The Effect of Manual Lymph Drainage in Fibromyalgia Patients

Baskent University

Status and phase: Invitation-only; Early Phase 1

Conditions: Fibromyalgia; Oxidative Stress

Treatments: Combination Product: conservative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06571565

PDANALAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

working group

Experimental group

Description:

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.

Treatment:

Combination Product: conservative treatment

control group

Active Comparator group

Description:

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.

Treatment:

Combination Product: conservative treatment