Benefits of Dry Needling in Trigger Points on Autonomic Nervous System and Corporal Composition in Patients With Fibromyalgia Syndrome

Not Applicable

Completed

• Conditions: Fibromyalgia; Trigger Points
• Interventions: Other: Electrical Stimulation Therapy; Other: Dry Needling Therapy

• Registration Number: NCT02393352
• Lead Sponsor: Universidad de Almeria

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.

Study Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Study Start: 2016-03
• Primary Completion: 2016-11
• Study Completion: 2017-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrical Stimulation Therapy	Electrical Stimulation Therapy	Diadynamic fixed current phase in active trigger points, with pulses of 10msec, and intervals of equal duration.
Dry Needling Therapy	Dry Needling Therapy	The dry needling therapy will be applied on active trigger points in occipital muscle, splenius capitis, sternocleidomastoid muscle, scalene muscles, trapezius, supraspinatus, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourm muscles.

Primary Outcome Measures

Name	Time	Method
Changes Scores on Visual Analoge Scale	At baseline and 4 weeks	Intensity of pain (within McGill questionnaire)

Secondary Outcome Measures

Name	Time	Method
Changes Scores on Percentage Evaluation Peripheral Capillary Oxygen saturation and photoelectric plethysmograph (Analysis of pulse wave and PANI)	At baseline and 4 weeks	Cardiac output. Reflectivity index. Stiffness index. Oxygen saturation.
Change Scores on Body Composition	At baseline and 4 weeks	Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.
Changes Scores on Systemic vascular resistance.	At baseline and 4 weeks
Changes Scores on Heart rate variability.	At baseline and 4 weeks
Changes Scores on Valsalva ratio. K30/15.	At baseline and 4 weeks
Changes Scores on Assessment of autonomic nervous system	At baseline and 4 weeks	Galvanic response estimate.
Changes Scores on Cholinergic response indicators (%).	At baseline and 4 weeks
Changes Scores on Systolic pressure.	At baseline and 4 weeks
Changes Scores on Diastolic pressure.	At baseline and 4 weeks

Trial Locations

Locations (1)

Adelaida María Castro-Sánchez; 🇪🇸 Almería, Spain