NCT02838394

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 25, 2024

Status Verified

July 1, 2023

Enrollment Period

6.7 years

First QC Date

July 18, 2016

Last Update Submit

April 24, 2024

Conditions

Myofascial Trigger Point PainMyofascial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • pressure sensitivity (pain pressure threshold)

    Pain pressure threshold values as measured with algometer

    1 week

Secondary Outcomes (3)

  • Low back pain as measured with visual analog scale (VAS)

    1 week

  • modified Oswestry Disability Questionnaire (mOSW)

    1 week

  • 15-point Global Rating of Change Scale (GRoC)

    1 week

Study Arms (2)

Dry Needling

EXPERIMENTAL

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

Sham Dry Needling

SHAM COMPARATOR

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

Interventions

Dry needlingPROCEDURE

Acupuncture filiform needles are inserted into myofascial trigger points

Also known as: Trigger point dry needling, intramuscular needling
Dry Needling
Sham dry needlingOTHER

Blunted needles will be pressed against the skin, but no actual penetration will occur

Sham Dry Needling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 \[Srbely\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham Young University Athletics

Provo, Utah, 84602, United States

Location

Related Publications (18)

  • Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.

    PMID: 25143704RESULT

  • Bron C, Dommerholt JD. Etiology of myofascial trigger points. Curr Pain Headache Rep. 2012 Oct;16(5):439-44. doi: 10.1007/s11916-012-0289-4.

    PMID: 22836591RESULT

  • Hong CZ, Simons DG. Pathophysiologic and electrophysiologic mechanisms of myofascial trigger points. Arch Phys Med Rehabil. 1998 Jul;79(7):863-72. doi: 10.1016/s0003-9993(98)90371-9.

    PMID: 9685106RESULT

  • Shah JP, Gilliams EA. Uncovering the biochemical milieu of myofascial trigger points using in vivo microdialysis: an application of muscle pain concepts to myofascial pain syndrome. J Bodyw Mov Ther. 2008 Oct;12(4):371-384. doi: 10.1016/j.jbmt.2008.06.006. Epub 2008 Aug 13.

    PMID: 19083696RESULT

  • Quintner JL, Bove GM, Cohen ML. A critical evaluation of the trigger point phenomenon. Rheumatology (Oxford). 2015 Mar;54(3):392-9. doi: 10.1093/rheumatology/keu471. Epub 2014 Dec 3.

    PMID: 25477053RESULT

  • Quintner JL, Cohen ML. Referred pain of peripheral nerve origin: an alternative to the "myofascial pain" construct. Clin J Pain. 1994 Sep;10(3):243-51. doi: 10.1097/00002508-199409000-00012.

    PMID: 7833584RESULT

  • Fernandez-de-las-Penas C, Cuadrado ML, Arendt-Nielsen L, Simons DG, Pareja JA. Myofascial trigger points and sensitization: an updated pain model for tension-type headache. Cephalalgia. 2007 May;27(5):383-93. doi: 10.1111/j.1468-2982.2007.01295.x. Epub 2007 Mar 14.

    PMID: 17359516RESULT

  • Niddam DM, Chan RC, Lee SH, Yeh TC, Hsieh JC. Central representation of hyperalgesia from myofascial trigger point. Neuroimage. 2008 Feb 1;39(3):1299-306. doi: 10.1016/j.neuroimage.2007.09.051. Epub 2007 Oct 11.

    PMID: 17999939RESULT

  • Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. Eur J Pain. 2009 Jan;13(1):3-10. doi: 10.1016/j.ejpain.2008.02.006. Epub 2008 Apr 18.

    PMID: 18395479RESULT

  • Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.

    PMID: 23138883RESULT

  • Kietrys DM, Palombaro KM, Azzaretto E, Hubler R, Schaller B, Schlussel JM, Tucker M. Effectiveness of dry needling for upper-quarter myofascial pain: a systematic review and meta-analysis. J Orthop Sports Phys Ther. 2013 Sep;43(9):620-34. doi: 10.2519/jospt.2013.4668.

    PMID: 23756457RESULT

  • Boyles R, Fowler R, Ramsey D, Burrows E. Effectiveness of trigger point dry needling for multiple body regions: a systematic review. J Man Manip Ther. 2015 Dec;23(5):276-93. doi: 10.1179/2042618615Y.0000000014.

    PMID: 26955257RESULT

  • Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998 Aug 1;352(9125):364-5. doi: 10.1016/S0140-6736(97)10471-8.

    PMID: 9717924RESULT

  • Srbely JZ, Dickey JP, Lee D, Lowerison M. Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects. J Rehabil Med. 2010 May;42(5):463-8. doi: 10.2340/16501977-0535.

    PMID: 20544158RESULT

  • Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16.

    PMID: 18201937RESULT

  • Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

    PMID: 20046623RESULT

  • Chou LW, Hsieh YL, Kuan TS, Hong CZ. Needling therapy for myofascial pain: recommended technique with multiple rapid needle insertion. Biomedicine (Taipei). 2014;4(2):13. doi: 10.7603/s40681-014-0013-2. Epub 2014 Aug 2.

    PMID: 25520926RESULT

  • Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

    PMID: 15928561RESULT

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Ulrike H Mitchell, PT, PhD

    Brigham Young University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

December 1, 2016

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 25, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Data will not be shared with any other researcher

Locations

US(1)