Manual Lymphatic Drainage in Fibromyalgia Syndrome

NCT ID: NCT05436314

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2024-01-15

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual Lymphatic Drainage Group

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

Group Type: EXPERIMENTAL

Manual Lymphatic Drainage

Intervention Type: 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.

Medical treatment

Intervention Type: 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.

Sham Group

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

Group Type: SHAM_COMPARATOR

Medical treatment

Intervention Type: 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.

Sham Manual Lymphatic Drainage

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kutahya Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Kurt

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamze KURT, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

Locations

Kutahya Health Sciences University Evliya Celebi Hospital

Kütahya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MLDfibro

Identifier Type: -

Identifier Source: org_study_id