Neurodynamic Intervention in Fibromyalgia (FM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01826695
First received: March 29, 2013
Last updated: May 17, 2014
Last verified: May 2014

March 29, 2013
May 17, 2014
January 2014
June 2014   (final data collection date for primary outcome measure)
Nervous assessment [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: Yes ]

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.

Same as current
Complete list of historical versions of study NCT01826695 on ClinicalTrials.gov Archive Site
  • Manual dexterity [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: Yes ]

    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.

  • Grip strength [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: Yes ]

    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

  • Pressure pain measure [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    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.
Same as current
Anxiety and depression [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: Yes ]
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.
Same as current
 
Neurodynamic Intervention in Fibromyalgia
Study of the Effectiveness of a Neurodynamic Intervention in Women With 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Fibromyalgia
  • 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.

    Other Names:
    • Neurodynamic sliding technique
    • Nerve mobilization
  • Other: Placebo group
    Women in this group realized standard treatment in the Fibromyalgia Association without neurodynamic techniques.
    Other Name: Standard treatment.
  • Placebo Comparator: 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.
    Intervention: Other: Placebo group
  • Active Comparator: 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.
    Intervention: Other: Neurodynamic technique group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2014
June 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Marie Carmen Valenza, PhD 958 248035 cvalenza@ugr.es
Spain
 
NCT01826695
DF0040UG
Yes
Marie Carmen Valenza, Universidad de Granada
Universidad de Granada
Not Provided
Not Provided
Universidad de Granada
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP