Effects of TENS Therapy Following Arthroscopic Knee Surgery

NCT01528228 | Completed Results

• 1 other identifier: TENS Study #110518-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Following standard of care procedures for arthroscopy knee surgery it is anticipated that Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and improve functional outcomes.

Conditions

Meniscus Tear

Outcome Measures

Primary Outcomes (1)

• Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.

  The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain

  Two weeks postoperatively.

Study Arms (2)

Structured TENS Therapy

ACTIVE COMPARATOR

This group will be given an active TENS unit to use.

Device: TENS Treatment with functional or disabled unit

Sham TENS Therapy

SHAM COMPARATOR

This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.

Device: TENS Treatment with functional or disabled unit

Interventions

TENS Treatment with functional or disabled unit DEVICE

TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.

Also known as: EMPI Select Pain Control System

Sham TENS Therapy; Structured TENS Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60
• BMI\<50
• No significant joint malalignment
• No significant ligamentous instability
• No significant radiographic joint space narrowing
• No prior significant knee surgery
• Unilateral knee surgery
• Not workman's compensation
• Planned knee arthroscopy for meniscectomy, chondroplasty or synovectomy

You may not qualify if:

• Age \<18 or \>60
• BMI \> 50
• Significant joint malalignment
• Significant ligamentous instability
• Significant radiographic joint space narrowing
• Prior significant knee surgery
• Bilateral knee surgery planned
• Worker's Compensation
• No planned knee arthroscopy for menisectomy, chondroplasty or synovectomy

Sponsors & Collaborators

• A.T. Still University of Health Sciences: lead

Study Sites (1)

North Missouri Sports Medicine and Orthopaedic Surgery

Kirksville, Missouri, 63501, United States

Location

Related Publications (46)

• Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. doi: 10.1016/s0883-5403(03)00458-3.

  PMID: 14716650 BACKGROUND

• Lewek M, Stevens J, Snyder-Mackler L. The use of electrical stimulation to increase quadriceps femoris muscle force in an elderly patient following a total knee arthroplasty. Phys Ther. 2001 Sep;81(9):1565-71. doi: 10.1093/ptj/81.9.1565.

  PMID: 11688592 BACKGROUND

• Paternostro-Sluga T, Fialka C, Alacamliogliu Y, Saradeth T, Fialka-Moser V. Neuromuscular electrical stimulation after anterior cruciate ligament surgery. Clin Orthop Relat Res. 1999 Nov;(368):166-75.

  PMID: 10613165 BACKGROUND

• Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.

  PMID: 9249122 BACKGROUND

• Hargreaves A, Lander J. Use of transcutaneous electrical nerve stimulation for postoperative pain. Nurs Res. 1989 May-Jun;38(3):159-61.

  PMID: 2785684 BACKGROUND

• Arvidsson I, Eriksson E. Postoperative TENS pain relief after knee surgery: objective evaluation. Orthopedics. 1986 Oct;9(10):1346-51. doi: 10.3928/0147-7447-19861001-06.

  PMID: 3490659 BACKGROUND

• Tyler E, Caldwell C, Ghia JN. Transcutaneous electrical nerve stimulation: an alternative approach to the management of postoperative pain. Anesth Analg. 1982 May;61(5):449-56. No abstract available.

  PMID: 6175251 BACKGROUND

• Neary JM. Transcutaneous electrical nerve stimulation for the relief of post-incisional surgical pain. AANA J. 1981 Apr;49(2):151-5. No abstract available.

  PMID: 6111884 BACKGROUND

• Cooperman AM, Hall B, Mikalacki K, Hardy R, Sardar E. Use of transcutaneous electrical stimulation in the control of postoperative pain. Am J Surg. 1977 Feb;133(2):185-7. doi: 10.1016/0002-9610(77)90077-0.

  PMID: 319697 BACKGROUND

• Selfe TK, Taylor AG. Acupuncture and osteoarthritis of the knee: a review of randomized, controlled trials. Fam Community Health. 2008 Jul-Sep;31(3):247-54. doi: 10.1097/01.FCH.0000324482.78577.0f.

  PMID: 18552606 BACKGROUND

• Eyigor S, Karapolat H, Ibisoglu U, Durmaz B. [Does transcutaneous electrical nerve stimulation or therapeutic ultrasound increase the effectiveness of exercise for knee osteoarthritis: a randomized controlled study]. Agri. 2008 Jan;20(1):32-40. Turkish.

  PMID: 18338277 BACKGROUND

• Cetin N, Aytar A, Atalay A, Akman MN. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. doi: 10.1097/PHM.0b013e318174e467.

  PMID: 18496246 BACKGROUND

• Burch FX, Tarro JN, Greenberg JJ, Carroll WJ. Evaluating the benefits of patterned stimulation in the treatment of osteoarthritis of the knee: a multi-center, randomized, single-blind, controlled study with an independent masked evaluator. Osteoarthritis Cartilage. 2008 Aug;16(8):865-72. doi: 10.1016/j.joca.2007.11.013. Epub 2008 Feb 8.

  PMID: 18262443 BACKGROUND

• Kang RW, Lewis PB, Kramer A, Hayden JK, Cole BJ. Prospective randomized single-blinded controlled clinical trial of percutaneous neuromodulation pain therapy device versus sham for the osteoarthritic knee: a pilot study. Orthopedics. 2007 Jun;30(6):439-45. doi: 10.3928/01477447-20070601-11. No abstract available.

  PMID: 17598487 BACKGROUND

• Paker N, Tekdos D, Kesiktas N, Soy D. Comparison of the therapeutic efficacy of TENS versus intra-articular hyaluronic acid injection in patients with knee osteoarthritis: a prospective randomized study. Adv Ther. 2006 Mar-Apr;23(2):342-53. doi: 10.1007/BF02850139.

  PMID: 16751166 BACKGROUND

• Bjordal JM, Lopes-Martins RA, Bogen B, Johnson M. Physical treatments have valuable role in osteoarthritis. BMJ. 2006 Apr 8;332(7545):853. doi: 10.1136/bmj.332.7545.853. No abstract available.

  PMID: 16601058 BACKGROUND

• Casimiro L, Barnsley L, Brosseau L, Milne S, Robinson VA, Tugwell P, Wells G. Acupuncture and electroacupuncture for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003788. doi: 10.1002/14651858.CD003788.pub2.

  PMID: 16235342 BACKGROUND

• Law PP, Cheing GL, Tsui AY. Does transcutaneous electrical nerve stimulation improve the physical performance of people with knee osteoarthritis? J Clin Rheumatol. 2004 Dec;10(6):295-9. doi: 10.1097/01.rhu.0000147047.77460.b0.

  PMID: 17043536 BACKGROUND

• Law PP, Cheing GL. Optimal stimulation frequency of transcutaneous electrical nerve stimulation on people with knee osteoarthritis. J Rehabil Med. 2004 Sep;36(5):220-5. doi: 10.1080/16501970410029834.

  PMID: 15626162 BACKGROUND

• Cheing GL, Hui-Chan CW. Would the addition of TENS to exercise training produce better physical performance outcomes in people with knee osteoarthritis than either intervention alone? Clin Rehabil. 2004 Aug;18(5):487-97. doi: 10.1191/0269215504cr760oa.

  PMID: 15293483 BACKGROUND

• Talbot LA, Gaines JM, Ling SM, Metter EJ. A home-based protocol of electrical muscle stimulation for quadriceps muscle strength in older adults with osteoarthritis of the knee. J Rheumatol. 2003 Jul;30(7):1571-8.

  PMID: 12858461 BACKGROUND

• Cheing GL, Tsui AY, Lo SK, Hui-Chan CW. Optimal stimulation duration of tens in the management of osteoarthritic knee pain. J Rehabil Med. 2003 Mar;35(2):62-8. doi: 10.1080/16501970306116.

  PMID: 12691335 BACKGROUND

• Hopkins J, Ingersoll CD, Edwards J, Klootwyk TE. Cryotherapy and Transcutaneous Electric Neuromuscular Stimulation Decrease Arthrogenic Muscle Inhibition of the Vastus Medialis After Knee Joint Effusion. J Athl Train. 2002 Mar;37(1):25-31.

  PMID: 12937440 BACKGROUND

• Cheing GL, Hui-Chan CW, Chan KM. Does four weeks of TENS and/or isometric exercise produce cumulative reduction of osteoarthritic knee pain? Clin Rehabil. 2002 Nov;16(7):749-60. doi: 10.1191/0269215502cr549oa.

  PMID: 12428824 BACKGROUND

• Osiri M, Welch V, Brosseau L, Shea B, McGowan J, Tugwell P, Wells G. Transcutaneous electrical nerve stimulation for knee osteoarthritis. Cochrane Database Syst Rev. 2000;(4):CD002823. doi: 10.1002/14651858.CD002823.

  PMID: 11034768 BACKGROUND

• Yurtkuran M, Kocagil T. TENS, electroacupuncture and ice massage: comparison of treatment for osteoarthritis of the knee. Am J Acupunct. 1999;27(3-4):133-40.

  PMID: 10729968 BACKGROUND

• Brandt KD. The importance of nonpharmacologic approaches in management of osteoarthritis. Am J Med. 1998 Jul 27;105(1B):39S-44S. doi: 10.1016/s0002-9343(98)00075-8.

  PMID: 9715833 BACKGROUND

• Hunt SA, Jazrawi LM, Sherman OH. Arthroscopic management of osteoarthritis of the knee. J Am Acad Orthop Surg. 2002 Sep-Oct;10(5):356-63. doi: 10.5435/00124635-200209000-00007.

  PMID: 12374486 BACKGROUND

• Taylor P, Hallett M, Flaherty L. Treatment of osteoarthritis of the knee with transcutaneous electrical nerve stimulation. Pain. 1981 Oct;11(2):233-240. doi: 10.1016/0304-3959(81)90008-7.

  PMID: 7033891 BACKGROUND

• Drosos GI, Stavropoulos NI, Katsis A, Kesidis K, Kazakos K, Verettas DA. Post-operative pain after knee arthroscopy and related factors. Open Orthop J. 2008 Jun 13;2:110-4. doi: 10.2174/1874325000802010110.

  PMID: 19478890 BACKGROUND

• Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002 Mar-Apr;10(2):117-29. doi: 10.5435/00124635-200203000-00007.

  PMID: 11929206 BACKGROUND

• Phillips WJ, Currier BL. Analgesic pharmacology: II. Specific analgesics. J Am Acad Orthop Surg. 2004 Jul-Aug;12(4):221-33. doi: 10.5435/00124635-200407000-00003.

  PMID: 15473674 BACKGROUND

• Phillips WJ, Currier BL. Analgesic pharmacology: I. Neurophysiology. J Am Acad Orthop Surg. 2004 Jul-Aug;12(4):213-20. doi: 10.5435/00124635-200407000-00002.

  PMID: 15473673 BACKGROUND

• Suzuki M, Yamada S, Inamura A, Omori Y, Kirimoto H, Sugimura S, Miyamoto M. Reliability and validity of measurements of knee extension strength obtained from nursing home residents with dementia. Am J Phys Med Rehabil. 2009 Nov;88(11):924-33. doi: 10.1097/PHM.0b013e3181ae1003.

  PMID: 19661779 BACKGROUND

• Mahony K, Hunt A, Daley D, Sims S, Adams R. Inter-tester reliability and precision of manual muscle testing and hand-held dynamometry in lower limb muscles of children with spina bifida. Phys Occup Ther Pediatr. 2009;29(1):44-59. doi: 10.1080/01942630802574858.

  PMID: 19197758 BACKGROUND

• Katz-Leurer M, Rottem H, Meyer S. Hand-held dynamometry in children with traumatic brain injury: within-session reliability. Pediatr Phys Ther. 2008 Fall;20(3):259-63. doi: 10.1097/PEP.0b013e3181824782.

  PMID: 18703964 BACKGROUND

• Bell DR, Padua DA, Clark MA. Muscle strength and flexibility characteristics of people displaying excessive medial knee displacement. Arch Phys Med Rehabil. 2008 Jul;89(7):1323-8. doi: 10.1016/j.apmr.2007.11.048.

  PMID: 18586134 BACKGROUND

• Lu TW, Hsu HC, Chang LY, Chen HL. Enhancing the examiner's resisting force improves the reliability of manual muscle strength measurements: comparison of a new device with hand-held dynamometry. J Rehabil Med. 2007 Nov;39(9):679-84. doi: 10.2340/16501977-0107.

  PMID: 17999004 BACKGROUND

• Crompton J, Galea MP, Phillips B. Hand-held dynamometry for muscle strength measurement in children with cerebral palsy. Dev Med Child Neurol. 2007 Feb;49(2):106-11. doi: 10.1111/j.1469-8749.2007.00106.x.

  PMID: 17253996 BACKGROUND

• O'Shea SD, Taylor NF, Paratz JD. Measuring muscle strength for people with chronic obstructive pulmonary disease: retest reliability of hand-held dynamometry. Arch Phys Med Rehabil. 2007 Jan;88(1):32-6. doi: 10.1016/j.apmr.2006.10.002.

  PMID: 17207672 BACKGROUND

• Bohannon RW. Hand-held dynamometry: adoption 1900-2005. Percept Mot Skills. 2006 Aug;103(1):3-4. doi: 10.2466/pms.103.1.3-4.

  PMID: 17037637 BACKGROUND

• Li RC, Jasiewicz JM, Middleton J, Condie P, Barriskill A, Hebnes H, Purcell B. The development, validity, and reliability of a manual muscle testing device with integrated limb position sensors. Arch Phys Med Rehabil. 2006 Mar;87(3):411-7. doi: 10.1016/j.apmr.2005.11.011.

  PMID: 16500178 BACKGROUND

• Roy MA, Doherty TJ. Reliability of hand-held dynamometry in assessment of knee extensor strength after hip fracture. Am J Phys Med Rehabil. 2004 Nov;83(11):813-8. doi: 10.1097/01.phm.0000143405.17932.78.

  PMID: 15502733 BACKGROUND

• Piao C, Yoshimoto N, Shitama H, Makino K, Wada F, Hachisuka K. Validity and reliability of the measurement of the quardriceps femoris muscle strength with a hand-held dynamometer on the affected side in hemiplegic patients. J UOEH. 2004 Mar 1;26(1):1-11. doi: 10.7888/juoeh.26.1.

  PMID: 15038067 BACKGROUND

• Taylor NF, Dodd KJ, Graham HK. Test-retest reliability of hand-held dynamometric strength testing in young people with cerebral palsy. Arch Phys Med Rehabil. 2004 Jan;85(1):77-80. doi: 10.1016/s0003-9993(03)00379-4.

  PMID: 14970972 BACKGROUND

• Wright RW. Knee injury outcomes measures. J Am Acad Orthop Surg. 2009 Jan;17(1):31-9. doi: 10.5435/00124635-200901000-00005.

  PMID: 19136425 BACKGROUND

Results Point of Contact

• Title: Corey Luebbering
• Organization: A.T. Still University

coreyluebbering@atsu.edu

660.626.2147

Study Officials

• Kevin Marberry, MD

  A.T. Still University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: July 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 11, 2019
• Results First Posted: January 11, 2019

Record last verified: 2019-01

Locations

US (1)