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

Study Overview
=================
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.

Official Title
-----------------
Benefits of Dry Needling in Trigger Points on Autonomic Nervous System, Photoelectric Plethysmography, Body Composition in Patients With Fibromyalgia Syndrome.

Conditions
-----------------
Fibromyalgia, Trigger Points

Intervention / Treatment
-----------------
* Other: Dry Needling Therapy
* Other: Electrical Stimulation Therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Needling Therapy<br>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. | Other: Dry Needling Therapy<br>* 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.<br>|
| Active Comparator: Electrical Stimulation Therapy<br>Diadynamic fixed current phase in active trigger points, with pulses of 10msec, and intervals of equal duration. | Other: Electrical Stimulation Therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes Scores on Visual Analoge Scale | Intensity of pain (within McGill questionnaire) | At baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes Scores on Percentage Evaluation Peripheral Capillary Oxygen saturation and photoelectric plethysmograph (Analysis of pulse wave and PANI) | Cardiac output. Reflectivity index. Stiffness index. Oxygen saturation. | At baseline and 4 weeks | 
| Change Scores on Body Composition | Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water. | At baseline and 4 weeks | 
| Changes Scores on Cholinergic response indicators (%). |  | 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 Systemic vascular resistance. |  | 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 | 
| Changes Scores on Assessment of autonomic nervous system | Galvanic response estimate. | At baseline and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxygen, Body Composition, Autonomic Nervous System, Randomized Controlled Trial