NCT01826695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 29, 2013

Last Update Submit

October 27, 2016

Conditions

Fibromyalgia

Keywords

Fibromyalgia, neurodynamic, dexterity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Manual dexterity

    baseline, 8 weeks

  • Grip strength

    baseline, 8 weeks

  • Pressure pain measure

    baseline, 8 weeks

Other Outcomes (1)

  • Anxiety and depression

    baseline, 8 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Neurodynamic technique group

ACTIVE COMPARATOR

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

Interventions

Neurodynamic technique groupOTHER

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.

Also known as: Neurodynamic sliding technique, Nerve mobilization
Neurodynamic technique group
Placebo groupOTHER

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

Also known as: Standard treatment.
Placebo group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Male sex.
  • Auditive and visual disturbances.
  • Cognitive problems.
  • Psychiatric pathology.
  • Traumatic pathology of the hand.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26143052BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Marie Carmen Valenza, phD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 8, 2013

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

ES(1)