FibromyalgiaNCT05436314
Manual Lymphatic Drainage in Fibromyalgia Syndrome
A study testing Manual Lymphatic Drainage and Medical treatment in people with Fibromyalgia, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Manual Lymphatic Drainage and Medical treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have fibromyalgia as defined by the criteria of the 2016 ACR
- have Turkish as their native language
- between 18 and 65 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University Evliya Celebi Hospital
Kütahya, 43100
About this study
Official title: 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.
Read the 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
- Being tested
- Manual Lymphatic Drainage, Medical treatment, Sham Manual Lymphatic Drainage
- Keywords
- fibromyalgia, pain, manual lymphatic drainage
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic DrainageOther
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 treatmentDrug
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 DrainageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Lymphatic Drainage Group | Experimental | Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group. Receives: 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. Receives: Drug: Medical treatment; Other: Sham Manual Lymphatic Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes.
Measured: 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).
Measured: 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.
Measured: 1 minutes
Secondary outcomes (1)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start25 Jul 2022
- Primary completion25 Aug 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Kurt, Kutahya Health Sciences University
- Investigators
- Gamze KURT, Ph.D., Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436314
- Sponsor's protocol ID
- MLDfibro
- Status last verified
- Mar 2025
- First submitted
- 23 Jun 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Manual Lymphatic Drainage in Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT05436314
- Acronym / sponsor ID
- MLDfibro
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, pain, manual lymphatic drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage Group | Experimental | Other: Manual Lymphatic Drainage, Drug: Medical treatmentManual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group. |
| Sham Group | Sham comparator | Drug: Medical treatment, Other: Sham Manual Lymphatic DrainageSham Manual Lymphatic Drainage (MLD) in addition to medical treatment is applied to participants in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have fibromyalgia as defined by the criteria of the 2016 ACR
- have Turkish as their native language
- between 18 and 65 years of age
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Lymphatic DrainageManual 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. | Other | Manual Lymphatic Drainage Group |
| Medical treatmentThe patients in control group continued taking their regular gabapentin and pregabalin-derivative drug therapy at the same dosage and duration specified by their physicians. | Drug | Manual Lymphatic Drainage Group, Sham Group |
| Sham Manual Lymphatic DrainageSham 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. | Other | Sham Group |
Primary outcome
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.
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).
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 secondary outcome
Concerns About Pain
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze KURT, Ph.D. principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic Drainage and Medical treatment in people with Fibromyalgia, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.