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Clinical Trials in Turkey / NCT06571565
Enrolling by invitation Early Phase 1

The Effect of Manual Lymph Drainage in Fibromyalgia Patients

NCT06571565 · tracked via the Priya Life Science Turkey tracker
Sponsor
Baskent University
Phase
Early Phase 1
Started
2023-12-27
Last updated
2024-09-23

Condition(s) studied

FibromyalgiaOxidative Stress

Investigational drug(s) / intervention(s)

conservative treatment

conservative treatment: Conservative treatment will be applied to the back-neck region in both groups. In this treatment, 20 min hotpack, 10 min ultrasound agent (frequency 0.5-3.5MHz), 20 min Transcutaneous Electrical Nerve Stimulation (TENS) agent (Conventional TENS; Frequency 60-80 Hz, current passage time 50-100 microseconds) will be given.

Study summary

In this randomized controlled single blinded study, our primary objective is to evaluate the effects of manual lymphatic drainage on blood lipid peroxidation system and antioxidant system in FMS patients. For this objective, the following biochemical analyses will be performed to objectively evaluate the effect of manual lymphatic drainage.

Our secondary objective is to evaluate the changes in pain, functional status and sleep quality with manual lymphatic drainage treatment. The evaluator and the investigator working on the antioxidant panel will be blinded.

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female patients aged 25 years and older who have been admitted to the Physical Therapy and Rehabilitation clinic for the treatment of fibromyalgia syndrome, who have been diagnosed with FMS for at least 2 years and whose medication use level for FMS treatment has been stable for at least 3 months will be included. Exclusion Criteria: * The exclusion criteria were determined as follows: Patients with concomitant decompensated and/or acute cardiovascular disease, scar tissue that disrupts the integrity of the skin in the area of application (back-neck), use of psychiatric medication (recently started or ongoing psychiatric medical treatment for less than 3 months, antipsychotic treatment that has not yet reached the therapeutic dose), acute infection of bacterial or viral origin. In addition, people with uncontrolled additional rheumatologic diseases that may affect the patient's pain, sleep, functional status and anti-oxidant biochemical parameters, and people with endocrinometabolic diseases such as hypothyroidism, which may change the soft tissue structure in the treatment area and cause edema, will be excluded from the study.

Primary outcome measure(s)

  • oxidative stress and other biochemical analyzes — Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
    To evaluate the effects of manual lymphatic drainage on blood lipid peroxidation system and antioxidant system in FMS patients. For this objective, the following biochemical analyses will be performed to objectively evaluate the effect of manual lymphatic drainage.Blood samples will be taken from the patients before, after and one month after the end of treatment and Paraoxonase (PON1), Oxidative Stress Index (OSI), malondialdehyde (MDA), Rductegulutathione (GSH), Low danditelilipoprotein (LDL), High danditelilipoprotein (HDL) and Triglyceride levels will be evaluated.

Trial sites (1)

FacilityCityRegionStatus
Baskent University Adana çukurova

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06571565 on ClinicalTrials.gov ↗ ← All trials in Turkey