Manual Lymphatic Drainage in Fibromyalgia Syndrome

NCT05436314 | Completed

• 1 other identifier: MLDfibro
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; pain; manual lymphatic drainage

Outcome Measures

Primary Outcomes (3)

• Fibromyalgia Impact Questionnaire (FIQ)

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

  5 minutes

• Pressure pain thresholds (PPT)

  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).

  10 minutes

• Visual Analogue Scale

  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.

  1 minutes

Secondary Outcomes (1)

• Concerns About Pain

  5 minutes

Study Arms (2)

Manual Lymphatic Drainage Group

EXPERIMENTAL

Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.

Other: Manual Lymphatic Drainage; Drug: Medical treatment

Sham Group

SHAM COMPARATOR

Sham Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.

Drug: Medical treatment; Other: Sham Manual Lymphatic Drainage

Interventions

Manual Lymphatic Drainage OTHER

Manual Lymphatic Drainage (MLD) is applied towards the flow direction of lymph vessels with special hand movements. MLD is made with very light, completely painless and rhythmic translational movements of the skin. MLD, by expert and trained physiotherapists (G.K, H.K) in this field. It will be applied with the techniques defined by Dr. Vodder. MLD ( to the neck region, abdominal region, axillary and inguinal lymph nodes) will be applied by following the lymphatic pathways specific to the anterior and posterior trunk, respectively. The treatment session will take approximately 45 minutes. It will be applied 5 days a week during 3 weeks.

Manual Lymphatic Drainage Group

Medical treatment DRUG

The patients in control group continued taking their regular gabapentin and pregabalin-derivative drug therapy at the same dosage and duration specified by their physicians.

Manual Lymphatic Drainage Group; Sham Group

Sham Manual Lymphatic Drainage OTHER

Sham MLD will be administered by MLD-trained physiotherapists (G.K, H.K) with a protocol that is far from techniques that reveal the physiological effects of MLD. Sham application consists of applications that do not follow the lymphatic pathways from distal to proximal to the trunk, neck, and abdominal region, and superficial breathing. The session will take approximately 45 minutes.

Sham Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have fibromyalgia as defined by the criteria of the 2016 ACR
• have Turkish as their native language
• between 18 and 65 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University Evliya Celebi Hospital

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gamze KURT, Ph.D.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: July 25, 2022
• Primary Completion: August 25, 2023
• Study Completion: January 15, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)