Neurodynamic Intervention in Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Placebo group; Other: Neurodynamic technique group

• Registration Number: NCT01826695
• Lead Sponsor: Universidad de Granada

Brief Summary

Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population.

Fibromyalgia have been reported to have neurodynamic disorders. The purpose of this prospective study was to examine the combined effects of soft tissue mobilization and nerve slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-03-29
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Study Start: 2014-01
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• 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
• Female sex.

Exclusion Criteria

• Male sex.
• Auditive and visual disturbances.
• Cognitive problems.
• Psychiatric pathology.
• Traumatic pathology of the hand.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo group	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.
Neurodynamic technique group	Neurodynamic technique group	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.

Primary Outcome Measures

Name	Time	Method
Nervous assessment	baseline, 8 weeks	Changes from baseline to postintervention measured with neurodynamic tests This is to test upper extremities. It moves most of the nerves between the neck and hand, including the median nerve, radial and ulnar, brachial plexus, spinal nerves and cervical nerve roots.; The patient is placed supine position. It is measured with a goniometer.

Secondary Outcome Measures

Name	Time	Method
Grip strength	baseline, 8 weeks	Changes from baseline to postintervention in grip strength. This is measured using a Jamar dynamometer with a standard protocol allowing three attempts on each side. During each measurement, patients were sitting with their shoulder adducted and elbow flexed to 90°. The maximum value achieved from all six attempts was used in analyses.; Kg/cm2
Manual dexterity	baseline, 8 weeks	Changes from baseline to postintervention in dexterity. This is assessed using the Purdue Pegboard Test.; The Purdue pegboard test is a timed physical test used to measure manual dexterity. Test subjects are asked to place small pins into holes in the pegboard using a specific hand and following a specific process.
Pressure pain measure	baseline, 8 weeks	Changes in pain pressure threshold from baseline to 8-weeks intervention. This is going to be measured in three points in upper extremities using the pressure algometer. All assessments were made by the same investigator. All the subjects were trained to familiarize the subjects with the pressure algometry procedure before the measures in an anatomical site different from the chosen sites for this study.

Trial Locations

Locations (1)

Faculty of Health Sciences. University of Granada.; 🇪🇸 Granada., Granada, Spain