Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation

NCT ID: NCT03539588

Last Updated: 2018-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-12
• Study Completion Date: 2017-11-13

Brief Summary

trigger point dry needling with intramuscular electrical stimulation vs trigger point dry needling

Detailed Description

The purpose of this study is to evaluate if trigger point dry needling with intramuscular electrical stimulation is more effective in decreasing pain and disability in individuals with sub-acute and chronic low back pain (LBP) than with trigger point dry needling alone. The investigators are using a within subjects randomized crossover study that will recruit 30 active duty military personnel or beneficiaries from William Beaumont Army Medical Center and all associated clinics. The investigators hypothesize that individuals with LBP will exhibit larger improvements in pain and disability when receiving trigger point dry needling with intramuscular electrical stimulation than when receiving trigger point dry needling alone.

Conditions

Sub-acute and Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group 1

In this group participants will receive trigger point dry needling with electrical stimulation first and receive trigger point needling by itself second. Only MYOTECH dry needles will be used in this study. However we are not studying the equipment.

Group Type: ACTIVE_COMPARATOR

trigger point dry needling

Intervention Type: DEVICE

placement of the dry needle into the muscle tissue to elicit a local twitch response. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Electrical Stimulation

Intervention Type: DEVICE

uses the dry needles as nodes to stimulate muscular contraction. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Treatment Group 2

In this group the participants will receive trigger point dry needling first and receive trigger point dry needling with electrical stimulation second. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Group Type: ACTIVE_COMPARATOR

trigger point dry needling

Intervention Type: DEVICE

placement of the dry needle into the muscle tissue to elicit a local twitch response. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Electrical Stimulation

Intervention Type: DEVICE

uses the dry needles as nodes to stimulate muscular contraction. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Interventions

trigger point dry needling

placement of the dry needle into the muscle tissue to elicit a local twitch response. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Intervention Type: DEVICE

Electrical Stimulation

uses the dry needles as nodes to stimulate muscular contraction. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Currently experience low back pain for greater than 4 weeks (Low back pain defined as pain below the T12th vertebrae with or without radiation) Military or DOD Beneficiary (any branch; 18-65 years of age)

Exclusion Criteria

• Structural Deformity (ankylosing Spondylitis, Scoliosis)
• Has any other Orthopedic condition that may keep subject from performing Low - Back Exercises
• Tumors
• Spinal infection or local infection
• Pregnancy-All female subjects will be given either a blood serum or urine pregnancy test.
• Spinal cord compression or Cauda Equina Syndrome
• Subject with the inability to keep appointments
• Has History of prior surgery
• Has received Dry Needling or Acupuncture in the last 6 months
• History of bleeding disorders
• High anti-coagulant use
• History of immune suppression

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David K Hulsizer, DPT

Role: PRINCIPAL_INVESTIGATOR

WBAMC

Locations

William BAMC

El Paso, Texas, United States

Countries

United States

References

Armed Forces Health Surveillance Center-AFHSC. Absolute and relative morbidity burdens attributable to various illnesses and injuries, U.S. Armed Forces, 2011. MSMR. 2012 Apr;19(4):4-8; discussion 8-9. No abstract available.

Reference Type: BACKGROUND

PMID: 22587833 (View on PubMed)

April 2012 - v19_n04 - v19_n04.pdf." Accessed May 18, 2016. https://www.afhsc.mil/documents/pubs/msmrs/2012/v19_n04.pdf#Page=2.

Reference Type: BACKGROUND

Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Walther HU, Melchart D, Willich SN. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006 Feb 27;166(4):450-7. doi: 10.1001/archinte.166.4.450.

Reference Type: BACKGROUND

PMID: 16505266 (View on PubMed)

Cagnie B, Dewitte V, Barbe T, Timmermans F, Delrue N, Meeus M. Physiologic effects of dry needling. Curr Pain Headache Rep. 2013 Aug;17(8):348. doi: 10.1007/s11916-013-0348-5.

Reference Type: BACKGROUND

PMID: 23801002 (View on PubMed)

Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.

Reference Type: BACKGROUND

PMID: 19433697 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15928561 (View on PubMed)

Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.

Reference Type: BACKGROUND

PMID: 17909209 (View on PubMed)

Cohen SP, Brown C, Kurihara C, Plunkett A, Nguyen C, Strassels SA. Diagnoses and factors associated with medical evacuation and return to duty among nonmilitary personnel participating in military operations in Iraq and Afghanistan. CMAJ. 2011 Mar 22;183(5):E289-95. doi: 10.1503/cmaj.100244. Epub 2011 Feb 14.

Reference Type: BACKGROUND

PMID: 21324873 (View on PubMed)

Cohen SP, Griffith S, Larkin TM, Villena F, Larkin R. Presentation, diagnoses, mechanisms of injury, and treatment of soldiers injured in Operation Iraqi Freedom: an epidemiological study conducted at two military pain management centers. Anesth Analg. 2005 Oct;101(4):1098-1103. doi: 10.1213/01.ane.0000169332.45209.cf.

Reference Type: BACKGROUND

PMID: 16192528 (View on PubMed)

Cummings TM, White AR. Needling therapies in the management of myofascial trigger point pain: a systematic review. Arch Phys Med Rehabil. 2001 Jul;82(7):986-92. doi: 10.1053/apmr.2001.24023.

Reference Type: BACKGROUND

PMID: 11441390 (View on PubMed)

Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2724-7. doi: 10.1097/01.brs.0000244618.06877.cd.

Reference Type: BACKGROUND

PMID: 17077742 (View on PubMed)

Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102.

Reference Type: BACKGROUND

PMID: 19124635 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25143704 (View on PubMed)

Eisenberg DM, Post DE, Davis RB, Connelly MT, Legedza AT, Hrbek AL, Prosser LA, Buring JE, Inui TS, Cherkin DC. Addition of choice of complementary therapies to usual care for acute low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2007 Jan 15;32(2):151-8. doi: 10.1097/01.brs.0000252697.07214.65.

Reference Type: BACKGROUND

PMID: 17224808 (View on PubMed)

Ernat J, Knox J, Orchowski J, Owens B. Incidence and risk factors for acute low back pain in active duty infantry. Mil Med. 2012 Nov;177(11):1348-51. doi: 10.7205/milmed-d-12-00183.

Reference Type: BACKGROUND

PMID: 23198512 (View on PubMed)

Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

Reference Type: BACKGROUND

PMID: 11690728 (View on PubMed)

Fritz JM, George SZ. Identifying psychosocial variables in patients with acute work-related low back pain: the importance of fear-avoidance beliefs. Phys Ther. 2002 Oct;82(10):973-83.

Reference Type: BACKGROUND

PMID: 12350212 (View on PubMed)

Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther. 2001 Feb;81(2):776-88. doi: 10.1093/ptj/81.2.776.

Reference Type: BACKGROUND

PMID: 11175676 (View on PubMed)

Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005 Apr 15;30(8):944-63. doi: 10.1097/01.brs.0000158941.21571.01.

Reference Type: BACKGROUND

PMID: 15834340 (View on PubMed)

George SZ, Childs JD, Teyhen DS, Wu SS, Wright AC, Dugan JL, Robinson ME. Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009). BMC Musculoskelet Disord. 2007 Sep 14;8:92. doi: 10.1186/1471-2474-8-92.

Reference Type: BACKGROUND

PMID: 17868436 (View on PubMed)

Gilbert FJ, Grant AM, Gillan MG, Vale LD, Campbell MK, Scott NW, Knight DJ, Wardlaw D; Scottish Back Trial Group. Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial. Radiology. 2004 May;231(2):343-51. doi: 10.1148/radiol.2312030886. Epub 2004 Mar 18.

Reference Type: BACKGROUND

PMID: 15031430 (View on PubMed)

Giles LG, Muller R. Chronic spinal pain: a randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1490-502; discussion 1502-3. doi: 10.1097/00007632-200307150-00003.

Reference Type: BACKGROUND

PMID: 12865832 (View on PubMed)

Gunn CC, Milbrandt WE, Little AS, Mason KE. Dry needling of muscle motor points for chronic low-back pain: a randomized clinical trial with long-term follow-up. Spine (Phila Pa 1976). 1980 May-Jun;5(3):279-91. doi: 10.1097/00007632-198005000-00011. No abstract available.

Reference Type: BACKGROUND

PMID: 6446774 (View on PubMed)

Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C, Endres HG, Trampisch HJ, Molsberger A. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007 Sep 24;167(17):1892-8. doi: 10.1001/archinte.167.17.1892.

Reference Type: BACKGROUND

PMID: 17893311 (View on PubMed)

Hart LG, Deyo RA, Cherkin DC. Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine (Phila Pa 1976). 1995 Jan 1;20(1):11-9. doi: 10.1097/00007632-199501000-00003.

Reference Type: BACKGROUND

PMID: 7709270 (View on PubMed)

Hebert JJ, Koppenhaver SL, Walker BF. Subgrouping patients with low back pain: a treatment-based approach to classification. Sports Health. 2011 Nov;3(6):534-42. doi: 10.1177/1941738111415044.

Reference Type: BACKGROUND

PMID: 23016055 (View on PubMed)

Heliovaara M, Sievers K, Impivaara O, Maatela J, Knekt P, Makela M, Aromaa A. Descriptive epidemiology and public health aspects of low back pain. Ann Med. 1989 Oct;21(5):327-33. doi: 10.3109/07853898909149216.

Reference Type: BACKGROUND

PMID: 2532521 (View on PubMed)

Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.

Reference Type: BACKGROUND

PMID: 8043247 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9685106 (View on PubMed)

Hsieh YL, Kao MJ, Kuan TS, Chen SM, Chen JT, Hong CZ. Dry needling to a key myofascial trigger point may reduce the irritability of satellite MTrPs. Am J Phys Med Rehabil. 2007 May;86(5):397-403. doi: 10.1097/PHM.0b013e31804a554d.

Reference Type: BACKGROUND

PMID: 17449984 (View on PubMed)

Inoue M, Kitakoji H, Ishizaki N, Tawa M, Yano T, Katsumi Y, Kawakita K. Relief of low back pain immediately after acupuncture treatment--a randomised, placebo controlled trial. Acupunct Med. 2006 Sep;24(3):103-8. doi: 10.1136/aim.24.3.103.

Reference Type: BACKGROUND

PMID: 17013356 (View on PubMed)

Jarvik JG, Deyo RA. Diagnostic evaluation of low back pain with emphasis on imaging. Ann Intern Med. 2002 Oct 1;137(7):586-97. doi: 10.7326/0003-4819-137-7-200210010-00010.

Reference Type: BACKGROUND

PMID: 12353946 (View on PubMed)

Johnston BC, da Costa BR, Devereaux PJ, Akl EA, Busse JW; Expertise-Based RCT Working Group. The use of expertise-based randomized controlled trials to assess spinal manipulation and acupuncture for low back pain: a systematic review. Spine (Phila Pa 1976). 2008 Apr 15;33(8):914-8. doi: 10.1097/BRS.0b013e31816b4be4.

Reference Type: BACKGROUND

PMID: 18404113 (View on PubMed)

Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.

Reference Type: BACKGROUND

PMID: 20823359 (View on PubMed)

Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.

Reference Type: BACKGROUND

PMID: 16595438 (View on PubMed)

Konitzer LN, Fargo MV, Brininger TL, Lim Reed M. Association between back, neck, and upper extremity musculoskeletal pain and the individual body armor. J Hand Ther. 2008 Apr-Jun;21(2):143-8; quiz 149. doi: 10.1197/j.jht.2007.10.017.

Reference Type: BACKGROUND

PMID: 18436136 (View on PubMed)

Larsson R, Oberg AP, Larsson SE. Changes of trapezius muscle blood flow and electromyography in chronic neck pain due to trapezius myalgia. Pain. 1999 Jan;79(1):45-50. doi: 10.1016/S0304-3959(98)00144-4.

Reference Type: BACKGROUND

PMID: 9928775 (View on PubMed)

Lee SH, Chen CC, Lee CS, Lin TC, Chan RC. Effects of needle electrical intramuscular stimulation on shoulder and cervical myofascial pain syndrome and microcirculation. J Chin Med Assoc. 2008 Apr;71(4):200-6. doi: 10.1016/S1726-4901(08)70104-7.

Reference Type: BACKGROUND

PMID: 18436503 (View on PubMed)

Lewit K. The needle effect in the relief of myofascial pain. Pain. 1979 Feb;6(1):83-90. doi: 10.1016/0304-3959(79)90142-8.

Reference Type: BACKGROUND

PMID: 424236 (View on PubMed)

Lincoln AE, Smith GS, Amoroso PJ, Bell NS. The natural history and risk factors of musculoskeletal conditions resulting in disability among US Army personnel. Work. 2002;18(2):99-113.

Reference Type: BACKGROUND

PMID: 12441574 (View on PubMed)

Lucas N, Macaskill P, Irwig L, Moran R, Bogduk N. Reliability of physical examination for diagnosis of myofascial trigger points: a systematic review of the literature. Clin J Pain. 2009 Jan;25(1):80-9. doi: 10.1097/AJP.0b013e31817e13b6.

Reference Type: BACKGROUND

PMID: 19158550 (View on PubMed)

Lurie JD, Birkmeyer NJ, Weinstein JN. Rates of advanced spinal imaging and spine surgery. Spine (Phila Pa 1976). 2003 Mar 15;28(6):616-20. doi: 10.1097/01.BRS.0000049927.37696.DC.

Reference Type: BACKGROUND

PMID: 12642771 (View on PubMed)

Manheimer E, White A, Berman B, Forys K, Ernst E. Meta-analysis: acupuncture for low back pain. Ann Intern Med. 2005 Apr 19;142(8):651-63. doi: 10.7326/0003-4819-142-8-200504190-00014.

Reference Type: BACKGROUND

PMID: 15838072 (View on PubMed)

Molsberger AF, Mau J, Pawelec DB, Winkler J. Does acupuncture improve the orthopedic management of chronic low back pain--a randomized, blinded, controlled trial with 3 months follow up. Pain. 2002 Oct;99(3):579-587. doi: 10.1016/S0304-3959(02)00269-5.

Reference Type: BACKGROUND

PMID: 12406534 (View on PubMed)

Napadow V, Makris N, Liu J, Kettner NW, Kwong KK, Hui KK. Effects of electroacupuncture versus manual acupuncture on the human brain as measured by fMRI. Hum Brain Mapp. 2005 Mar;24(3):193-205. doi: 10.1002/hbm.20081.

Reference Type: BACKGROUND

PMID: 15499576 (View on PubMed)

Rainey CE. The use of trigger point dry needling and intramuscular electrical stimulation for a subject with chronic low back pain: a case report. Int J Sports Phys Ther. 2013 Apr;8(2):145-61.

Reference Type: BACKGROUND

PMID: 23593553 (View on PubMed)

Tough, Elizabeth A., and Adrian R. White. "Effectiveness of Acupuncture/dry Needling for Myofascial Trigger Point Pain." Physical Therapy Reviews 16, no. 2 (2011): 147-54.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18395479 (View on PubMed)

Vas J, Aranda JM, Modesto M, Benitez-Parejo N, Herrera A, Martinez-Barquin DM, Aguilar I, Sanchez-Araujo M, Rivas-Ruiz F. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial. Pain. 2012 Sep;153(9):1883-1889. doi: 10.1016/j.pain.2012.05.033. Epub 2012 Jul 4.

Reference Type: BACKGROUND

PMID: 22770838 (View on PubMed)

Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

Reference Type: BACKGROUND

PMID: 8455963 (View on PubMed)

Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.

Reference Type: BACKGROUND

PMID: 19420954 (View on PubMed)

Yeung CK, Leung MC, Chow DH. The use of electro-acupuncture in conjunction with exercise for the treatment of chronic low-back pain. J Altern Complement Med. 2003 Aug;9(4):479-90. doi: 10.1089/107555303322284767.

Reference Type: BACKGROUND

PMID: 14499023 (View on PubMed)

Other Identifiers

16-26

Identifier Type: -

Identifier Source: org_study_id