FibromyalgiaNCT07082166
Comparison of the Effects of Fibromyalgia Syndrome
An observational study of Fibromyalgia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Massage therapy, one of the complementary and alternative treatments, is commonly used for fibromyalgia syndrome (FMS). It may help improve pain, anxiety, depression, and sleep disorders through the complex interaction of physical and mental mechanisms. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2025to 12 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients residing in Istanbul who applied to our center, both employed and unemployed, were included
Who may be able to join
- Clinical diagnosis of fibromyalgia syndrome
- Aged between 18 and 60 years
- Female gender
- Symptoms present for at least 6 months
- Willing to participate in the study
- Literate
Who cannot join
- History of rheumatologic, neurologic, psychiatric, or systemic disease
- Pregnancy or lactation
- Prior treatment with massage or ESWT
- History of acute infection, trauma, or surgery
- History of cancer
- Use of painkillers or antidepressants
- Any medical condition that prevents participation in physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Gerontechnology Research Center
Istanbul
About this study
Official title: Comparison of the Effects of Connective Tissue Massage and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Fibromyalgia Syndrome
Massage therapy, one of the complementary and alternative treatments, is commonly used for fibromyalgia syndrome (FMS). It may help improve pain, anxiety, depression, and sleep disorders through the complex interaction of physical and mental mechanisms. Although studies have investigated massage and extracorporeal shock wave therapy (ESWT) separately, there is currently no study directly comparing these two treatment methods.
In this study, we plan to use massage therapy to reduce pain, stiffness, fatigue, and sleep difficulties in individuals with FMS. The aim is to evaluate the effects of both connective tissue massage and ESWT on fibromyalgia symptoms, with a focus on pain, fatigue, sleep disturbances, health status, and quality of life.
We also aim to compare the effectiveness of these two non-pharmacological interventions in enhancing general well-being and encouraging participation in daily life. Additionally, we hope this research will contribute to clinical practice by evaluating the potential benefits of connective tissue massage, a safe and cost-effective method.
Read the detailed description
General Information
Fibromyalgia syndrome (FMS) is one of the most common conditions affecting muscles and is characterized by pain, stiffness, and tenderness in muscles, tendons, and joints. Despite years of research, no definitive cause or pathophysiology of FMS has been identified. It is believed that genetic and environmental factors, as well as both peripheral and central mechanisms, may play a role in the development of widespread pain and pain sensitivity in individuals with fibromyalgia. FMS is often associated with symptoms such as decreased physical capacity, fatigue, sleep disorders, gastrointestinal issues, and psychiatric conditions including depression. Pain and other symptoms interfere with daily functioning, work, and social activities, resulting in reduced quality of life.
Various treatment approaches are available for patients with FMS. Both pharmacological and non-pharmacological methods are used in its management. Treatment options include medications such as tricyclic antidepressants, exercise, acupuncture, manual/manipulative therapies, and mind-body approaches. Studies on exercise suggest that moderate-to-high intensity physical activity may be effective. Antidepressants have been found helpful in increasing serotonin levels and thereby alleviating fibromyalgia symptoms. Chiropractic care and acupuncture have also been explored as potential management strategies.
Connective Tissue Massage (CTM) Massage therapy is widely used as a complementary and alternative treatment in fibromyalgia. Through the complex interaction of physical and psychological mechanisms, it may improve pain, anxiety, depression, and sleep disturbances. When applied to soft tissues and connective tissue, massage may induce local biochemical changes that contribute to improved muscle flexibility and modulation of local blood and lymphatic circulation.
Connective tissue massage, one of the manual therapy techniques used for FMS, involves short and long tractions on the connective tissue that may mechanically stimulate mast cells. This may help reduce sympathetic activity and promote vasodilation. As a result, parasympathetic activity increases and supports improved circulation.
Extracorporeal Shock Wave Therapy (ESWT) Extracorporeal shock wave therapy is a non-invasive physical method developed from extracorporeal shock wave lithotripsy. While initial studies focused on kidney stones, recent research on the musculoskeletal system has shown that shock waves may positively affect various tissues, including bones and soft tissues.
Materials and Methods
Participants Patients diagnosed with FMS by a rheumatologist according to ACR criteria and referred to the Department of Physiotherapy and Rehabilitation will be assessed for eligibility.
Assessment Tools Demographic and clinical information will be collected using a custom-designed form developed by the researchers. This form includes gender, age, height, weight, education level, and medical history (e.g., chronic diseases, past injuries, eating disorders). Participants will be instructed on how to complete the form, and data will be used for scientific purposes only.
Evaluation Methods
Pain will be assessed using the McGill Pain Questionnaire, which includes a scale from "no pain" to "unbearable pain" and body diagrams for pain localization.
Quality of life will be evaluated with the Nottingham Health Profile, measuring the impact of health on function and well-being.
Fibromyalgia Impact will be measured by the Fibromyalgia Impact Questionnaire, assessing physical health, work status, depression, anxiety, sleep, pain, fatigue, stiffness, and well-being. Higher scores indicate lower functioning.
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index, including components such as sleep duration, latency, medication use, and daytime functioning.
Mechanical pain sensitivity will be measured using an algometer. Pressure will be applied to tender points until the participant indicates pain. The procedure will be repeated for reliability, and pressure will be recorded in Newton/cm².
Anxiety will be evaluated using the State-Trait Anxiety Inventory, where higher scores indicate greater anxiety.
Interventions and Statistical Methods Participants will be randomly assigned to two groups. Both groups will receive treatment on the same anatomical regions. One group will receive connective tissue massage, and the other will receive extracorporeal shock wave therapy. Both groups will also engage in a walking program and posture exercises. Evaluations will be conducted at baseline, post-treatment, and at follow-up.
Treatment Protocols
Connective Tissue Massage: Administered with the patient in a prone position. Areas treated include the lumbosacral, lower thoracic, scapular, interscapular, and cervical regions. The therapist will use finger traction techniques. Sessions will last approximately 30 minutes.
Extracorporeal Shock Wave Therapy: Applied with the patient in the same position using a medical device. Parameters include defined pressure levels and a specific number of pulses per session. Sessions will be brief.
Statistical Analysis Data will be analyzed using SPSS software. Normality will be tested, and appropriate parametric or non-parametric tests will be used. Variables will be presented as means, standard deviations, confidence intervals, and percentages. Between-group differences will be analyzed with t-tests and chi-square tests. Pre- and post-treatment changes will be evaluated with paired tests. Statistical significance will be set at p < 0.05. Effect sizes will be calculated and categorized as small, medium, or large.
Power Analysis Sample size was calculated using power analysis software. Based on expected effect sizes and desired power, the required number of participants per group was determined. The final sample size was increased to account for potential dropouts.
- Conditions
- Fibromyalgia
- Keywords
- FIBROMYALGIA SYNDROME, Connective Tissue Massage, Extracorporeal Shock Wave Therapy, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CTM GROUP | ESWT GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
3.1. Pain (Mcgill)
Higher scores indicate more severe pain. Description: Consists of 15 pain descriptors (11 sensory, 4 affective), each rated on a scale from 0 (none) to 3 (severe), plus a Visual Analog Scale (VAS) and Present Pain Intensity (PPI)
Measured: 6 WEEK
Secondary outcomes (1)
Fibromyalgia Impact Questionnaire
Higher scores indicate greater disease impact and worse functional status. Description: Measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start20 Oct 2025 (estimated)
- Primary completion12 Apr 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Mazı, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082166
- Sponsor's protocol ID
- ISTANBUL-UC-MAZI
- Status last verified
- Aug 2025
- First submitted
- 13 Jul 2025
- Last updated
- 19 Aug 2025
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Connective Tissue Massage and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT07082166
- Acronym / sponsor ID
- ISTANBUL-UC-MAZI
- Conditions
- Fibromyalgia
- Keywords
- FIBROMYALGIA SYNDROME, Connective Tissue Massage, Extracorporeal Shock Wave Therapy, Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Oct 2025 (estimated)
- Primary completion
- 12 Apr 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
Massage therapy, one of the complementary and alternative treatments, is commonly used for fibromyalgia syndrome (FMS). It may help improve pain, anxiety, depression, and sleep disorders through the complex interaction of physical and mental mechanisms. Although studies have investigated massage and extracorporeal shock wave therapy (ESWT) separately, there is currently no study directly comparing these two treatment methods.
In this study, we plan to use massage therapy to reduce pain, stiffness, fatigue, and sleep difficulties in individuals with FMS. The aim is to evaluate the effects of both connective tissue massage and ESWT on fibromyalgia symptoms, with a focus on pain, fatigue, sleep disturbances, health status, and quality of life.
We also aim to compare the effectiveness of these two non-pharmacological interventions in enhancing general well-being and encouraging participation in daily life. Additionally, we hope this research will contribute to clinical practice by evaluating the potential benefits of connective tissue massage, a safe and cost-effective method.
Detailed description
General Information
Fibromyalgia syndrome (FMS) is one of the most common conditions affecting muscles and is characterized by pain, stiffness, and tenderness in muscles, tendons, and joints. Despite years of research, no definitive cause or pathophysiology of FMS has been identified. It is believed that genetic and environmental factors, as well as both peripheral and central mechanisms, may play a role in the development of widespread pain and pain sensitivity in individuals with fibromyalgia. FMS is often associated with symptoms such as decreased physical capacity, fatigue, sleep disorders, gastrointestinal issues, and psychiatric conditions including depression. Pain and other symptoms interfere with daily functioning, work, and social activities, resulting in reduced quality of life.
Various treatment approaches are available for patients with FMS. Both pharmacological and non-pharmacological methods are used in its management. Treatment options include medications such as tricyclic antidepressants, exercise, acupuncture, manual/manipulative therapies, and mind-body approaches. Studies on exercise suggest that moderate-to-high intensity physical activity may be effective. Antidepressants have been found helpful in increasing serotonin levels and thereby alleviating fibromyalgia symptoms. Chiropractic care and acupuncture have also been explored as potential management strategies.
Connective Tissue Massage (CTM) Massage therapy is widely used as a complementary and alternative treatment in fibromyalgia. Through the complex interaction of physical and psychological mechanisms, it may improve pain, anxiety, depression, and sleep disturbances. When applied to soft tissues and connective tissue, massage may induce local biochemical changes that contribute to improved muscle flexibility and modulation of local blood and lymphatic circulation.
Connective tissue massage, one of the manual therapy techniques used for FMS, involves short and long tractions on the connective tissue that may mechanically stimulate mast cells. This may help reduce sympathetic activity and promote vasodilation. As a result, parasympathetic activity increases and supports improved circulation.
Extracorporeal Shock Wave Therapy (ESWT) Extracorporeal shock wave therapy is a non-invasive physical method developed from extracorporeal shock wave lithotripsy. While initial studies focused on kidney stones, recent research on the musculoskeletal system has shown that shock waves may positively affect various tissues, including bones and soft tissues.
Materials and Methods
Participants Patients diagnosed with FMS by a rheumatologist according to ACR criteria and referred to the Department of Physiotherapy and Rehabilitation will be assessed for eligibility.
Assessment Tools Demographic and clinical information will be collected using a custom-designed form developed by the researchers. This form includes gender, age, height, weight, education level, and medical history (e.g., chronic diseases, past injuries, eating disorders). Participants will be instructed on how to complete the form, and data will be used for scientific purposes only.
Evaluation Methods
Pain will be assessed using the McGill Pain Questionnaire, which includes a scale from "no pain" to "unbearable pain" and body diagrams for pain localization.
Quality of life will be evaluated with the Nottingham Health Profile, measuring the impact of health on function and well-being.
Fibromyalgia Impact will be measured by the Fibromyalgia Impact Questionnaire, assessing physical health, work status, depression, anxiety, sleep, pain, fatigue, stiffness, and well-being. Higher scores indicate lower functioning.
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index, including components such as sleep duration, latency, medication use, and daytime functioning.
Mechanical pain sensitivity will be measured using an algometer. Pressure will be applied to tender points until the participant indicates pain. The procedure will be repeated for reliability, and pressure will be recorded in Newton/cm².
Anxiety will be evaluated using the State-Trait Anxiety Inventory, where higher scores indicate greater anxiety.
Interventions and Statistical Methods Participants will be randomly assigned to two groups. Both groups will receive treatment on the same anatomical regions. One group will receive connective tissue massage, and the other will receive extracorporeal shock wave therapy. Both groups will also engage in a walking program and posture exercises. Evaluations will be conducted at baseline, post-treatment, and at follow-up.
Treatment Protocols
Connective Tissue Massage: Administered with the patient in a prone position. Areas treated include the lumbosacral, lower thoracic, scapular, interscapular, and cervical regions. The therapist will use finger traction techniques. Sessions will last approximately 30 minutes.
Extracorporeal Shock Wave Therapy: Applied with the patient in the same position using a medical device. Parameters include defined pressure levels and a specific number of pulses per session. Sessions will be brief.
Statistical Analysis Data will be analyzed using SPSS software. Normality will be tested, and appropriate parametric or non-parametric tests will be used. Variables will be presented as means, standard deviations, confidence intervals, and percentages. Between-group differences will be analyzed with t-tests and chi-square tests. Pre- and post-treatment changes will be evaluated with paired tests. Statistical significance will be set at p < 0.05. Effect sizes will be calculated and categorized as small, medium, or large.
Power Analysis Sample size was calculated using power analysis software. Based on expected effect sizes and desired power, the required number of participants per group was determined. The final sample size was increased to account for potential dropouts.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTM GROUP | – | –ESWT GROUP |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients residing in Istanbul who applied to our center, both employed and unemployed, were included
Key inclusion criteria (6 listed)
- Clinical diagnosis of fibromyalgia syndrome
- Aged between 18 and 60 years
- Female gender
- Symptoms present for at least 6 months
- Willing to participate in the study
Key exclusion criteria (7 listed)
- History of rheumatologic, neurologic, psychiatric, or systemic disease
- Pregnancy or lactation
- Prior treatment with massage or ESWT
- History of acute infection, trauma, or surgery
- History of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3.1. Pain (Mcgill)
Time frame: 6 WEEK
Higher scores indicate more severe pain. Description: Consists of 15 pain descriptors (11 sensory, 4 affective), each rated on a scale from 0 (none) to 3 (severe), plus a Visual Analog Scale (VAS) and Present Pain Intensity (PPI)
1 secondary outcome
Fibromyalgia Impact Questionnaire
Time frame: 6 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Istanbul University - Cerrahpasa 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlknur Mazı Mazı, PhD Student (+905417319232, ilknur.mazi@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3.1. Pain (Mcgill) (time frame: 6 WEEK). 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 19 Aug 2025.