FibromyalgiaFMNCT00635895
Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients
A study testing Manual Lymph Drainage Therapy and Connective Tissue Massage in people with Fibromyalgia, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The present study was designed to analyze and compare the effects of Manual Lymph Drainage Therapy and Connective Tissue Massage in females with Fibromyalgia (FM). Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Manual Lymph Drainage Therapy and Connective Tissue Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2006to Oct 2007
- 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 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female outpatients
- being ≥ 25 years or older
- being met the criteria for FM as defined by the American College of Rheumatology
- having pain with the onset at least 3 months before baseline visit
- pain in the neck or shoulder region
- have never been treated for FM
- being volunteer for participating
Who cannot join
- pain from traumatic injury or structural or regional rheumatic disease,
- chronic infection,
- fever or an increased tendency to bleed,
- severe physical impairment,
- signs of tendinitis,
- cardiopulmonary disorder,
Show all 14Show fewer
- inflammatory arthritis,
- autoimmune disease,
- uncontrolled endocrine disorder,
- allergic disorder,
- pregnancy or breast-feeding,
- malignancy,
- unstable medical or psychiatric illness or medication usage.
- They were asked not to use antidepressant, myorelaxant, and non-steroid anti-inflammatory drugs during three days before the first appointment and the treatment sessions and the evaluation process after the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Manual Lymph Drainage Therapy and Connective Tissue Massage in Females With Fibromyalgia: A Randomized Controlled Trial
The present study was designed to analyze and compare the effects of Manual Lymph Drainage Therapy and Connective Tissue Massage in females with Fibromyalgia (FM).
Read the detailed description
The lack of specific disease mechanisms is reflected in the fact that no cure has been found for the disease. Thus, the many interventions which are advocated in FM are targeted against the more general characteristics of pain and disability. Current pharmacological interventions have limited efficacy. There is an increasing consensus that therapy should also include non-pharmacological approaches. Manual therapy techniques are composed of a variety of procedures directed at the musculoskeletal structures in the treatment of pain. Two major subcategories exist that divide these techniques into those which produce joint motion and those which do not. The first subcategory includes manipulation, mobilization, and manual traction. The second subcategory involves both generalized soft tissue therapies, such as the many types of massage, and focal soft tissue therapy (10).
Consequently, there is currently no recognized effective treatment for FM patients. In addition, there is limited number of study dealing with the effect of manual therapy techniques on FM. Although, there were some studies about Manual Lymph Drainage Therapy (MLDT) and Connective Tissue Massage (CTM) in FM. There wasn't found any study concerning the comparison of the effects of MLDT and CTM. In this study, MLDT and CTM were used for FM, which are included in the second subcategory of manual therapy techniques.
Based on positive results of some studies about MLDT and CTM in FM, this study was planned to test and compare the effects of MLDT and CTM in terms of pain, health status and HRQoL in females with FM using a randomized control trial.
- Conditions
- Fibromyalgia
- Being tested
- Manual Lymph Drainage Therapy and Connective Tissue Massage
- Keywords
- Fibromyalgia, Manual Lymphatic Drainage, Connective Tissue Massage, Pain, Health Related Quality of Life, Randomized Controlled Trial
- 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 Lymph Drainage Therapy and Connective Tissue MassageOther
Also called No drug was used
The treatment program was carried out five times a week, during a 3-week period for both Manual Lymph Drainage Therapy and Connective Tissue Massage groups
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Manual Lymph Drainage Therapy is a manual therapy method Receives: Other: Manual Lymph Drainage Therapy and Connective Tissue Massage |
| 2 | Active comparator | Connective Tissue Massage Receives: Other: Manual Lymph Drainage Therapy and Connective Tissue Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity VAS
Measured: 1 minute
Secondary outcomes (3)
Fibromyalgia Impact Questionnaire (FIQ)
Measured: 10 minutes
algometry
Measured: 1 munute
Nottingham Health Profile
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJun 2006
- Primary completionSep 2007
- Study completionOct 2007
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 Pamukkale 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Abant Izzet Baysal University
- Investigators
- Gamze Ekici, PhD, Principal investigator, Pamukkale UniversityYesim Bakar, Asist. Prof., Study director, Abant Izzet Baysal UniversityTurkan Akbayrak, Assoc.Prof., Study director, Hacettepe UniversityInci Yuksel, Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635895
- Sponsor's protocol ID
- Ekici - 3
- Other IDs
- ISRCTN12345678
- Acronym
- FM
- Status last verified
- Mar 2008
- First submitted
- 6 Mar 2008
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Lymph Drainage Therapy and Connective Tissue Massage in Females With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00635895
- Acronym / sponsor ID
- FM / Ekici - 3
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Manual Lymphatic Drainage, Connective Tissue Massage, Pain, Health Related Quality of Life, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University, Abant Izzet Baysal University
- Study start
- Jun 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 14 Mar 2008 (estimated)
- 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.
The present study was designed to analyze and compare the effects of Manual Lymph Drainage Therapy and Connective Tissue Massage in females with Fibromyalgia (FM).
Detailed description
The lack of specific disease mechanisms is reflected in the fact that no cure has been found for the disease. Thus, the many interventions which are advocated in FM are targeted against the more general characteristics of pain and disability. Current pharmacological interventions have limited efficacy. There is an increasing consensus that therapy should also include non-pharmacological approaches. Manual therapy techniques are composed of a variety of procedures directed at the musculoskeletal structures in the treatment of pain. Two major subcategories exist that divide these techniques into those which produce joint motion and those which do not. The first subcategory includes manipulation, mobilization, and manual traction. The second subcategory involves both generalized soft tissue therapies, such as the many types of massage, and focal soft tissue therapy (10).
Consequently, there is currently no recognized effective treatment for FM patients. In addition, there is limited number of study dealing with the effect of manual therapy techniques on FM. Although, there were some studies about Manual Lymph Drainage Therapy (MLDT) and Connective Tissue Massage (CTM) in FM. There wasn't found any study concerning the comparison of the effects of MLDT and CTM. In this study, MLDT and CTM were used for FM, which are included in the second subcategory of manual therapy techniques.
Based on positive results of some studies about MLDT and CTM in FM, this study was planned to test and compare the effects of MLDT and CTM in terms of pain, health status and HRQoL in females with FM using a randomized control trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Manual Lymph Drainage Therapy and Connective Tissue MassageManual Lymph Drainage Therapy is a manual therapy method |
| 2 | Active comparator | Other: Manual Lymph Drainage Therapy and Connective Tissue MassageConnective Tissue Massage |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- female outpatients
- being ≥ 25 years or older
- being met the criteria for FM as defined by the American College of Rheumatology
- having pain with the onset at least 3 months before baseline visit
- pain in the neck or shoulder region
Key exclusion criteria (14 listed)
- pain from traumatic injury or structural or regional rheumatic disease,
- chronic infection,
- fever or an increased tendency to bleed,
- severe physical impairment,
- signs of tendinitis,
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 Lymph Drainage Therapy and Connective Tissue MassageAlso: No drug was usedThe treatment program was carried out five times a week, during a 3-week period for both Manual Lymph Drainage Therapy and Connective Tissue Massage groups | Other | 1, 2 |
Primary outcome
Pain intensity VAS
Time frame: 1 minute
3 secondary outcomes
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 10 minutes
algometry
Time frame: 1 munute
Nottingham Health Profile
Time frame: 10 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 14 Mar 2008.
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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 Ekici, PhD principal investigator
Pamukkale University
Yesim Bakar, Asist. Prof. study director
Abant Izzet Baysal University
Turkan Akbayrak, Assoc.Prof. study director
Hacettepe 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 Lymph Drainage Therapy and Connective Tissue Massage in people with Fibromyalgia, run by Pamukkale 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 7 inclusion and 14 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 14 Mar 2008. 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. 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?
Pain intensity VAS (time frame: 1 minute). 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 14 Mar 2008.