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Dry Needling and Functional Improvement (DN)

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ClinicalTrials.gov Identifier: NCT02838394
Recruitment Status : Unknown
Verified January 2018 by Brigham Young University.
Recruitment status was:  Recruiting
First Posted : July 20, 2016
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
Brigham Young University

Brief Summary:

Dry Needling (DN) is a skilled intervention that uses acupuncture filiform needles that are inserted into myofascial trigger points or other tissues underneath the skin. It is used to treat myofascial or neuromusculoskeletal pain and to improve movement impairments. Although more and more physical therapists add this treatment tool to their skill box, there is uncertainty about its working mechanism and its efficacy. The latter is partially due to the challenging task of finding and using a true control or sham treatment. The investigators will use blunted needles, which will not perforate the skin, as sham treatment.

This study will assess if DN of a trigger point in the gluteal muscles increases pain pressure threshold in that muscle, in another muscle innervated by the same segment (L4/5) and in an area not supplied by the same segment (i.e. the ipsilateral posterior shoulder). In addition, this study will assess if functionality, as measured by the Oswestry Disability Index (ODI) and 15-point Global Rating of Change Scale (GRoC) questionnaires, improves after 2-3 treatments (1 week) of DN.

Condition or disease Intervention/treatment Phase
Myofascial Trigger Point Pain Myofascial Pain Syndrome Procedure: Dry needling Other: Sham dry needling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does Site-specific Trigger Point Dry Needling Evoke Segmental Neuromodulation in the Lower Extremity and if so, do These Changes Make an Impact on the Subject's Disability?
Study Start Date : December 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dry Needling
Trigger points found in the gluteal region of one side (e.g. right) will be dry needled; presence of muscle twitching (which would signify appropriate needle insertion) will be documented.
Procedure: Dry needling
Acupuncture filiform needles are inserted into myofascial trigger points
Other Name: Trigger point dry needling, intramuscular needling

Sham Comparator: Sham Dry Needling
Trigger points found in the gluteal region of one side (e.g. right) will be SHAM dry needled with blunted needles, no actual penetration through the skin will occur.
Other: Sham dry needling
Blunted needles will be pressed against the skin, but no actual penetration will occur

Primary Outcome Measures :
  1. pressure sensitivity (pain pressure threshold) [ Time Frame: 1 week ]
    Pain pressure threshold values as measured with algometer

Secondary Outcome Measures :
  1. Low back pain as measured with visual analog scale (VAS) [ Time Frame: 1 week ]
    a 100 mm line with anchors on the left ('no pain') and on the right ('worst pain imaginable')

  2. modified Oswestry Disability Questionnaire (mOSW) [ Time Frame: 1 week ]
    A 10-item questionnaire assessing low back pain-related disability

  3. 15-point Global Rating of Change Scale (GRoC) [ Time Frame: 1 week ]
    A single item questionnaire, where the patient has to quantify his/her improvement or deterioration over time by choosing one of 15 possible answers.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • presence of at least one painful trigger point in the gluteals (gluteus maximus or medius) and infraspinatus on the same side.

Exclusion Criteria:

  • neurologic conditions (neuropathy, myopathy)
  • use of medication (antidepressants, opioids) and/or acute cervico-thoracic injury (whiplash, facet irritation, acute discopathy) that could directly influence normal somatosensory processing at the C5 segment [Srbely]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838394

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Contact: Ulrike Mitchell, PT, PhD 801 422 3344 Rike_mitchell@byu.edu
Contact: Patrick Cook, DPT 225 769 6161 pcook@peakphysicaltherapy.com

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United States, Louisiana
Peak Performance Physical Therapy, 7069 Perkins Rd Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Patrick Cook, PT    225-769-6161    pcook@peakphysicaltherapy.com   
United States, Utah
RPT-South Bangerter Recruiting
Riverton, Utah, United States, 84065
Contact: Brad Pulsipher, DPT, PT    801-302-8866    brad@rptutah.com   
Sponsors and Collaborators
Brigham Young University
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Principal Investigator: Ulrike H Mitchell, PT, PhD Brigham Young University
Publications of Results:

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Responsible Party: Brigham Young University
ClinicalTrials.gov Identifier: NCT02838394    
Other Study ID Numbers: 16225
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared with any other researcher
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases