Study Summary
This trial will use a pre-test post-test research design to investigate whether dry needling (DN) has an effect on cortical excitability in patients with chronic low back pain (CLBP), specifically in patients who have developed central sensitization (CS).
Eligible Conditions
- Lower Back Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: Before and immediately after the intervention
Before and immediately after the intervention
Amplitude of motor evoked potential
Conditioned pain modulation
Intracortical facilitation
Pressure pain threshold
Short-interval intracortical inhibition
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Dry needling
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: Dry needling · No Placebo Group · N/A
Dry needling
Procedure
Experimental Group · 1 Intervention: Dry needling · Intervention Types: ProcedureTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dry needling
2017
N/A
~1100
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: before and immediately after the intervention
Who is running the clinical trial?
University of Texas Southwestern Medical CenterOTHER
951 Previous Clinical Trials
607,770 Total Patients Enrolled
American Academy of Orthopaedic Manual Physical TherapistsOTHER
2 Previous Clinical Trials
123 Total Patients Enrolled
Texas Woman's UniversityLead Sponsor
78 Previous Clinical Trials
5,347 Total Patients Enrolled
Sharon Wang-PricePrincipal InvestigatorTexas Woman's University
2 Previous Clinical Trials
100 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have chronic low back pain primarily in the L4-5 area that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months.
Who else is applying?
What state do they live in?
| Texas | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Fritz, Julie M, and James J Irrgang. 2001. “A Comparison of a Modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/81.2.776.
- Geva, Nirit, and Ruth Defrin. 2018. “Opposite Effects of Stress on Pain Modulation Depend on the Magnitude of Individual Stress Response”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2017.11.011.
- da Graca-Tarragó, Maria, Alícia Deitos, Aline Patrícia Brietzke, Iraci L. S. Torres, Luciana Cadore Stefani, Felipe Fregni, and Wolnei Caumo. 2015. “Electrical Intramuscular Stimulation in Osteoarthritis Enhances the Inhibitory Systems in Pain Processing at Cortical and Cortical Spinal System”. Pain Medicine. Oxford University Press (OUP). doi:10.1111/pme.12930.
- Neblett, Randy, Howard Cohen, YunHee Choi, Meredith M. Hartzell, Mark Williams, Tom G. Mayer, and Robert J. Gatchel. 2013. “The Central Sensitization Inventory (CSI): Establishing Clinically Significant Values for Identifying Central Sensitivity Syndromes in an Outpatient Chronic Pain Sample”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2012.11.012.
- Kiesel, Kyle B., Tim Uhl, Frank B. Underwood, and Arthur J. Nitz. 2008. “Rehabilitative Ultrasound Measurement of Select Trunk Muscle Activation During Induced Pain”. Manual Therapy. Elsevier BV. doi:10.1016/j.math.2006.10.003.
- Djordjevic, Olivera, Ljubica Konstantinovic, Nadica Miljkovic, and Goran Bijelic. 2015. “Relationship Between Electromyographic Signal Amplitude and Thickness Change of the Trunk Muscles in Patients with and Without Low Back Pain”. The Clinical Journal of Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ajp.0000000000000179.
- Dunning, James, Raymond Butts, Firas Mourad, Ian Young, Sean Flannagan, and Thomas Perreault. 2014. “Dry Needling: A Literature Review with Implications for Clinical Practice Guidelines”. Physical Therapy Reviews. Informa UK Limited. doi:10.1179/108331913x13844245102034.
- Levy, Dan, Lorin Abdian, Michal Dekel-Steinkeller, and Ruth Defrin. 2017. “Experimental Evidence for Weaker Endogenous Inhibition of Trigeminal Pain Than Extra-trigeminal Pain in Healthy Individuals”. Cephalalgia. SAGE Publications. doi:10.1177/0333102417735851.
- Persson, Ann, Christina Brogårdh, and Bengt Sjölund. 2004. “Tender or Not Tender: Test-retest Repeatability of Pressure Pain Thresholds in the Trapezius and Deltoid Muscles of Healthy Women”. Journal of Rehabilitation Medicine. Medical Journals Sweden AB. doi:10.1080/16501970310015218.
- Massé-Alarie, Hugo, Louis-David Beaulieu, Richard Preuss, and Cyril Schneider. 2015. “Corticomotor Control of Lumbar Multifidus Muscles Is Impaired in Chronic Low Back Pain: Concurrent Evidence from Ultrasound Imaging and Double-pulse Transcranial Magnetic Stimulation”. Experimental Brain Research. Springer Science and Business Media LLC. doi:10.1007/s00221-015-4528-x.
- Chesterton, Linda S., Julius Sim, Christine C. Wright, and Nadine E. Foster. 2007. “Interrater Reliability of Algometry in Measuring Pressure Pain Thresholds in Healthy Humans, Using Multiple Raters”. The Clinical Journal of Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ajp.0b013e318154b6ae.
- Koppenhaver, Shane L., Michael J. Walker, Jonathan Su, Jared M. McGowen, Lindsey Umlauf, Kevin D. Harris, and Michael D. Ross. 2015. “Changes in Lumbar Multifidus Muscle Function and Nociceptive Sensitivity in Low Back Pain Patient Responders Versus Non-responders After Dry Needling Treatment”. Manual Therapy. Elsevier BV. doi:10.1016/j.math.2015.03.003.
- Magerl, Walter, Elena K. Krumova, Ralf Baron, Thomas Tölle, Rolf-Detlef Treede, and Christoph Maier. 2010. “Reference Data for Quantitative Sensory Testing (QST): Refined Stratification for Age and a Novel Method for Statistical Comparison of Group Data”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.pain.2010.07.026.
- Tsao, Henry, Lieven A. Danneels, and Paul W. Hodges. 2011. “ISSLS Prize Winner”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/brs.0b013e31821c4267.
- Deyo, Richard A., Katrina Ramsey, David I. Buckley, LeAnn Michaels, Amy Kobus, Elizabeth Eckstrom, Vanessa Forro, and Cynthia Morris. 2015. “Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain”. Pain Medicine. Oxford University Press (OUP). doi:10.1093/pm/pnv046.
- Wang-Price, Sharon, Jason Zafereo, Zach Couch, Kelli Brizzolara, Taylor Heins, and Lindsey Smith. 2020. “Short-term Effects of Two Deep Dry Needling Techniques on Pressure Pain Thresholds and Electromyographic Amplitude of the Lumbosacral Multifidus in Patients with Low Back Pain - a Randomized Clinical Trial”. Journal of Manual & Manipulative Therapy. Informa UK Limited. doi:10.1080/10669817.2020.1714165.
- Deyo, Richard A., Samuel F. Dworkin, Dagmar Amtmann, Gunnar Andersson, David Borenstein, Eugene Carragee, John Carrino, et al.. 2014. “Report of the NIH Task Force on Research Standards for Chronic Low Back Pain”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2014.03.005.
- Sung, Won, Gregory E. Hicks, David Ebaugh, Susan S. Smith, Scott Stackhouse, Peemongkon Wattananon, and Sheri P. Silfies. 2019. “Individuals with and Without Low Back Pain Use Different Motor Control Strategies to Achieve Spinal Stiffness During the Prone Instability Test”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2019.8577.
- Magerl W, Krumova EK, Baron R, Tolle T, Treede RD, Maier C. Reference data for quantitative sensory testing (QST): refined stratification for age and a novel method for statistical comparison of group data. Pain. 2010 Dec;151(3):598-605. doi: 10.1016/j.pain.2010.07.026. Epub 2010 Oct 20.
- 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. Erratum In: Phys Ther. 2008 Jan;88(1):138-9.
- 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.
- Chesterton LS, Sim J, Wright CC, Foster NE. Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters. Clin J Pain. 2007 Nov-Dec;23(9):760-6. doi: 10.1097/AJP.0b013e318154b6ae.
- da Graca-Tarrago M, Deitos A, Patricia Brietzke A, Torres IL, Cadore Stefani L, Fregni F, Caumo W. Electrical Intramuscular Stimulation in Osteoarthritis Enhances the Inhibitory Systems in Pain Processing at Cortical and Cortical Spinal System. Pain Med. 2016 May 1;17(5):877-891. doi: 10.1111/pme.12930. Epub 2015 Sep 23.
- Kiesel KB, Uhl T, Underwood FB, Nitz AJ. Rehabilitative ultrasound measurement of select trunk muscle activation during induced pain. Man Ther. 2008 May;13(2):132-8. doi: 10.1016/j.math.2006.10.003. Epub 2007 Jan 2.
- Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046.
- Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. Corticomotor control of lumbar multifidus muscles is impaired in chronic low back pain: concurrent evidence from ultrasound imaging and double-pulse transcranial magnetic stimulation. Exp Brain Res. 2016 Apr;234(4):1033-45. doi: 10.1007/s00221-015-4528-x. Epub 2015 Dec 26.
- Persson AL, Brogardh C, Sjolund BH. Tender or not tender: test-retest repeatability of pressure pain thresholds in the trapezius and deltoid muscles of healthy women. J Rehabil Med. 2004 Jan;36(1):17-27. doi: 10.1080/16501970310015218.
- Sharon Wang-Price 2022. "Dry Needling Effects on Cortical Excitability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05111691.
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