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

October 30, 2017 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Adelaida María Castro-Sánchez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes Scores on Visual Analoge Scale
Time Frame: At baseline and 4 weeks
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)
Time Frame: At baseline and 4 weeks
Cardiac output. Reflectivity index. Stiffness index. Oxygen saturation.
At baseline and 4 weeks
Change Scores on Body Composition
Time Frame: At baseline and 4 weeks
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 (%).
Time Frame: At baseline and 4 weeks
At baseline and 4 weeks
Changes Scores on Heart rate variability.
Time Frame: At baseline and 4 weeks
At baseline and 4 weeks
Changes Scores on Valsalva ratio. K30/15.
Time Frame: At baseline and 4 weeks
At baseline and 4 weeks
Changes Scores on Systemic vascular resistance.
Time Frame: At baseline and 4 weeks
At baseline and 4 weeks
Changes Scores on Systolic pressure.
Time Frame: At baseline and 4 weeks
At baseline and 4 weeks
Changes Scores on Diastolic pressure.
Time Frame: At baseline and 4 weeks
At baseline and 4 weeks
Changes Scores on Assessment of autonomic nervous system
Time Frame: At baseline and 4 weeks
Galvanic response estimate.
At baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL_435

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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