed. Blood flow in muscles was measured at the time of exercise and a significant decrease was found in patients with FMS compared to healthy ones. This suggests to us that there is a relationship between symptoms and skeletal muscles in patients with FMS.
Exercise has the highest level of evidence and effective in the treatment of FMS. Most of the patients diagnosed with FMS are sedentary and their aerobic capacity is below average. According to the European League Against Rheumatism (EULAR) recommendations, exercise is definitely recommended in patients with FMS. Aerobic exercises, strengthening exercises, and stretching exercises have been shown to be beneficial. However, there is no definitive recommendation regarding the choice of exercise. The superiority of exercise types over each other is unclear. It is considered that aerobic and strengthening exercises will correct metabolic changes in muscle tissue and lead to a reduction in muscle pain, stretching and relaxation exercises reduce pain by reducing tension in soft tissues with.
The most common symptom after pain in patients with FMS is fatigue. Due to pain and fatigue, physical activity levels and muscle functions decrease. The loss of muscle function in young women is a major socioeconomic problem.
In our study, our goal is to investigate the muscle thickness and whether there is an increase in muscle thickness, muscle strength, and muscle function with stretching and strengthening exercise therapy in women with FMS.
The sample size was calculated as 30 patients for each group according to the results obtained from the power analysis (power=0.85; α=0.05; effect size= 0.70) performed with the G*Power version 3.1 program based on the values, taking into account the previous study Kapuczinski A. et al.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- prospective, randomized, single-blind, clinical study patients were randomized into two groups by a physiotherapist with sealed envelopes
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Active comparator | Other: ExerciseThe exercise group was received a home exercise program consist of stretching and strengthening exercises, which was demonstrated by a physiotherapist and supported by visual cards. The exercises were shown to the patients in practice for at least 5 repetitions three days a week for 12 weeks. The exercise tracking form was given to the patients. The patients were called by the physiotherapist every week by telephone, and were allowed to fill out the exercise tracking form and adapt to exercise. Once every four weeks, patients were called to the hospital a total of three times and exercises were shown again in practice. Exercises started with stretching exercises; for ten seconds for three times with ten seconds of rest between each exercise. After stretching exercises extremity strengthening exercises were practiced with half-kilogram weights for the upper and lower extremities, each exercise is performed ten times with ten seconds of rest. |
| Control group | Active comparator | Other: ControlThe control group was told to exercise freely and without supervision. They were advised to exercise regularly, only verbally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patients
- aged 18 to 65 years
- who were diagnosed with FMS according to the 2016 American College of Rheumatology (ACR) classification criteria
Key exclusion criteria (4 listed)
- Patients who have a neurological or orthopedic disease that will prevent ambulation,
- advanced heart failure, kidney failure, liver failure, pulmonary diseases that will prevent exercise,
- inflammatory rheumatoid disease,
- pregnancy, breastfeeding, malignancy, psychiatric illness
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 |
|---|---|---|
| Exercisea home exercise program consist of stretching and strengthening exercises , 5 repetitions of each exercise three days a week for 12 weeks | Other | Exercise group |
| Controlexercise freely and without supervision with their daily routine | Other | Control group |
Primary outcome
Muscle thickness
Time frame: at the beginning of the study and again at the end of 12 weeks by the same physician.
Muscle thickness was measured with ultrasound (6-12 Megahertz: Philips purewave, multi-frequency linear probe). The anterior thigh muscle thicknesses were evaluated on quadriceps femoris. The midpoint between the upper end of the patella and the anterior iliac anterior superior iliac spine has been determined while the patients were lying on their backs and the muscle thickness is measured from this point in centimeters. Measurements were made three times in order to avoid erroneous measurements. All measurements were performed by a single physician, who had experience in musculoskeletal US.
5 secondary outcomes
pain level
Time frame: at the beginning of the study and again at the end of 12 weeks by the same physician.
grip strength
Time frame: at the beginning of the study and again at the end of 12 weeks by the same physician.
Physical performance
Time frame: at the beginning of the study and again at the end of 12 weeks by the same physician.
Disease activity
Time frame: at the beginning of the study and again at the end of 12 weeks by the same physician.
walking speed
Time frame: at the beginning of the study and again at the end of 12 weeks by the same physician.
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 14 Feb 2024.
- Individual participant dataSharing planned: No. Due to the confidentiality of personal data
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
MUSTAFA KESER study chair
HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Fibromyalgia, run by Hitit University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Muscle thickness (time frame: at the beginning of the study and again at the end of 12 weeks by the same physician.). 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 14 Feb 2024.