Completed

FMStudy of the Effectiveness of a Neurodynamic Intervention in Women With Fibromyalgia.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Placebo group

+ Neurodynamic technique group

Other
Who is being recruted

Muscular Diseases+3

+ Musculoskeletal Diseases

+ Nervous System Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorUniversidad de Granada
Last updated: October 28, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

Fibromyalgia affects women nine times more than men.The pathophysiology of fibromyalgia is being studied nowadays in order to understand the mechanisms implicated in it. The treatment propose in this study is a neurodynamic intervention. Neurodynamics is the term used to describe the integration of the morphology, biomechanics and physiology of the nervous system.

NCT01826695
Principal SponsorUniversidad de Granada
Last updated: October 28, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeuromuscular DiseasesRheumatic DiseasesFibromyalgia

Criteria

3 inclusion criteria required to participate
Female sex
Women diagnosed with Fibromyalgia attending to the Fibromyalgia Association of Granada
Women who can complete the assessment battery of tests at the beginning and at the end of the study
5 exclusion criteria prevent from participating
Auditive and visual disturbances
Cognitive problems
Male sex
Psychiatric pathology
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
35 women are recruited in order to the inclusion criteria for the study. Placebo controlled. They received only standard treatment without neurodynamic intervention. They are diagnosed with Fibromyalgia attending to the Fibromyalgia Association of Granada. The study include subjects who can complete the assessment battery of tests at the beginning and end.

Group II

Active Comparator
35 women are recruited, diagnosed with Fibromyalgia attending to the Fibromyalgia Association of Granada. The study include subjects who can complete the assessment battery of tests at the beginning and at the end.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Faculty of Health Sciences. University of Granada.

Granada, SpainOpen Faculty of Health Sciences. University of Granada. in Google Maps
CompletedOne Study Center