FibromyalgiaEMLDIPWFNCT04865523
Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia
A study testing Manual Lymphatic Drainage in people with Fibromyalgia, run by Camilo Jose Cela University at 1 site in Spain.
Trial summary
Manual Lymphatic Drainage is a widely used technique for lymphedema. However, the analgesic effects of this technique could be potentially useful for managing pain in patients with generalized widespread chronic pain, including patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Manual Lymphatic Drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 7 May 2021to 21 Jul 2021
- 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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with diagnosis of Fibromyalgia.
Who cannot join
- Women with heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Manual Lymphatic Drainage is a widely used technique for lymphedema. However, the analgesic effects of this technique could be potentially useful for managing pain in patients with generalized widespread chronic pain, including patients with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Manual Lymphatic Drainage
- Keywords
- Manual Lymphatic Drainage, Randomized clinical trial, Pain
- 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 is a technique that through gentle passes facilitates the flow of lymph through manual therapy techniques based on Vodder therapy. This technique is being studied to know its effectiveness in pain and for this reason we want to carry out this research.
| Study group | Role | What they receive |
|---|---|---|
| Manual Lymphatic Drainage | Experimental | Not described Receives: Other: Manual Lymphatic Drainage |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Kg/cm2
Measured: Baseline
Pain pressure threshold
Kg/cm2
Measured: Immediately after the intervention
Pain pressure threshold
Kg/cm2
Measured: Up to 15 days
Secondary outcomes (3)
Visual Analogue Scale
0-10
Measured: Baseline
Visual Analogue Scale
0-10
Measured: Immediately after the intervention
Visual Analogue Scale
0-10
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start7 May 2021
- Primary completion1 Jul 2021
- Study completion21 Jul 2021
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865523
- Sponsor's protocol ID
- CamiloJcUFM
- Acronym
- EMLDIPWF
- Status last verified
- Aug 2023
- First submitted
- 24 Apr 2021
- Last updated
- 31 Aug 2023
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04865523
- Acronym / sponsor ID
- EMLDIPWF / CamiloJcUFM
- Conditions
- Fibromyalgia
- Keywords
- Manual Lymphatic Drainage, Randomized clinical trial, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 29 Apr 2021 (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.
Manual Lymphatic Drainage is a widely used technique for lymphedema. However, the analgesic effects of this technique could be potentially useful for managing pain in patients with generalized widespread chronic pain, including patients with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage | Experimental | Other: Manual Lymphatic Drainage |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with diagnosis of Fibromyalgia.
Key exclusion criteria (1 listed)
- Women with heart failure.
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 is a technique that through gentle passes facilitates the flow of lymph through manual therapy techniques based on Vodder therapy. This technique is being studied to know its effectiveness in pain and for this reason we want to carry out this research. | Other | Manual Lymphatic Drainage |
Primary outcome
Pain pressure threshold
Time frame: Baseline
Kg/cm2
Pain pressure threshold
Time frame: Immediately after the intervention
Kg/cm2
Pain pressure threshold
Time frame: Up to 15 days
Kg/cm2
3 secondary outcomes
Visual Analogue Scale
Time frame: Baseline
Visual Analogue Scale
Time frame: Immediately after the intervention
Visual Analogue Scale
Time frame: Up to 15 days
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 31 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Fibromyalgia, run by Camilo Jose Cela University at 1 site in Spain.
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 1 inclusion and 1 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 31 Aug 2023. 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 Spain. 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 pressure threshold (time frame: Baseline). 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 31 Aug 2023.