Trial record 51 of 116 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Universidad de Almeria
Sponsor:
Information provided by (Responsible Party):
Adelaida María Castro-Sánchez, Universidad de Almeria
ClinicalTrials.gov Identifier:
NCT02380807
First received: February 28, 2015
Last updated: March 9, 2015
Last verified: March 2015
  Purpose

This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in Patients with Fibromyalgia Syndrome.


Condition Intervention
Fibromyalgia
Back Pain
Device: Dry Needling
Other: Cross Tape Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Dry Needling on Posture, Spinal Mobility and Trigger Points on Spinal Muscles in Patients With Fibromyalgia Syndrome.

Resource links provided by NLM:


Further study details as provided by Universidad de Almeria:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: up to Four Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to Four Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to Four Weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 66
Study Start Date: March 2015
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dry Needling Therapy
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.
Device: Dry Needling
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".
Active Comparator: Cross Tape Therapy
Cross Tape is a grid-shaped bandage easy aplicacionen different parts of the body that regulates the tension.
Other: Cross Tape Therapy
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02380807

Contacts
Contact: Adelaida María Castro-Sánchez, PhD. Lecturer +34689723203 adelaid@ual.es

Locations
Spain
Univesity of Almería Recruiting
Almería, Spain, 04120
Contact: Adelaida María Castro-Sánchez, PhD    +34950214576    adelaid@ual.es   
Sponsors and Collaborators
Universidad de Almeria
  More Information

Publications:

Responsible Party: Adelaida María Castro-Sánchez, PhD (Lecturer), Universidad de Almeria
ClinicalTrials.gov Identifier: NCT02380807     History of Changes
Other Study ID Numbers: UAL- 423
Study First Received: February 28, 2015
Last Updated: March 9, 2015
Health Authority: Spain: Ethics Committee

Keywords provided by Universidad de Almeria:
Paraspinal Muscles
Trigger Points
Randomized Controlled Trial
Mobility Limitation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on March 25, 2015