Clinical trial NCT05436314: Manual Lymphatic Drainage in Fibromyalgia Syndrome
Official title: The Effectiveness of Manual Lymphatic Drainage in Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
pain
manual lymphatic drainage
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 5 minutes
measure: Pressure pain thresholds (PPT)
timeFrame: 10 minutes
measure: Visual Analogue Scale
timeFrame: 1 minutes
Secondary outcomes:
measure: Concerns About Pain
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University Evliya Celebi Hospital
Study officials:
affiliation: Kutahya Health Sciences University
name: Gamze KURT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: