Neurodynamic Intervention in Fibromyalgia

Fibromyalgia Clinical Trial

— FM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826695
• Other study ID #: DF0040UG
• Status: Completed
• Phase: N/A
• First received: March 29, 2013
• Last updated: October 27, 2016
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Neurodynamic technique group
Neurodynamic techniques are used in order to move 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. The treatment will be carry out 3 times per week during 8 weeks.
• Placebo group
Women in this group realized standard treatment in the Fibromyalgia Association without neurodynamic techniques.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences. University of Granada.	Granada.	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Torres JR, Martos IC, Sánchez IT, Rubio AO, Pelegrina AD, Valenza MC. Results of an Active Neurodynamic Mobilization Program in Patients With Fibromyalgia Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Oct;96(10):1771-8. doi: 10.1016/j.apmr.2015.06.008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety and depression	Changes from baseline to postintervention in anxiety and depression in the participants. Participants completed the Hospital Anxiety and Depression Scale in order to assess these parameters.	baseline, 8 weeks	Yes
Primary	Nervous assessment	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.	baseline, 8 weeks	Yes
Secondary	Manual dexterity	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.	baseline, 8 weeks	Yes
Secondary	Grip strength	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	baseline, 8 weeks	Yes
Secondary	Pressure pain measure	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.	baseline, 8 weeks	Yes