Manual Lymphatic Drainage in Fibromyalgia Syndrome

March 4, 2025 updated by: Gamze Kurt, Kutahya Health Sciences University

The Effectiveness of Manual Lymphatic Drainage in Fibromyalgia Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Kutahya, Turkey, 43100
        • Kutahya Health Sciences University Evliya Celebi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Manual Lymphatic Drainage Group
Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Other: Manual Lymphatic Drainage
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.
Drug: Medical treatment
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.
Sham Comparator: Sham Group
Sham Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Drug: Medical treatment
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.
Other: Sham Manual Lymphatic Drainage
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: 5 minutes
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes.
5 minutes
Pressure pain thresholds (PPT)
Time Frame: 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).
10 minutes
Visual Analogue Scale
Time Frame: 1 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.
1 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concerns About Pain
Time Frame: 5 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.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gamze KURT, Ph.D., Kutahya Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MLDfibro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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