TENS and Perioperative Fracture Patients

NCT04209673 | Completed

• 2 other identifiers: IRB0008225905-19-16E
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study designed to evaluate the effectiveness of TENS as part of post-operative pain management. Subjects receiving a TENS unit as part of clinical practice will be approached for consent and followed for 12 months.

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Opioid use

  Total amount of opioid use calculated by converting all opiates to Morphine Milligram Equivalents

  3 months following TENS unit placement

Secondary Outcomes (1)

• Change in patient-reported outcomes measurement information system (PROMIS 29) scores

  baseline and 3 months

Other Outcomes (3)

• Process Measures and Feasibility as measured by patient compliance- Usage

  3 months

• Process Measures and Feasibility as measured by patient compliance- Duration

  3 months

• Process Measures and Feasibility as measured by patient compliance-Frequency/amplitude

  3 months

Study Arms (2)

Transcutaneous nerve stimulation (TENS) patients

Patients who received a TENS unit after surgery

Other: Multimodal Pain management including TENS unit

No TENS

Historic controls- Patients who did not receive a TENS unit after surgery

Other: Multimodal Pain management not including TENS unit

Interventions

Multimodal Pain management including TENS unit OTHER

Patient receiving multimodal pain management strategies which includes the use of TENS.

Transcutaneous nerve stimulation (TENS) patients

Multimodal Pain management not including TENS unit OTHER

Patient receiving multimodal pain management strategies which does not includes the use of TENS.

No TENS

Eligibility Criteria

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

Study Population

This will be a prospective observational study of patients undergoing operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction. The study will be conducted at a single Level I trauma center. Enrolled patients will receive TENS postoperatively during hospitalization; TENS units will also be sent home with patients for use throughout recovery. This group will be compared to controls injury-matched from a prospectively collected, historical database on mobility who did not receive treatment with TENS.

You may qualify if:

• Operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction
• Injury or deformity of the femur, tibia (plateau, shaft, pilon), or hindfoot and ankle
• Isolated injury
• Age 18 years or older
• Able to provide consent

You may not qualify if:

• Unable to provide consent (no use of LAR)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center, Department of Orthopaedic Surgery

Charlotte, North Carolina, 28204, United States

Location

Related Publications (15)

• Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.

  PMID: 24519537 BACKGROUND

• Li J, Song Y. Transcutaneous electrical nerve stimulation for postoperative pain control after total knee arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Sep;96(37):e8036. doi: 10.1097/MD.0000000000008036.

  PMID: 28906393 BACKGROUND

• Tedesco D, Gori D, Desai KR, Asch S, Carroll IR, Curtin C, McDonald KM, Fantini MP, Hernandez-Boussard T. Drug-Free Interventions to Reduce Pain or Opioid Consumption After Total Knee Arthroplasty: A Systematic Review and Meta-analysis. JAMA Surg. 2017 Oct 18;152(10):e172872. doi: 10.1001/jamasurg.2017.2872. Epub 2017 Oct 18.

  PMID: 28813550 BACKGROUND

• Beckwee D, Bautmans I, Swinnen E, Vermet Y, Lefeber N, Lievens P, Vaes P. A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty. SAGE Open Med. 2014 Jun 16;2:2050312114539318. doi: 10.1177/2050312114539318. eCollection 2014.

  PMID: 26770730 BACKGROUND

• Mahure SA, Rokito AS, Kwon YW. Transcutaneous electrical nerve stimulation for postoperative pain relief after arthroscopic rotator cuff repair: a prospective double-blinded randomized trial. J Shoulder Elbow Surg. 2017 Sep;26(9):1508-1513. doi: 10.1016/j.jse.2017.05.030. Epub 2017 Jul 20.

  PMID: 28735847 BACKGROUND

• Lee CH, Lee TY, Her JS, Liao WL, Hsieh CL. Single-Blinded, Randomized Preliminary Study Evaluating the Effect of Transcutaneous Electrical Nerve Stimulation on Postoperative Pain in Patients with Colles' Fracture. J Altern Complement Med. 2015 Dec;21(12):754-8. doi: 10.1089/acm.2015.0119. Epub 2015 Oct 23.

  PMID: 26496205 BACKGROUND

• Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.

  PMID: 12600800 BACKGROUND

• Seymour RB, Leas D, Wally MK, Hsu JR; PRIMUM Group. Prescription reporting with immediate medication utilization mapping (PRIMUM): development of an alert to improve narcotic prescribing. BMC Med Inform Decis Mak. 2016 Aug 22;16(1):111. doi: 10.1186/s12911-016-0352-x. Erratum In: BMC Med Inform Decis Mak. 2016 Sep 26;16(1):125. doi: 10.1186/s12911-016-0364-6.

  PMID: 27549364 BACKGROUND

• Garland D, Holt P, Harrington JT, Caldwell J, Zizic T, Cholewczynski J. A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2007 Jun;15(6):630-7. doi: 10.1016/j.joca.2007.01.004. Epub 2007 Feb 15.

  PMID: 17303443 BACKGROUND

• Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamurthy S. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med. 1990 Jun 7;322(23):1627-34. doi: 10.1056/NEJM199006073222303.

  PMID: 2140432 BACKGROUND

• U. S. Food and Drug Administration/Center for Devices and Radiological Health. (2006). Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies : FDA public health advisory. Silver Spring, MD.

  BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Rakel BA, Zimmerman BM, Geasland K, Embree J, Clark CR, Noiseux NO, Callaghan JJ, Herr K, Walsh D, Sluka KA. Transcutaneous electrical nerve stimulation for the control of pain during rehabilitation after total knee arthroplasty: A randomized, blinded, placebo-controlled trial. Pain. 2014 Dec;155(12):2599-2611. doi: 10.1016/j.pain.2014.09.025. Epub 2014 Sep 28.

  PMID: 25270585 BACKGROUND

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 RESULT

• Jones I, Johnson MI. Transcutaneous electrical nerve stimulation. Continuing Education in Anaesthesia Critical Care & Pain. 2009;9(4):130-135.

  RESULT

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Hsu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 24, 2019
• Study Start: January 6, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)