Back to resultsEffectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia (EMLDIPWF)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Lymphatic Drainage
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Manual Lymphatic Drainage, Randomized clinical trial, Pain
Eligibility Criteria
Inclusion Criteria:
- Women with diagnosis of Fibromyalgia.
Exclusion Criteria:
- Women with heart failure.
Sites / Locations
- Juan Antonio Valera-Calero
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Manual Lymphatic Drainage
No intervention
Arm Description
Outcomes
Primary Outcome Measures
Pain pressure threshold
Kg/cm2
Pain pressure threshold
Kg/cm2
Pain pressure threshold
Kg/cm2
Secondary Outcome Measures
Visual Analogue Scale
0-10
Visual Analogue Scale
0-10
Visual Analogue Scale
0-10
Full Information
NCT ID
NCT04865523
First Posted
April 24, 2021
Last Updated
August 29, 2023
Sponsor
Camilo Jose Cela University
1. Study Identification
Unique Protocol Identification Number
NCT04865523
Brief Title
Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia
Acronym
EMLDIPWF
Official Title
Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camilo Jose Cela 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Manual Lymphatic Drainage, Randomized clinical trial, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Lymphatic Drainage
Arm Type
Experimental
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic Drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain pressure threshold
Description
Kg/cm2
Time Frame
Baseline
Title
Pain pressure threshold
Description
Kg/cm2
Time Frame
Immediately after the intervention
Title
Pain pressure threshold
Description
Kg/cm2
Time Frame
Up to 15 days
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
0-10
Time Frame
Baseline
Title
Visual Analogue Scale
Description
0-10
Time Frame
Immediately after the intervention
Title
Visual Analogue Scale
Description
0-10
Time Frame
Up to 15 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
More Frequently
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with diagnosis of Fibromyalgia.
Exclusion Criteria:
Women with heart failure.
Facility Information:
Facility Name
Juan Antonio Valera-Calero
City
Madrid
ZIP/Postal Code
28692
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia
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