Clinical trial NCT02812459: Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain
Official title: Short-term Effectiveness of Additional Electrical Stimulation to Exercise Versus Kinesio Taping in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Electrical Stimulation Therapy
Kinesio taping
Exercise
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 62
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the effectiveness of electrical stimulation and kinesio taping in combination with exercise in People with Chronic Low Back Pain


Eligibility criteria: Inclusion Criteria:

1. LBP for three months or more;
2. age between 25 and 65 years;
3. a score of four points or more on the Roland Morris Disability Questionnaire;
4. not currently receiving physical therapy.

Exclusion Criteria:

1. the presence of lumbar stenosis;
2. any clinical signs of radiculopathy;
3. a diagnosis of spondylolisthesis;
4. a diagnosis of fibromyalgia;
5. treatment with corticosteroid or oral medication within the past two weeks;
6. a history of spinal surgery;
7. disease of the central or peripheral nervous system.

Primary outcomes:
measure: Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline Oswestry Disability Index (ODI) at one month.
timeFrame: 4 weeks
measure: Change from baseline Visual Analogue Scale (VAS) at one month
timeFrame: 4 weeks
measure: Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month
timeFrame: 4 weeks
measure: Change from baseline Pressure pain thresholds (PPT) at one month
timeFrame: 4 weeks
measure: Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month
timeFrame: 4 weeks
measure: Change from baseline Mechanosensitive/straight-leg raise neurodynamic testing at one month
timeFrame: 4 weeks
measure: Change from baseline Anxiety and depression measures at one month
timeFrame: 4 weeks
measure: Change from baseline Quality of Sleep at one month
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Adelaida Mª Castro Sánchez
Study officials:
affiliation: Deparment of Physical Therapy. University of Granada
name: María Encarnación Aguilar-Ferrándiz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boyd BS, Wanek L, Gray AT, Topp KS. Mechanosensitivity of the lower extremity nervous system during straight-leg raise neurodynamic testing in healthy individuals. J Orthop Sports Phys Ther. 2009 Nov;39(11):780-90. doi: 10.2519/jospt.2009.3002.
citation: 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.
citation: Sipko T, Kuczynski M. Intensity of chronic pain modifies postural control in low back patients. Eur J Pain. 2013 Apr;17(4):612-20. doi: 10.1002/j.1532-2149.2012.00226.x.
citation: Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.
citation: Ekman M, Johnell O, Lidgren L. The economic cost of low back pain in Sweden in 2001. Acta Orthop. 2005 Apr;76(2):275-84. doi: 10.1080/00016470510030698.
citation: Melloh M, Elfering A, Stanton TR, Kaser A, Salathe CR, Barz T, Roder C, Theis JC. Who is likely to develop persistent low back pain? A longitudinal analysis of prognostic occupational factors. Work. 2013 Jan 1;46(3):297-311. doi: 10.3233/WOR-131672.
citation: Hallegraeff JM, Krijnen WP, van der Schans CP, de Greef MH. Expectations about recovery from acute non-specific low back pain predict absence from usual work due to chronic low back pain: a systematic review. J Physiother. 2012;58(3):165-72. doi: 10.1016/S1836-9553(12)70107-8.
citation: Costa Lda C, Maher CG, McAuley JH, Hancock MJ, Herbert RD, Refshauge KM, Henschke N. Prognosis for patients with chronic low back pain: inception cohort study. BMJ. 2009 Oct 6;339:b3829. doi: 10.1136/bmj.b3829.
citation: Added MA, Costa LO, de Freitas DG, Fukuda TY, Monteiro RL, Salomao EC, de Medeiros FC, Costa Lda C. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Jul;46(7):506-13. doi: 10.2519/jospt.2016.6590. Epub 2016 Jun 6.
citation: Forozeshfard M, Bakhtiary AH, Aminianfar A, Sheikhian S, Akbarzadeh Z. Short term effects of kinesio taping on pain and functional disability in young females with menstrual low back pain: A randomised control trial study. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):709-715. doi: 10.3233/BMR-160673.
citation: Luz Junior MA, Sousa MV, Neves LA, Cezar AA, Costa LO. Kinesio Taping(R) is not better than placebo in reducing pain and disability in patients with chronic non-specific low back pain: a randomized controlled trial. Braz J Phys Ther. 2015 Nov-Dec;19(6):482-90. doi: 10.1590/bjpt-rbf.2014.0128. Epub 2015 Oct 9.
citation: Kelle B, Guzel R, Sakalli H. The effect of Kinesio taping application for acute non-specific low back pain: a randomized controlled clinical trial. Clin Rehabil. 2016 Oct;30(10):997-1003. doi: 10.1177/0269215515603218. Epub 2015 Aug 27.
citation: Hagen L, Hebert JJ, Dekanich J, Koppenhaver S. The effect of elastic therapeutic taping on back extensor muscle endurance in patients with low back pain: a randomized, controlled, crossover trial. J Orthop Sports Phys Ther. 2015 Mar;45(3):215-9. doi: 10.2519/jospt.2015.5177. Epub 2015 Feb 13.
citation: Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
citation: Alvarez-Alvarez S, Jose FG, Rodriguez-Fernandez AL, Gueita-Rodriguez J, Waller BJ. Effects of Kinesio(R) Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects. J Back Musculoskelet Rehabil. 2014;27(2):203-12. doi: 10.3233/BMR-130437.
citation: Elserty N, Kattabei O, Elhafez H. Effect of Fixed Versus Adjusted Transcutaneous Electrical Nerve Stimulation Amplitude on Chronic Mechanical Low Back Pain. J Altern Complement Med. 2016 Jul;22(7):557-62. doi: 10.1089/acm.2015.0063. Epub 2016 May 4.
citation: Jauregui JJ, Cherian JJ, Gwam CU, Chughtai M, Mistry JB, Elmallah RK, Harwin SF, Bhave A, Mont MA. A Meta-Analysis of Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain. Surg Technol Int. 2016 Apr;28:296-302.
citation: Hicks GE, Sions JM, Velasco TO, Manal TJ. Trunk Muscle Training Augmented With Neuromuscular Electrical Stimulation Appears to Improve Function in Older Adults With Chronic Low Back Pain: A Randomized Preliminary Trial. Clin J Pain. 2016 Oct;32(10):898-906. doi: 10.1097/AJP.0000000000000348.
citation: Pivec R, Minshall ME, Mistry JB, Chughtai M, Elmallah RK, Mont MA. Decreased Opioid Utilization and Cost at One Year in Chronic Low Back Pain Patients Treated with Transcutaneous Electric Nerve Stimulation (TENS). Surg Technol Int. 2015 Nov;27:268-74.
citation: Gladwell PW, Badlan K, Cramp F, Palmer S. Problems, Solutions, and Strategies Reported by Users of Transcutaneous Electrical Nerve Stimulation for Chronic Musculoskeletal Pain: Qualitative Exploration Using Patient Interviews. Phys Ther. 2016 Jul;96(7):1039-48. doi: 10.2522/ptj.20150272. Epub 2015 Dec 17.
citation: Frahm KS, Hennings K, Vera-Portocarrero L, Wacnik PW, Morch CD. Nerve Fiber Activation During Peripheral Nerve Field Stimulation: Importance of Electrode Orientation and Estimation of Area of Paresthesia. Neuromodulation. 2016 Apr;19(3):311-8. doi: 10.1111/ner.12371. Epub 2015 Nov 19.
citation: Aguilar-Ferrandiz ME, Mataran-Penarrocha GA, Tapia-Haro RM, Castellote-Caballero Y, Marti-Garcia C, Castro-Sanchez AM. Effects of a supervised exercise program in addition to electrical stimulation or kinesio taping in low back pain: a randomized controlled trial. Sci Rep. 2022 Jul 6;12(1):11430. doi: 10.1038/s41598-022-14154-5.