Clinical trial NCT02393352: Benefits of Dry Needling in Trigger Points on Autonomic Nervous System and Corporal Composition in Patients With Fibromyalgia Syndrome
Official title: Benefits of Dry Needling in Trigger Points on Autonomic Nervous System, Photoelectric Plethysmography, Body Composition in Patients With Fibromyalgia Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Trigger Points
Keywords: Body Composition
Autonomic Nervous System
Oxygen
Randomized Controlled Trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the benefits of dry needling in trigger points on autonomic nervous system, photoelectric plethysmography, body composition in patients with fibromyalgia syndrome.

Detailed description: Dru needling can be developed on active trigger points. Myofascial trigger points can be active or latent. An active myofascial trigger point pain causes giving a specific pathological picture. We will conduct a location of myofascial trigger points following the illustrations location myofascial trigger points that indicate Travell and Simons both left-sided and right.

Eligibility criteria: Inclusion Criteria:

* Fibromyalgia syndrome diagnosis.
* Aged from 18 to 65 years.
* No regular physical activity.
* Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
* Agreement to attend evening therapy sessions.

Exclusion Criteria:

* Severe physical disability.
* Comorbid conditions (eg, morbid obesity, inflammatory diseases, irritable bowel syndrome, interstitial cystitis).
* Uncontrolled endocrine disorders (eg, hyperthyroidism or hypothyroidism, diabetes).
* Malignancy.
* Psychiatric.
* Illnesses (eg, schizophrenia or substance abuse).
* Medication usage other than as-needed analgesics (excluding long-term narcotics).
* History of surgery.
* History of whiplash injury.
* Presence of a score \>9 points in the Beck Depression Inventory.

Primary outcomes:
measure: Changes Scores on Visual Analoge Scale
timeFrame: At baseline and 4 weeks
Secondary outcomes:
measure: Changes Scores on Percentage Evaluation Peripheral Capillary Oxygen saturation and photoelectric plethysmograph (Analysis of pulse wave and PANI)
timeFrame: At baseline and 4 weeks
measure: Change Scores on Body Composition
timeFrame: At baseline and 4 weeks
measure: Changes Scores on Cholinergic response indicators (%).
timeFrame: At baseline and 4 weeks
measure: Changes Scores on Heart rate variability.
timeFrame: At baseline and 4 weeks
measure: Changes Scores on Valsalva ratio. K30/15.
timeFrame: At baseline and 4 weeks
measure: Changes Scores on Systemic vascular resistance.
timeFrame: At baseline and 4 weeks
measure: Changes Scores on Systolic pressure.
timeFrame: At baseline and 4 weeks
measure: Changes Scores on Diastolic pressure.
timeFrame: At baseline and 4 weeks
measure: Changes Scores on Assessment of autonomic nervous system
timeFrame: At baseline and 4 weeks
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Adelaida María Castro-Sánchez
Study officials:
References:
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