Manual Lymphatic Drainage in Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Lymphatic Drainage
Medical treatment
Sham Manual Lymphatic Drainage
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, pain, manual lymphatic drainage
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
Sites / Locations
- Kutahya Health Sciences University Evliya Celebi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Manual Lymphatic Drainage Group
Sham Group
Arm Description
Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Sham Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire (FIQ)
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes.
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).
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.
Secondary Outcome Measures
Concerns About Pain
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.
Full Information
NCT ID
NCT05436314
First Posted
June 23, 2022
Last Updated
December 5, 2022
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT05436314
Brief Title
Manual Lymphatic Drainage in Fibromyalgia Syndrome
Official Title
The Effectiveness of Manual Lymphatic Drainage in Fibromyalgia Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
March 25, 2023 (Anticipated)
Study Completion Date
May 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, pain, manual lymphatic drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual Lymphatic Drainage Group
Arm Type
Experimental
Arm Description
Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Sham Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group.
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic Drainage
Intervention Description
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
Drug
Intervention Name(s)
Medical treatment
Intervention Description
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
Other
Intervention Name(s)
Sham Manual Lymphatic Drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes.
Time Frame
5 minutes
Title
Pressure pain thresholds (PPT)
Description
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).
Time Frame
10 minutes
Title
Visual Analogue Scale
Description
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.
Time Frame
1 minutes
Secondary Outcome Measure Information:
Title
Concerns About Pain
Description
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.
Time Frame
5 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze KURT, PhD
Phone
00902742652031
Ext
1419
Email
gamze.kurt@ksbu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
İSMAİL SARAÇOĞLU, Ph.D.
Phone
+905058414662
Email
ismail.saracoglu@ksbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze KURT, Ph.D.
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kutahya Health Sciences University Evliya Celebi Hospital
City
Kutahya
ZIP/Postal Code
43100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merve A LEBLEBİCİER, MD.
Phone
+905052972611
Email
merve1985akdeniz@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gamze KURT, Ph.D.
First Name & Middle Initial & Last Name & Degree
Humeyra KİLOATAR, Ph.D.
First Name & Middle Initial & Last Name & Degree
İSMAİL SARAÇOĞLU, Ph.D.
First Name & Middle Initial & Last Name & Degree
Merve AKDENİZ LEBLEBİCİER, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Manual Lymphatic Drainage in Fibromyalgia Syndrome
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