Comparison of the Effects of Fibromyalgia Syndrome

NCT ID: NCT07082166

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2026-06-12

Brief 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. 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.

Conditions

Fibromyalgia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

CTM GROUP

ESWT GROUP

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Ilknur Mazı

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Gerontechnology Research Center

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

İlknur Mazı Mazı, PhD Student

Role: CONTACT

ilknur.mazi@iuc.edu.tr

+905417319232

Other Identifiers

ISTANBUL-UC-MAZI

Identifier Type: -

Identifier Source: org_study_id