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Neurodynamic Intervention in Fibromyalgia (FM)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neurodynamic technique group
Placebo group
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, neurodynamic, dexterity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Health Sciences. University of Granada.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group

Neurodynamic technique group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
March 29, 2013
Last Updated
October 27, 2016
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT01826695
Brief Title
Neurodynamic Intervention in Fibromyalgia
Acronym
FM
Official Title
Study of the Effectiveness of a Neurodynamic Intervention in Women With Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, neurodynamic, dexterity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Neurodynamic technique group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Neurodynamic technique group
Other Intervention Name(s)
Neurodynamic sliding technique, Nerve mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo group
Other Intervention Name(s)
Standard treatment.
Intervention Description
Women in this group realized standard treatment in the Fibromyalgia Association without neurodynamic techniques.
Primary Outcome Measure Information:
Title
Nervous assessment
Description
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.
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Manual dexterity
Description
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.
Time Frame
baseline, 8 weeks
Title
Grip strength
Description
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
Time Frame
baseline, 8 weeks
Title
Pressure pain measure
Description
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.
Time Frame
baseline, 8 weeks
Other Pre-specified Outcome Measures:
Title
Anxiety and depression
Description
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.
Time Frame
baseline, 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, phD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada.
City
Granada.
State/Province
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26143052
Citation
Torres JR, Martos IC, Sanchez 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. Epub 2015 Jul 2.
Results Reference
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Neurodynamic Intervention in Fibromyalgia

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