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Completed

NCT Number: NCT01826695

Neurodynamic Intervention in Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences. University of Granada.

Granada, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurodynamic technique group

Other

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.

Other names: Neurodynamic sliding technique, Nerve mobilization

Placebo Group

Other

Women in this group realized standard treatment in the Fibromyalgia Association without neurodynamic techniques.

Other names: Standard treatment.

Primary outcomes

  1. Nervous assessment

    Time frame: 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 outcomes

  1. Manual dexterity

    Time frame: 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.

  2. Grip strength

    Time frame: 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

  3. Pressure pain measure

    Time frame: 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.

Other outcomes

  1. Anxiety and depression

    Time frame: baseline, 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Acronym: FM

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2013
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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