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Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients With Fibromyalgia Syndrome.

Primary Purpose

Fibromyalgia, Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry Needling
Cross Tape 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 Paraspinal Muscles, Trigger Points, Randomized Controlled Trial, Mobility Limitation

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

  • Univesity of Almería

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling Therapy

Cross Tape Therapy

Arm Description

Dry Needly Therapy will be assesses in trigger points on latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle.

Cross Tape is a grid-shaped bandage easy aplicacionen different parts of the body that regulates the tension.

Outcomes

Primary Outcome Measures

Pain Intensity
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.

Secondary Outcome Measures

Number of participants with Trigger Points
Dry Needly Therapy will be assesses in trigger points on trapezius muscle, supraspinatus muscle, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle.
Posture and Spinal Mobility
Spinal Mouse is a device that, combined with a computer program (PC), assesses the curvatures of the vertebral column without applying harmful radiation. Spinal Mouse checks: spine alignment, measuring segmental and global angles in the sagittal and frontal planes; posture and spinal mobility; and spine functions and performance.

Full Information

First Posted
February 28, 2015
Last Updated
January 19, 2016
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT02380807
Brief Title
Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients With Fibromyalgia Syndrome.
Official Title
Effects of Dry Needling on Posture, Spinal Mobility and Trigger Points on Spinal Muscles in Patients With Fibromyalgia Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
July 2015 (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 effect of Dry Needling on Spinal Mobility and Trigger Points in Patients with Fibromyalgia Syndrome.
Detailed Description
Dry Needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments. Dry needling (DN) is a technique used to treat dysfunctions in skeletal muscle, fascia, and connective tissue, and, diminish persistent peripheral nociceptive input, and reduce or restore impairments of body structure and function leading to improved activity and participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Back Pain
Keywords
Paraspinal Muscles, Trigger Points, Randomized Controlled Trial, Mobility Limitation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dry Needling Therapy
Arm Type
Experimental
Arm Description
Dry Needly Therapy will be assesses in trigger points on latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle.
Arm Title
Cross Tape Therapy
Arm Type
Active Comparator
Arm Description
Cross Tape is a grid-shaped bandage easy aplicacionen different parts of the body that regulates the tension.
Intervention Type
Device
Intervention Name(s)
Dry Needling
Intervention Description
Dry needling is the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, sometimes also known as intramuscular stimulation (IMS). Although dry needling originally utilized only hypodermic needles due to the concern that solid filiform needles had neither the strength or tactile feedback that hypodermic needles provided and that the solid filiform needle could be deflected by "dense contraction knots".
Intervention Type
Other
Intervention Name(s)
Cross Tape Therapy
Intervention Description
The tape consists of cross bands or strips mesh cross, nonelastic and without any medication, forming a grid-shaped patch. The cross tape will be applied on trigger points.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
Time Frame
up to Four Weeks
Secondary Outcome Measure Information:
Title
Number of participants with Trigger Points
Description
Dry Needly Therapy will be assesses in trigger points on trapezius muscle, supraspinatus muscle, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourum muscle.
Time Frame
up to Four Weeks
Title
Posture and Spinal Mobility
Description
Spinal Mouse is a device that, combined with a computer program (PC), assesses the curvatures of the vertebral column without applying harmful radiation. Spinal Mouse checks: spine alignment, measuring segmental and global angles in the sagittal and frontal planes; posture and spinal mobility; and spine functions and performance.
Time Frame
up to Four 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
Univesity of Almería
City
Almería
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

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Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients With Fibromyalgia Syndrome.

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