The Effect of Manual Lymph Drainage in Fibromyalgia Patients
- Conditions
- FibromyalgiaOxidative Stress
- Interventions
- Combination Product: conservative treatment
- Registration Number
- NCT06571565
- Lead Sponsor
- Baskent University
- Brief 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.
- Detailed Description
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disorder with poorly understood pathophysiology and etiology, characterized by tender points in specific anatomical regions, often accompanied by fatigue, cognitive impairment, psychiatric symptoms, sleep disturbances and multiple somatic symptoms. FMS is a difficult disease to treat and may require the use of multifaceted treatment modalities. The main goal of treatment is to reduce pain, regulate sleep and improve physical function. There are different results in studies investigating the effectiveness of treatment modalities in FMS and there is no standardization in the methodology of these studies. In randomized controlled trials and systematic reviews, there is moderate evidence that massage improves sleep quality and reduces anxiety. In the literature, lymph drainage has been applied to these patients as a treatment method and there is limited evidence that it reduces pain.
In this randomized controlled single blinded study, our primary objective was 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 researcher working on the antioxidant panel will be blinded. The study will include female patients aged 25 years and older, who have been diagnosed with FMS for at least 2 years and whose level of medication use for FMS treatment has been stable for at least 3 months, who apply to Başkent University Adana Research and Application Center Physical Therapy and Rehabilitation clinic for fibromyalgia syndrome treatment.
Patients will be evaluated in terms of pain intensity, sleep, functional status and quality of life as well as oxidative stress and antioxidant levels in three stages: before treatment, immediately after treatment and one month after the end of treatment. Blood samples will be taken before treatment, immediately after treatment and one month after treatment for the evaluation of oxidative stress and antioxidant levels. Paraoxonase (PON1), Oxidative Stress Index (OSI), Malondialdehyde (MDA), Reduced Glutathione (GSH), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride levels will be analyzed in these blood samples.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description working group conservative treatment Conservative treatment will be applied to the back-neck region. 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. 15 sessions will be applied. Unlike the control group, manual lymph drainage treatment, the effect of which is aimed to be investigated, will be applied to the study group. Manual lymph drainage treatment will be performed by a lymphedema physiotherapist trained in Manual Lymph Drainage / Complex Unloading Physiotherapy. control group conservative treatment Conservative treatment will be applied to the back-neck region. 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. 15 sessions will be applied.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Sleep quality evaluation of Both groups will be evaluated before treatment, immediately after treatment and one month after treatment. Sleep quality will be assessed with the Pittsburgh Sleep Inventory (PSI). The PDQI is a scale that provides information about sleep quality and the type and severity of sleep disturbance in the last month.
Pain evaluation of Both groups will be evaluated before treatment, immediately after treatment and one month after treatment. Pain will be assessed with the Mcgill-Melzack pain questionnaire.
Functional Status evaluation of Both groups will be evaluated before treatment, immediately after treatment and one month after treatment. Quality of life and functional status will be assessed with the Fibromyalgia Impact Questionnaire (FEA).
Trial Locations
- Locations (1)
Baskent University
🇹🇷Adana, Çukurova, Turkey