Skip to main content
Top
Published in: Trials 1/2024

Open Access 01-12-2024 | Back Pain | Study protocol

Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial

Authors: Richard E. Liebano, Kathleen A. Sluka, Joshua Roy, Meghan Savinelli, Dana L. Dailey, Sean P. Riley

Published in: Trials | Issue 1/2024

Login to get access

Abstract

Background

Low back pain (LBP) is a significant public health problem, is very prevalent, and is often characterized by the persistence of symptoms. Transcutaneous electrical nerve stimulation (TENS) may benefit people with chronic LBP because it can activate descending inhibitory pathways and inhibit central excitability. However, previous studies that have investigated the effects of TENS on pain in people with LBP have failed to use proper intensities of current, and the timing of the assessment of pain was not performed during the peak of the analgesic response or functional activities. Therefore, the present study aims to assess the effects of TENS on measures of pain, function, and descending inhibition using the maximal tolerable intensity of TENS in participants with LBP.

Methods/design

This study will be a randomized crossover trial. The participants for this study will be recruited from various places, including the University of Hartford, physical therapy clinics, and local businesses in the Hartford area, as well as online websites geared towards clinical trial recruitment. A total of 34 participants will receive all three treatments: active TENS, placebo TENS, and no treatment control. The treatment order will be randomized using a website-based randomization tool. For active TENS, a modulating frequency of 2–125 Hz will be applied with a variable pulse duration and maximal tolerable intensity for 30 min. The TENS will be left on for post-treatment testing to assess the effects during its maximally effective period for a total of 50 to 60 min. Furthermore, the intensity may be turned down if muscle twitching is present to ensure blinding of the evaluator. For placebo TENS, the unit will deliver current for 45 s, ramping to 0 in the last 15 s. The primary outcome will be pain intensity at rest and with movement, determined using the numerical pain rating scale. The secondary outcomes will be pressure pain threshold, heat pain threshold, temporal summation of pain, conditioned pain modulation, sit-to-stand test, and repeated trunk flexion. The assessments will be performed immediately before and after treatment. Statistical analysis of the data obtained will consider a significance level of p < 0.05.

Discussion

This study will provide evidence concerning the effects and mechanisms of TENS treatment in participants with chronic non-specific low back pain. The outcomes, including pain, function, and descending inhibition, will help us gain a greater understanding of how TENS can be used for these participants.

Trial registration

ClinicalTrials.gov NCT05812885. Registered on 24th May 2023.
Literature
1.
go back to reference Shafshak TS, Elnemr R. The visual analogue scale versus numerical rating scale in measuring pain severity and predicting disability in low back pain. J Clin Rheumatol. 2021;27(7):282–5.CrossRefPubMed Shafshak TS, Elnemr R. The visual analogue scale versus numerical rating scale in measuring pain severity and predicting disability in low back pain. J Clin Rheumatol. 2021;27(7):282–5.CrossRefPubMed
2.
go back to reference van der Gaag WH, Enthoven WTM, Luijsterburg PAJ, van Rijckevorsel-Scheele J, Bierma-Zeinstra SMA, Bohnen AM, et al. Natural history of back pain in older adults over five years. J Am Board Fam Med. 2019;32(6):781–9.CrossRefPubMed van der Gaag WH, Enthoven WTM, Luijsterburg PAJ, van Rijckevorsel-Scheele J, Bierma-Zeinstra SMA, Bohnen AM, et al. Natural history of back pain in older adults over five years. J Am Board Fam Med. 2019;32(6):781–9.CrossRefPubMed
3.
go back to reference Bento TPF, Genebra C, Maciel NM, Cornelio GP, Simeao S, Vitta A. Low back pain and some associated factors: is there any difference between genders? Braz J Phys Ther. 2020;24(1):79–87.CrossRefPubMed Bento TPF, Genebra C, Maciel NM, Cornelio GP, Simeao S, Vitta A. Low back pain and some associated factors: is there any difference between genders? Braz J Phys Ther. 2020;24(1):79–87.CrossRefPubMed
4.
go back to reference Zaina F, Cote P, Cancelliere C, Di Felice F, Donzelli S, Rauch A, et al. A systematic review of clinical practice guidelines for persons with non-specific low back pain with and without radiculopathy: identification of best evidence for rehabilitation to develop the WHO’s Package of Interventions for Rehabilitation. Arch Phys Med Rehabil. 2023;104(11):1913–27.CrossRefPubMed Zaina F, Cote P, Cancelliere C, Di Felice F, Donzelli S, Rauch A, et al. A systematic review of clinical practice guidelines for persons with non-specific low back pain with and without radiculopathy: identification of best evidence for rehabilitation to develop the WHO’s Package of Interventions for Rehabilitation. Arch Phys Med Rehabil. 2023;104(11):1913–27.CrossRefPubMed
5.
go back to reference Jensen OK, Nielsen CV, Stengaard-Pedersen K. Diffuse central sensitization in low back patients: a secondary analysis of cross-sectional data including tender point examination and magnetic resonance imaging of the lumbar spine. Medicine (Baltimore). 2020;99(38):e22198.CrossRefPubMed Jensen OK, Nielsen CV, Stengaard-Pedersen K. Diffuse central sensitization in low back patients: a secondary analysis of cross-sectional data including tender point examination and magnetic resonance imaging of the lumbar spine. Medicine (Baltimore). 2020;99(38):e22198.CrossRefPubMed
7.
go back to reference Harte SE, Harris RE, Clauw DJ. The neurobiology of central sensitization. J Appl Biobehav Res. 2018;23:e12137.CrossRef Harte SE, Harris RE, Clauw DJ. The neurobiology of central sensitization. J Appl Biobehav Res. 2018;23:e12137.CrossRef
8.
go back to reference Correa JB, Costa LO, de Oliveira NT, Sluka KA, Liebano RE. Central sensitization and changes in conditioned pain modulation in people with chronic nonspecific low back pain: a case-control study. Exp Brain Res. 2015;233(8):2391–9.CrossRefPubMedPubMedCentral Correa JB, Costa LO, de Oliveira NT, Sluka KA, Liebano RE. Central sensitization and changes in conditioned pain modulation in people with chronic nonspecific low back pain: a case-control study. Exp Brain Res. 2015;233(8):2391–9.CrossRefPubMedPubMedCentral
9.
go back to reference George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, et al. Interventions for the management of acute and chronic low back pain: revision 2021. J Orthop Sports Phys Ther. 2021;51(11):CPG1–60.CrossRefPubMedPubMedCentral George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, et al. Interventions for the management of acute and chronic low back pain: revision 2021. J Orthop Sports Phys Ther. 2021;51(11):CPG1–60.CrossRefPubMedPubMedCentral
10.
go back to reference Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, et al. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013;154(11):2554–62.CrossRefPubMedPubMedCentral Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, et al. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013;154(11):2554–62.CrossRefPubMedPubMedCentral
11.
go back to reference Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, et al. Transcutaneous electrical nerve stimulation reduces movement-evoked pain and fatigue: a randomized, controlled trial. Arthritis Rheumatol. 2020;72(5):824–36.CrossRefPubMedPubMedCentral Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, et al. Transcutaneous electrical nerve stimulation reduces movement-evoked pain and fatigue: a randomized, controlled trial. Arthritis Rheumatol. 2020;72(5):824–36.CrossRefPubMedPubMedCentral
12.
go back to reference Vance CGT, Dailey DL, Chimenti RL, Van Gorp BJ, Crofford LJ, Sluka KA. Using TENS for pain control: update on the state of the evidence. Medicina (Kaunas). 2022;58(10). Vance CGT, Dailey DL, Chimenti RL, Van Gorp BJ, Crofford LJ, Sluka KA. Using TENS for pain control: update on the state of the evidence. Medicina (Kaunas). 2022;58(10).
13.
go back to reference Leemans L, Elma O, Nijs J, Wideman TH, Siffain C, den Bandt H, et al. Transcutaneous electrical nerve stimulation and heat to reduce pain in a chronic low back pain population: a randomized controlled clinical trial. Braz J Phys Ther. 2021;25(1):86–96.CrossRefPubMed Leemans L, Elma O, Nijs J, Wideman TH, Siffain C, den Bandt H, et al. Transcutaneous electrical nerve stimulation and heat to reduce pain in a chronic low back pain population: a randomized controlled clinical trial. Braz J Phys Ther. 2021;25(1):86–96.CrossRefPubMed
14.
go back to reference Rakel B, Frantz R. Effectiveness of transcutaneous electrical nerve stimulation on postoperative pain with movement. J Pain. 2003;4(8):455–64.CrossRefPubMed Rakel B, Frantz R. Effectiveness of transcutaneous electrical nerve stimulation on postoperative pain with movement. J Pain. 2003;4(8):455–64.CrossRefPubMed
15.
go back to reference Berardi G, Dailey DL, Chimenti R, Merriwether E, Vance CGT, Rakel BA, et al. Influence of transcutaneous electrical nerve stimulation (TENS) on pressure pain thresholds and conditioned pain modulation in a randomized controlled trial in women with fibromyalgia. J Pain. 2023. Berardi G, Dailey DL, Chimenti R, Merriwether E, Vance CGT, Rakel BA, et al. Influence of transcutaneous electrical nerve stimulation (TENS) on pressure pain thresholds and conditioned pain modulation in a randomized controlled trial in women with fibromyalgia. J Pain. 2023.
16.
go back to reference Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.CrossRef Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.CrossRef
17.
18.
go back to reference Guimaraes LS, Costa L, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, et al. Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial. Pain. 2021;162(6):1612–20.CrossRefPubMed Guimaraes LS, Costa L, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, et al. Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial. Pain. 2021;162(6):1612–20.CrossRefPubMed
19.
go back to reference Simon CB, Riley JL 3rd, Fillingim RB, Bishop MD, George SZ. Age group comparisons of TENS response among individuals with chronic axial low back pain. J Pain. 2015;16(12):1268–79.CrossRefPubMedPubMedCentral Simon CB, Riley JL 3rd, Fillingim RB, Bishop MD, George SZ. Age group comparisons of TENS response among individuals with chronic axial low back pain. J Pain. 2015;16(12):1268–79.CrossRefPubMedPubMedCentral
20.
go back to reference Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011;63(Suppl 11):S240–52.PubMed Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011;63(Suppl 11):S240–52.PubMed
21.
go back to reference Novy DM, Simmonds MJ, Lee CE. Physical performance tasks: what are the underlying constructs? Arch Phys Med Rehabil. 2002;83(1):44–7.CrossRefPubMed Novy DM, Simmonds MJ, Lee CE. Physical performance tasks: what are the underlying constructs? Arch Phys Med Rehabil. 2002;83(1):44–7.CrossRefPubMed
22.
go back to reference Simmonds MJ, Olson SL, Jones S, Hussein T, Lee CE, Novy D, et al. Psychometric characteristics and clinical usefulness of physical performance tests in patients with low back pain. Spine (Phila Pa 1976). 1998;23(22):2412–21.CrossRefPubMed Simmonds MJ, Olson SL, Jones S, Hussein T, Lee CE, Novy D, et al. Psychometric characteristics and clinical usefulness of physical performance tests in patients with low back pain. Spine (Phila Pa 1976). 1998;23(22):2412–21.CrossRefPubMed
23.
go back to reference Lee CE, Simmonds MJ, Novy DM, Jones S. Self-reports and clinician-measured physical function among patients with low back pain: a comparison. Arch Phys Med Rehabil. 2001;82(2):227–31.CrossRefPubMed Lee CE, Simmonds MJ, Novy DM, Jones S. Self-reports and clinician-measured physical function among patients with low back pain: a comparison. Arch Phys Med Rehabil. 2001;82(2):227–31.CrossRefPubMed
24.
go back to reference Meeus M, Roussel NA, Truijen S, Nijs J. Reduced pressure pain thresholds in response to exercise in chronic fatigue syndrome but not in chronic low back pain: an experimental study. J Rehabil Med. 2010;42(9):884–90.CrossRefPubMed Meeus M, Roussel NA, Truijen S, Nijs J. Reduced pressure pain thresholds in response to exercise in chronic fatigue syndrome but not in chronic low back pain: an experimental study. J Rehabil Med. 2010;42(9):884–90.CrossRefPubMed
25.
go back to reference Schenk P, Laeubli T, Klipstein A. Validity of pressure pain thresholds in female workers with and without recurrent low back pain. Eur Spine J. 2007;16(2):267–75.CrossRefPubMed Schenk P, Laeubli T, Klipstein A. Validity of pressure pain thresholds in female workers with and without recurrent low back pain. Eur Spine J. 2007;16(2):267–75.CrossRefPubMed
26.
go back to reference Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, et al. Sensitization in patients with painful knee osteoarthritis. Pain. 2010;149(3):573–81.CrossRefPubMed Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, et al. Sensitization in patients with painful knee osteoarthritis. Pain. 2010;149(3):573–81.CrossRefPubMed
27.
go back to reference O’Neill S, Kjaer P, Graven-Nielsen T, Manniche C, Arendt-Nielsen L. Low pressure pain thresholds are associated with, but does not predispose for, low back pain. Eur Spine J. 2011;20(12):2120–5.CrossRefPubMedPubMedCentral O’Neill S, Kjaer P, Graven-Nielsen T, Manniche C, Arendt-Nielsen L. Low pressure pain thresholds are associated with, but does not predispose for, low back pain. Eur Spine J. 2011;20(12):2120–5.CrossRefPubMedPubMedCentral
28.
go back to reference Nim CG, O’Neill S, Geltoft AG, Jensen LK, Schiottz-Christensen B, Kawchuk GN. A cross-sectional analysis of persistent low back pain, using correlations between lumbar stiffness, pressure pain threshold, and heat pain threshold. Chiropr Man Therap. 2021;29(1):34.CrossRefPubMedPubMedCentral Nim CG, O’Neill S, Geltoft AG, Jensen LK, Schiottz-Christensen B, Kawchuk GN. A cross-sectional analysis of persistent low back pain, using correlations between lumbar stiffness, pressure pain threshold, and heat pain threshold. Chiropr Man Therap. 2021;29(1):34.CrossRefPubMedPubMedCentral
29.
go back to reference Knutti IA, Suter MR, Opsommer E. Test-retest reliability of thermal quantitative sensory testing on two sites within the L5 dermatome of the lumbar spine and lower extremity. Neurosci Lett. 2014;579:157–62.CrossRefPubMed Knutti IA, Suter MR, Opsommer E. Test-retest reliability of thermal quantitative sensory testing on two sites within the L5 dermatome of the lumbar spine and lower extremity. Neurosci Lett. 2014;579:157–62.CrossRefPubMed
30.
go back to reference Cathcart S, Winefield AH, Rolan P, Lushington K. Reliability of temporal summation and diffuse noxious inhibitory control. Pain Res Manag. 2009;14(6):433–8.CrossRefPubMedPubMedCentral Cathcart S, Winefield AH, Rolan P, Lushington K. Reliability of temporal summation and diffuse noxious inhibitory control. Pain Res Manag. 2009;14(6):433–8.CrossRefPubMedPubMedCentral
31.
go back to reference Knudsen L, Drummond PD. Cold-induced limb pain decreases sensitivity to pressure-pain sensations in the ipsilateral forehead. Eur J Pain. 2009;13(10):1023–9.CrossRefPubMed Knudsen L, Drummond PD. Cold-induced limb pain decreases sensitivity to pressure-pain sensations in the ipsilateral forehead. Eur J Pain. 2009;13(10):1023–9.CrossRefPubMed
32.
go back to reference Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Cano A, et al. Minimal clinically important change for pain intensity and disability in patients with nonspecific low back pain. Spine (Phila Pa 1976). 2007;32(25):2915–20.CrossRefPubMed Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Cano A, et al. Minimal clinically important change for pain intensity and disability in patients with nonspecific low back pain. Spine (Phila Pa 1976). 2007;32(25):2915–20.CrossRefPubMed
33.
go back to reference Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. New Jersey: Lawrence Erlbaum Associates; 1988. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. New Jersey: Lawrence Erlbaum Associates; 1988.
34.
go back to reference Wan Z, Xia X, Lo D, Murphy GC. How does machine learning change software development practices? IEEE Trans Softw Eng. 2021;47(9):1857–71. Wan Z, Xia X, Lo D, Murphy GC. How does machine learning change software development practices? IEEE Trans Softw Eng. 2021;47(9):1857–71.
35.
go back to reference Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162.CrossRefPubMedPubMedCentral Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162.CrossRefPubMedPubMedCentral
36.
go back to reference Johnson MI, Paley CA, Jones G, Mulvey MR, Wittkopf PG. Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). BMJ Open. 2022;12(2):e051073.CrossRefPubMedPubMedCentral Johnson MI, Paley CA, Jones G, Mulvey MR, Wittkopf PG. Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). BMJ Open. 2022;12(2):e051073.CrossRefPubMedPubMedCentral
37.
go back to reference 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;322(23):1627–34.CrossRefPubMed 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;322(23):1627–34.CrossRefPubMed
Metadata
Title
Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial
Authors
Richard E. Liebano
Kathleen A. Sluka
Joshua Roy
Meghan Savinelli
Dana L. Dailey
Sean P. Riley
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08089-7

Other articles of this Issue 1/2024

Trials 1/2024 Go to the issue