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
  Purpose

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.


Condition Intervention
Fibromyalgia
Other: Neurodynamic technique group
Other: Placebo group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Study of the Effectiveness of a Neurodynamic Intervention in Women With Fibromyalgia.

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 70
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Placebo group
Women in this group realized standard treatment in the Fibromyalgia Association without neurodynamic techniques.
Other Name: Standard treatment.
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826695

Contacts
Contact: Marie Carmen Valenza, PhD 958 248035 cvalenza@ugr.es

Locations
Spain
Faculty of Health Sciences. University of Granada. Recruiting
Granada., Granada, Spain, 18071
Contact: Marie Carmen Valenza, PhD    958 248035    cvalenza@ugr.es   
Principal Investigator: Marie Carmen Valenza, PT, PhD         
Sponsors and Collaborators
Universidad de Granada
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, Assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01826695     History of Changes
Other Study ID Numbers: DF0040UG
Study First Received: March 29, 2013
Last Updated: May 17, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
Fibromyalgia, neurodynamic, dexterity

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014