Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling
NCT ID: NCT04170803
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
18 participants
INTERVENTIONAL
2019-01-08
2020-07-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dry Needling and Shoulder Muscle Blood Flow, Motions, and Pain Sensitivity in Individuals with Shoulder Pain
NCT05596240
Dry Needling and Shoulder Muscle Blood Flow, Motions, and Pain Sensitivity
NCT05467098
Dry Needling in Subjects With Delayed Onset Muscle Soreness
NCT03876080
Effects of Dry Needling When Applied to the Infraspinatus Muscle in People With Chronic Shoulder Pain
NCT04316793
Hamstring Tightness
NCT02516137
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Specific Aim #1: The investigators will compare the cortical pain pathway response during dry needling treatment to sham dry needling treatment using NIRS in two groups of patients with chronic shoulder pain.
The investigators hypothesize that decreased cortical activity will be seen in the dorsolateral prefrontal cortex (DLPFC) in those treated with true dry needling compared to those treated with sham dry needling.
Specific Aim #2: The investigators will evaluate whether the cortical pain pathway response (imaged using NIRS) during dry needling predicts 1-week improvement in shoulder muscle response, local hypoalgesia, and self-reported pain and disability in the group of patients that received true dry needling treatment. The investigators hypothesize that decreased cortical activity in the DLPFC will be associated with improvements in shoulder muscle response, local hypoalgesia, and self-reported pain and disability in those treated with true dry needling.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
True Dry Needling
Active duty DoD beneficiaries, with shoulder pain will be recruited from Army Medical Department Center and School (AMEDDC\&S) and the Brooke Army Medical Center (BAMC) Outpatient Physical Therapy Clinic who meet inclusion and exclusion criteria. The TDN treatment will consist of a trained investigator inserting a needle through the participant's skin, into the infraspinatus muscle using FDA approved (FDA regulation # 880.5580) disposable 0.25 x 40 mm stainless steel Seirin J-type needles (Seirin, Japan). Each shoulder will undergo this treatment. Each needle insertion will last approximately 2-3 seconds using the "sparrow pecking" (in and out) technique to the depth of the scapula at 3 locations in the infraspinatus muscle on the affected (painful) side. When detectable, the needle insertion will specifically target palpably painful and/or "taut" bands of tissue. Immediately after use, all needles will be disposed of in approved sharps containers.
Dry Needling
The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.
Sham Dry Needling
The sham dry-needling procedure will mimic the dry needling procedures by placing a blunted instrument in a needling guide tube against the skin. The sharp object will be rocked and twisted to simulate treatment, but will not pierce the skin. We have used this sham dry-needling technique in previous studies performed at AMEDDC\&S and have found it to be indistinguishable from real dry needling by the great majority of participants..
Sham Dry Needling
The participant randomized to the "sham" group will undergo placebo dry needling which is functionally mimicking trigger point dry needling
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dry Needling
The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.
Sham Dry Needling
The participant randomized to the "sham" group will undergo placebo dry needling which is functionally mimicking trigger point dry needling
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brooke Army Medical Center
FED
Army-Baylor University Doctoral Program in Physical Therapy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Army Medical Department Center and Schools, Ft Sam Houston
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Koppenhaver SL, Walker MJ, Smith RW, Booker JM, Walkup ID, Su J, Hebert JJ, Flynn T. Baseline Examination Factors Associated With Clinical Improvement After Dry Needling in Individuals With Low Back Pain. J Orthop Sports Phys Ther. 2015 Aug;45(8):604-12. doi: 10.2519/jospt.2015.5801. Epub 2015 Jun 25.
Songer TJ, LaPorte RE. Disabilities due to injury in the military. Am J Prev Med. 2000 Apr;18(3 Suppl):33-40. doi: 10.1016/s0749-3797(00)00107-0.
Belmont PJ Jr, Goodman GP, Waterman B, DeZee K, Burks R, Owens BD. Disease and nonbattle injuries sustained by a U.S. Army Brigade Combat Team during Operation Iraqi Freedom. Mil Med. 2010 Jul;175(7):469-76. doi: 10.7205/milmed-d-10-00041.
Galanter M, Dermatis H, Sampson C. Narcotics anonymous: a comparison of military veterans and non-veterans. J Addict Dis. 2014;33(3):187-95. doi: 10.1080/10550887.2014.950031.
Vanderlip ER, Sullivan MD, Edlund MJ, Martin BC, Fortney J, Austen M, Williams JS, Hudson T. National study of discontinuation of long-term opioid therapy among veterans. Pain. 2014 Dec;155(12):2673-2679. doi: 10.1016/j.pain.2014.09.034. Epub 2014 Sep 30.
Mosher HJ, Krebs EE, Carrel M, Kaboli PJ, Weg MW, Lund BC. Trends in prevalent and incident opioid receipt: an observational study in Veterans Health Administration 2004-2012. J Gen Intern Med. 2015 May;30(5):597-604. doi: 10.1007/s11606-014-3143-z. Epub 2014 Dec 18.
Jonas WB, Schoomaker EB. Pain and opioids in the military: we must do better. JAMA Intern Med. 2014 Aug;174(8):1402-3. doi: 10.1001/jamainternmed.2014.2114. No abstract available.
Petri RP Jr. Integrative Health and Healing as the New Health Care Paradigm for the Military. Med Acupunct. 2015 Oct 1;27(5):301-308. doi: 10.1089/acu.2014.1068.
Thomas DA, Maslin B, Legler A, Springer E, Asgerally A, Vadivelu N. Role of Alternative Therapies for Chronic Pain Syndromes. Curr Pain Headache Rep. 2016 May;20(5):29. doi: 10.1007/s11916-016-0562-z.
Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. Natl Health Stat Report. 2015 Feb 10;(79):1-16.
Sherman KJ, Cherkin DC, Eisenberg DM, Erro J, Hrbek A, Deyo RA. The practice of acupuncture: who are the providers and what do they do? Ann Fam Med. 2005 Mar-Apr;3(2):151-8. doi: 10.1370/afm.248.
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.
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.
Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.
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.
Zhou K, Ma Y, Brogan MS. Dry needling versus acupuncture: the ongoing debate. Acupunct Med. 2015 Dec;33(6):485-90. doi: 10.1136/acupmed-2015-010911. Epub 2015 Nov 6.
Vulfsons S, Ratmansky M, Kalichman L. Trigger point needling: techniques and outcome. Curr Pain Headache Rep. 2012 Oct;16(5):407-12. doi: 10.1007/s11916-012-0279-6.
Hsieh YL, Chou LW, Joe YS, Hong CZ. Spinal cord mechanism involving the remote effects of dry needling on the irritability of myofascial trigger spots in rabbit skeletal muscle. Arch Phys Med Rehabil. 2011 Jul;92(7):1098-105. doi: 10.1016/j.apmr.2010.11.018. Epub 2011 May 6.
Koppenhaver SL, Walker MJ, Su J, McGowen JM, Umlauf L, Harris KD, Ross MD. Changes in lumbar multifidus muscle function and nociceptive sensitivity in low back pain patient responders versus non-responders after dry needling treatment. Man Ther. 2015 Dec;20(6):769-76. doi: 10.1016/j.math.2015.03.003. Epub 2015 Mar 13.
Cagnie B, Barbe T, De Ridder E, Van Oosterwijck J, Cools A, Danneels L. The influence of dry needling of the trapezius muscle on muscle blood flow and oxygenation. J Manipulative Physiol Ther. 2012 Nov-Dec;35(9):685-91. doi: 10.1016/j.jmpt.2012.10.005.
Aird L, Samuel D, Stokes M. Quadriceps muscle tone, elasticity and stiffness in older males: reliability and symmetry using the MyotonPRO. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):e31-9. doi: 10.1016/j.archger.2012.03.005. Epub 2012 Apr 13.
Ylinen J. Pressure algometry. Aust J Physiother. 2007;53(3):207. doi: 10.1016/s0004-9514(07)70032-6. No abstract available.
Leggin BG, Michener LA, Shaffer MA, Brenneman SK, Iannotti JP, Williams GR Jr. The Penn shoulder score: reliability and validity. J Orthop Sports Phys Ther. 2006 Mar;36(3):138-51. doi: 10.2519/jospt.2006.36.3.138.
Takamoto K, Hori E, Urakawa S, Sakai S, Ishikawa A, Kohno S, Ono T, Nishijo H. Cerebral hemodynamic responses induced by specific acupuncture sensations during needling at trigger points: a near-infrared spectroscopic study. Brain Topogr. 2010 Sep;23(3):279-91. doi: 10.1007/s10548-010-0148-8. Epub 2010 May 26.
Huppert TJ. Commentary on the statistical properties of noise and its implication on general linear models in functional near-infrared spectroscopy. Neurophotonics. 2016 Jan;3(1):010401. doi: 10.1117/1.NPh.3.1.010401. Epub 2016 Mar 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
40037-0010-0001-0208
Identifier Type: OTHER
Identifier Source: secondary_id
C.2018.057d
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.