Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia (EMLDIPWF)

August 29, 2023 updated by: Camilo Jose Cela University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28692
        • Juan Antonio Valera-Calero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women with diagnosis of Fibromyalgia.

Exclusion Criteria:

  • Women with heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
Experimental: Manual Lymphatic Drainage
Other: Manual Lymphatic Drainage
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain pressure threshold
Time Frame: Baseline
Kg/cm2
Baseline
Pain pressure threshold
Time Frame: Immediately after the intervention
Kg/cm2
Immediately after the intervention
Pain pressure threshold
Time Frame: Up to 15 days
Kg/cm2
Up to 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: Baseline
0-10
Baseline
Visual Analogue Scale
Time Frame: Immediately after the intervention
0-10
Immediately after the intervention
Visual Analogue Scale
Time Frame: Up to 15 days
0-10
Up to 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Camilo Jose Cela University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 21, 2021

Study Registration Dates

First Submitted

April 24, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CamiloJcUFM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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