Dry Needling Effects on Cortical Excitability

NCT05111691 | Unknown

• 1 other identifier: IRB-FY2021-370
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to 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). Therefore, the primary purpose of this study is to examine the immediate effects of a single session of DN on cortical excitability and neurosensory responses in patients CLBP. There are two specific aims: 1) to examine whether a single session of DN will change cortical excitability corresponding to the lumbar multifidus (LM) muscle, and 2) to examine whether a single session of DN will change neurosensory responses to the stimuli applied to the LM muscles. The investigators also are interested in exploring whether DN has a differential effect on cortical excitability in patients with CLBP who have developed CS vs. those who have not developed CS. Therefore, the secondary purpose of the study is to compare the immediate effects of a single session of DN on cortical excitability between patients with CLBP who have developed central sensitization (CS) and those who do not have CS. The specific aim is to compare cortical excitability corresponding to the LM in participants with and without CS after a single session of DN.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• Amplitude of motor evoked potential

  Amplitude (uV) of motor evoked potential (MEP) will be obtained from the lumbar multifidus muscle during a submaximal contraction (i.e., 20% maximum voluntary isometric contractions) at a stimulus intensity of 130% of active motor threshold (AMT). AMT is defined as the transcranial magnetic stimulation intensity which yields a peak-to-peak amplitude of MEP larger than 200 μV in 5 out of 10 consecutive trials.

  Before and immediately after the intervention

• Intracortical facilitation

  Intracortical facilitation (%) is a ratio of the amplitude of the conditioned MEP relative to the amplitude of the corresponding test MEP. A subthreshold conditioning (second) TMS at the 90% AMT will be delivered 15 ms after a test (first) TMS at the 100% AMT.

  Before and immediately after the intervention

• Short-interval intracortical inhibition

  Short-interval intracortical inhibition (%) is a ratio of the amplitude of the conditioned MEP relative to the amplitude of the corresponding test MEP. A subthreshold conditioning (first) TMS at 70% AMT will be delivered 2 ms before a test TMS at a supra-threshold test TMS at 120% AMT.

  Before and immediately after the intervention

Secondary Outcomes (2)

• Pressure pain threshold

  Before and immediately after the intervention

• Conditioned pain modulation

  Before and immediately after the intervention

Study Arms (1)

Dry needling

EXPERIMENTAL

Two needles will be inserted on or near the most tender point of the low back. Two additional needles will be inserted on the opposite side at the level of the most tender point regardless of unilateral or bilateral low back pain (LBP). After piercing the skin, the needle will be directed toward the spinous process in a slight inferior-medial angle (approximately 20-30°). Once the needle is inserted, the treating investigator will use a ultrasound scanner to visualize the needle placement and to confirm that needle has reached the deeper layer of the lumbar multifidus (LM) muscle. Once the needle placement is confirmed, it will be pulled slightly in and out within the muscle and redirected in small angles for 10 seconds after insertion. The needles will stay (in situ) in the LM for approximately 10 minutes after the insertion and then will be withdrawn.

Procedure: Dry needling

Interventions

Dry needling PROCEDURE

Dry needling

Dry needling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-65 years of age
• 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

You may not qualify if:

• Systemic joint disease (e.g. rheumatoid arthritis, psoriasis arthritis)
• Fracture
• Infection
• Tumor
• Neurological disorders (e.g., radiculopathy, myelopathy, cauda equina syndrome)
• Cancer
• Raynaud's disease
• Pregnancy, previous low back surgery
• Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
• Bleeding disorders (e.g. hemophilia)
• Use of anti-coagulants (e.g. Coumadin)
• A history of significant head trauma
• An electrical, magnetic, or mechanical implantation (e.g. cardiac pacemakers or intracerebral vascular clip)
• A metal implantation in the head and neck areas,
• A history of seizures or unexplained loss of consciousness

Sponsors & Collaborators

• Texas Woman's University: lead
• University of Texas Southwestern Medical Center: collaborator
• American Academy of Orthopaedic Manual Physical Therapists: collaborator

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (18)

• 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.

  PMID: 26398594 RESULT

• Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13.

  PMID: 23490634 RESULT

• 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.

  PMID: 11175676 RESULT

• 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.

  PMID: 26814279 RESULT

• 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.

  PMID: 26708518 RESULT

• Tsao H, Danneels LA, Hodges PW. ISSLS prize winner: Smudging the motor brain in young adults with recurrent low back pain. Spine (Phila Pa 1976). 2011 Oct 1;36(21):1721-7. doi: 10.1097/BRS.0b013e31821c4267.

  PMID: 21508892 RESULT

• 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.

  PMID: 17198763 RESULT

• Djordjevic O, Konstantinovic L, Miljkovic N, Bijelic G. Relationship Between Electromyographic Signal Amplitude and Thickness Change of the Trunk Muscles in Patients With and Without Low Back Pain. Clin J Pain. 2015 Oct;31(10):893-902. doi: 10.1097/AJP.0000000000000179.

  PMID: 25380224 RESULT

• Sung W, Hicks GE, Ebaugh D, Smith SS, Stackhouse S, Wattananon P, Silfies SP. Individuals With and Without Low Back Pain Use Different Motor Control Strategies to Achieve Spinal Stiffness During the Prone Instability Test. J Orthop Sports Phys Ther. 2019 Dec;49(12):899-907. doi: 10.2519/jospt.2019.8577. Epub 2019 Aug 3.

  PMID: 31378122 RESULT

• 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.

  PMID: 18075402 RESULT

• 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.

  PMID: 15074434 RESULT

• Geva N, Defrin R. Opposite Effects of Stress on Pain Modulation Depend on the Magnitude of Individual Stress Response. J Pain. 2018 Apr;19(4):360-371. doi: 10.1016/j.jpain.2017.11.011. Epub 2017 Dec 11.

  PMID: 29241836 RESULT

• Levy D, Abdian L, Dekel-Steinkeller M, Defrin R. Experimental evidence for weaker endogenous inhibition of trigeminal pain than extra-trigeminal pain in healthy individuals. Cephalalgia. 2018 Jun;38(7):1307-1315. doi: 10.1177/0333102417735851. Epub 2017 Oct 9.

  PMID: 28990805 RESULT

• 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.

  PMID: 25801100 RESULT

• Wang-Price S, Zafereo J, Couch Z, Brizzolara K, Heins T, Smith L. 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. J Man Manip Ther. 2020 Dec;28(5):254-265. doi: 10.1080/10669817.2020.1714165. Epub 2020 Jan 17.

  PMID: 31960773 RESULT

• 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: 25143704 RESULT

• Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.

  PMID: 24787228 RESULT

• 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.

  PMID: 20965658 RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Sharon Wang-Price

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Wang-Price

CONTACT

2146897715; swang@twu.edu

Jason Zafereo

CONTACT

2146481002; Jason.Zafereo@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will receive the same dry needling intervention.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 8, 2021
• Study Start: March 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When the summary data are published. Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).

Locations

US (1)