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Manual Lymphatic Drainage in Fibromyalgia Syndrome

Not Applicable
Completed
Conditions
Fibromyalgia
Interventions
Other: Manual Lymphatic Drainage
Drug: Medical treatment
Other: Sham Manual Lymphatic Drainage
Registration Number
NCT05436314
Lead Sponsor
Kutahya Health Sciences University
Brief Summary

There are limited studies on the use of Manual Lymphatic Drainage (MLD) in fibromyalgia syndrome. Considering the possible mechanisms of action of MLD and the pathophysiology of fibromyalgia, more studies are needed to fully determine the effect of MLD on this syndrome. The aim of this study was to investigate the effectiveness of manual lymphatic drainage on symptom severity, pain intensity, pressure pain threshold and anxiety about pain in fibromyalgia syndrome.

Detailed Description

Fibromyalgia Syndrome (FMS) is a syndrome of unknown cause, characterized by numerous symptoms such as chronic widespread pain, fatigue, insomnia, joint stiffness, depression, concentration and memory problems, myofascial pain and tender points. The prevalence of FMS in the general population is 2%, and it is a common syndrome. There are studies showing that there is dysfunction in the connective tissue or fascia in FMS that triggers peripheral nociceptor stimulation. Any change in fascial tissue motility can cause an imbalance between body fluids leading to tissue hardening and accumulation of toxins. By stimulating the lymph vessels, metabolic waste products can be eliminated, excess fluid can be reduced, blockages can be removed and the immunological system can be regulated. Pharmacological and non-pharmacological methods are used in the treatment of FMS. Exercise, manual therapy techniques, cognitive behavioral treatments, patient education and other physiotherapy modalities are the non-pharmacological methods that are frequently used. Manual lymphatic drainage (MLD) was developed in 1965 by Dr. It is a manual therapy technique that consists of slow, rhythmic, superficial and repetitive movements defined by Vodder. Many effects that MLD can reveal locally and systemically are discussed. MLD; It stimulates the lymphatic and parasympathetic system, reduces pain, helps regulate the immune system, clears blockages, eliminates metabolic wastes and toxins in the body, and reduces excess fluid. There are limited studies on the use of MLD in fibromyalgia syndrome. Considering the possible mechanisms of action of MLD and the pathophysiology of fibromyalgia, more studies are needed to fully determine the effect of MLD on this syndrome. The aim of this study was to investigate the effectiveness of manual lymphatic drainage on symptom severity, pain intensity, pressure pain threshold and anxiety about pain in fibromyalgia syndrome.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
20
Inclusion Criteria
  • have fibromyalgia as defined by the criteria of the 2016 ACR
  • have Turkish as their native language
  • between 18 and 65 years of age
Exclusion Criteria
  • Having cognitive impairment
  • Receiving routine physiotherapy and/or manual therapy, alternative/complementary therapies
  • Illiterate people
  • Diagnosed with endocrine, neuromuscular, infectious and inflammatory diseases
  • Diagnosed severe mental and psychological disorders
  • Having malignancy
  • Pregnant or people who breastfeed

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Manual Lymphatic Drainage GroupMedical treatmentManual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Sham GroupMedical treatmentSham Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Sham GroupSham Manual Lymphatic DrainageSham Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Manual Lymphatic Drainage GroupManual Lymphatic DrainageManual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Primary Outcome Measures
NameTimeMethod
Fibromyalgia Impact Questionnaire (FIQ)5 minutes

The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes.

Pressure pain thresholds (PPT)10 minutes

Pressure pain thresholds in following three points, 7th cervical vertebra,6th thoracal vertebra and 3th lumbal vertebra were measured using a analog pressure algometer (Baseline, USA).

Visual Analogue Scale1 minutes

A 0-100mm Visual Analogue Scale (VAS) will be used to assess pain intensity. The VAS is a scale on a straight line with a value of "0" indicating "no pain intensity" and a value of "100" indicating "severe pain". Participants will be asked to mark the pain they feel on this line.

Secondary Outcome Measures
NameTimeMethod
Concerns About Pain5 minutes

Participants' concerns about painwill be evaluated with the "Washington University Pain-Related Worries Scale (UWCAP-TR)", which was recently developed as a pain self-efficacy measure based on modern scale development approaches and adapted into Turkish by Saraçoğlu et al. UWCAP-TR consists of 8 questions and 2 parts. While the first part of the scale evaluates concerns about pain, the second part evaluates the individual's self-confidence in the face of pain. The scores of each section are collected and evaluated separately. Scoring of the scale is done with a 5-point Likert type scale. The first part is scored between 6-30, the second part is scored between 2-10. High scores on the UWCAP-TR indicate increased anxiety about pain and low confidence.

Trial Locations

Locations (1)

Kutahya Health Sciences University Evliya Celebi Hospital

🇹🇷

Kutahya, Turkey

Kutahya Health Sciences University Evliya Celebi Hospital
🇹🇷Kutahya, Turkey

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