Comparison of the Effects of Fibromyalgia Syndrome

NCT07082166 | Not Yet Recruiting

• 1 other identifier: ISTANBUL-UC-MAZI
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

FIBROMYALGIA SYNDROME; Connective Tissue Massage; Extracorporeal Shock Wave Therapy; Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  6 WEEK

Secondary Outcomes (1)

• Fibromyalgia Impact Questionnaire

  6 week

Study Arms (1)

CTM GROUP

ESWT GROUP

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients residing in Istanbul who applied to our center, both employed and unemployed, were included

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Gerontechnology Research Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

İlknur Mazı Mazı, PhD Student

CONTACT

+905417319232; ilknur.mazi@iuc.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 24, 2025
• Study Start: October 20, 2025
• Primary Completion: April 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)