Fibromyalgia Clinical Trial
— FMOfficial title:
Study of the Effectiveness of a Neurodynamic Intervention in Women With Fibromyalgia.
Verified date | October 2016 |
Source | Universidad de Granada |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Health Sciences. University of Granada. | Granada. | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
Torres JR, Martos IC, Sánchez 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Anxiety and depression | 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. | baseline, 8 weeks | Yes |
Primary | 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 | Yes |
Secondary | 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. |
baseline, 8 weeks | Yes |
Secondary | 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 |
baseline, 8 weeks | Yes |
Secondary | 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. | baseline, 8 weeks | Yes |
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