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
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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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- pressure sensitivity (pain pressure threshold) [ Time Frame: 1 week ]Pain pressure threshold values as measured with algometer
- 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')
- modified Oswestry Disability Questionnaire (mOSW) [ Time Frame: 1 week ]A 10-item questionnaire assessing low back pain-related disability
- 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|
- presence of at least one painful trigger point in the gluteals (gluteus maximus or medius) and infraspinatus on the same side.
- 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]
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
|Contact: Ulrike Mitchell, PT, PhD||801 422 3344||Rike_mitchell@byu.edu|
|Contact: Patrick Cook, DPT||225 769 email@example.com|
|United States, Louisiana|
|Peak Performance Physical Therapy, 7069 Perkins Rd||Recruiting|
|Baton Rouge, Louisiana, United States, 70808|
|Contact: Patrick Cook, PT 225-769-6161 firstname.lastname@example.org|
|United States, Utah|
|Riverton, Utah, United States, 84065|
|Contact: Brad Pulsipher, DPT, PT 801-302-8866 email@example.com|
|Principal Investigator:||Ulrike H Mitchell, PT, PhD||Brigham Young University|
|Responsible Party:||Brigham Young University|
|Other Study ID Numbers:||
|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|
Myofascial Pain Syndromes
Nervous System Diseases