Clinical trial NCT06571565: The Effect of Manual Lymph Drainage in Fibromyalgia Patients
Official title: Manual Lymph Drainage in Fibromyalgia Patients; Oxidative Stress, Pain, Functional Effect on Mood and Sleep Quality
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Fibromyalgia
Oxidative Stress
Keywords: Fibromyalgia
manual lymph drainage
lymph
oxidative stress
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 44
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: As a randomized controlled single blind
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: oxidative stress and other biochemical analyzes
timeFrame: Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Secondary outcomes:
measure: Pain evaluation of
timeFrame: Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
measure: Functional Status evaluation of
timeFrame: Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
measure: Sleep quality evaluation of
timeFrame: Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University
state: Çukurova
Study officials:
affiliation: dr
name: Selen OZGOZEN, Dr
role: STUDY_CHAIR
References:
citation: Bennett RM, Friend R, Marcus D, Bernstein C, Han BK, Yachoui R, Deodhar A, Kaell A, Bonafede P, Chino A, Jones KD. Criteria for the diagnosis of fibromyalgia: validation of the modified 2010 preliminary American College of Rheumatology criteria and the development of alternative criteria. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1364-73. doi: 10.1002/acr.22301.
citation: Heidari F, Afshari M, Moosazadeh M. Prevalence of fibromyalgia in general population and patients, a systematic review and meta-analysis. Rheumatol Int. 2017 Sep;37(9):1527-1539. doi: 10.1007/s00296-017-3725-2. Epub 2017 Apr 26.