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The Effect of Manual Lymph Drainage in Fibromyalgia Patients

Manual Lymph Drainage in Fibromyalgia Patients; Oxidative Stress, Pain, Functional Effect on Mood and Sleep Quality

Status
Enrolling by invitation
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06571565
Enrollment
44
Registered
2024-08-26
Start date
2023-12-27
Completion date
2026-12-31
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Oxidative Stress

Keywords

Fibromyalgia, manual lymph drainage, lymph, oxidative stress

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.

Interventions

COMBINATION_PRODUCTconservative 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.

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

The evaluator and the researcher working on the antioxidant panel will be blinded.

Intervention model description

As a randomized controlled single blind

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
oxidative stress and other biochemical analyzesBoth 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

MeasureTime frameDescription
Pain evaluation ofBoth 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 ofBoth 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).
Sleep quality evaluation ofBoth 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026