NCT04865523

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

May 7, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

April 24, 2021

Last Update Submit

August 29, 2023

Conditions

Fibromyalgia

Keywords

Manual Lymphatic DrainageRandomized clinical trialPain

Outcome Measures

Primary Outcomes (3)

  • Pain pressure threshold

    Kg/cm2

    Baseline

  • Pain pressure threshold

    Kg/cm2

    Immediately after the intervention

  • Pain pressure threshold

    Kg/cm2

    Up to 15 days

Secondary Outcomes (3)

  • Visual Analogue Scale

    Baseline

  • Visual Analogue Scale

    Immediately after the intervention

  • Visual Analogue Scale

    Up to 15 days

Study Arms (2)

Manual Lymphatic Drainage

EXPERIMENTAL
Other: Manual Lymphatic Drainage

No intervention

NO INTERVENTION

Interventions

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.

Manual Lymphatic Drainage

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMore Frequently
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with diagnosis of Fibromyalgia.

You may not qualify if:

  • Women with heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Antonio Valera-Calero

Madrid, 28692, Spain

Location

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2021

First Posted

April 29, 2021

Study Start

May 7, 2021

Primary Completion

July 1, 2021

Study Completion

July 21, 2021

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)