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Completed

NCT Number: NCT02393352

Benefits of Dry Needling in Trigger Points on Autonomic Nervous System and Corporal 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Trigger Points

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adelaida María Castro-Sánchez

Almería, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dry Needling Therapy

Other

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.

Electrical Stimulation Therapy

Other

Primary outcomes

  1. Changes Scores on Visual Analoge Scale

    Time frame: At baseline and 4 weeks

    Intensity of pain (within McGill questionnaire)

Secondary outcomes

  1. 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.

  2. 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.

  3. Changes Scores on Cholinergic response indicators (%).

    Time frame: At baseline and 4 weeks

  4. Changes Scores on Heart rate variability.

    Time frame: At baseline and 4 weeks

  5. Changes Scores on Valsalva ratio. K30/15.

    Time frame: At baseline and 4 weeks

  6. Changes Scores on Systemic vascular resistance.

    Time frame: At baseline and 4 weeks

  7. Changes Scores on Systolic pressure.

    Time frame: At baseline and 4 weeks

  8. Changes Scores on Diastolic pressure.

    Time frame: At baseline and 4 weeks

  9. Changes Scores on Assessment of autonomic nervous system

    Time frame: At baseline and 4 weeks

    Galvanic response estimate.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 19, 2015
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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