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

Primary Purpose

Fibromyalgia, Trigger Points

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry Needling Therapy
Electrical Stimulation Therapy
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Body Composition, Autonomic Nervous System, Oxygen, Randomized Controlled Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Adelaida María Castro-Sánchez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling Therapy

Electrical Stimulation Therapy

Arm Description

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.

Diadynamic fixed current phase in active trigger points, with pulses of 10msec, and intervals of equal duration.

Outcomes

Primary Outcome Measures

Changes Scores on Visual Analoge Scale
Intensity of pain (within McGill questionnaire)

Secondary Outcome Measures

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.
Change Scores on Body Composition
Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.
Changes Scores on Cholinergic response indicators (%).
Changes Scores on Heart rate variability.
Changes Scores on Valsalva ratio. K30/15.
Changes Scores on Systemic vascular resistance.
Changes Scores on Systolic pressure.
Changes Scores on Diastolic pressure.
Changes Scores on Assessment of autonomic nervous system
Galvanic response estimate.

Full Information

First Posted
March 4, 2015
Last Updated
October 30, 2017
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT02393352
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Trigger Points
Keywords
Body Composition, Autonomic Nervous System, Oxygen, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Electrical Stimulation Therapy
Arm Type
Active Comparator
Arm Description
Diadynamic fixed current phase in active trigger points, with pulses of 10msec, and intervals of equal duration.
Intervention Type
Other
Intervention Name(s)
Dry Needling Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Electrical Stimulation Therapy
Primary Outcome Measure Information:
Title
Changes Scores on Visual Analoge Scale
Description
Intensity of pain (within McGill questionnaire)
Time Frame
At baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Changes Scores on Percentage Evaluation Peripheral Capillary Oxygen saturation and photoelectric plethysmograph (Analysis of pulse wave and PANI)
Description
Cardiac output. Reflectivity index. Stiffness index. Oxygen saturation.
Time Frame
At baseline and 4 weeks
Title
Change Scores on Body Composition
Description
Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.
Time Frame
At baseline and 4 weeks
Title
Changes Scores on Cholinergic response indicators (%).
Time Frame
At baseline and 4 weeks
Title
Changes Scores on Heart rate variability.
Time Frame
At baseline and 4 weeks
Title
Changes Scores on Valsalva ratio. K30/15.
Time Frame
At baseline and 4 weeks
Title
Changes Scores on Systemic vascular resistance.
Time Frame
At baseline and 4 weeks
Title
Changes Scores on Systolic pressure.
Time Frame
At baseline and 4 weeks
Title
Changes Scores on Diastolic pressure.
Time Frame
At baseline and 4 weeks
Title
Changes Scores on Assessment of autonomic nervous system
Description
Galvanic response estimate.
Time Frame
At baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Adelaida María Castro-Sánchez
City
Almería
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20461783
Citation
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Results Reference
derived

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

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