Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain

NCT02812459 | Completed

• 1 other identifier: ELECBACK_KT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low Back Pain

Keywords

Electrical Stimulation Therapy; Kinesio taping; Exercise

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month.

  The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability

  4 weeks

Secondary Outcomes (8)

• Change from baseline Oswestry Disability Index (ODI) at one month.

  4 weeks

• Change from baseline Visual Analogue Scale (VAS) at one month

  4 weeks

• Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month

  4 weeks

• Change from baseline Pressure pain thresholds (PPT) at one month

  4 weeks

• Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month

  4 weeks

Study Arms (2)

Kinesio taping plus exercise

EXPERIMENTAL

Kinesio taping application for low back plus back exercises.This protocol will be administered three a week for 4 weeks.

Other: Kinesio taping

Electrical stimulation plus exercise

ACTIVE COMPARATOR

Electrical stimulation for control pain applied in low back plus exercises.This protocol will be administered three a week for 4 weeks.

Other: Electrical Stimulation

Interventions

Kinesio taping OTHER

Kinesio taping is a new taping modality which act diminishing pain.

Kinesio taping plus exercise

Electrical Stimulation OTHER

Electrical stimulation therapy is a electrical current that allow patients diminish pain.

Electrical stimulation plus exercise

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Adelaida Mª Castro Sánchez

Almería, S/N, Spain

Location

Related Publications (22)

• 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.

  PMID: 19881004 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 23065907 BACKGROUND

• 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.

  PMID: 11172169 RESULT

• 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.

  PMID: 16097556 RESULT

• 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.

  PMID: 24004738 RESULT

• 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.

  PMID: 22884183 RESULT

• 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.

  PMID: 19808766 RESULT

• 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.

  PMID: 27266883 RESULT

• 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.

  PMID: 26966819 RESULT

• 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.

  PMID: 26647750 RESULT

• 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.

  PMID: 26316553 RESULT

• 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.

  PMID: 25679343 RESULT

• 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.

  PMID: 25202177 RESULT

• 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.

  PMID: 24284272 RESULT

• 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.

  PMID: 27144300 RESULT

• 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.

  PMID: 27042787 RESULT

• 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.

  PMID: 26736024 RESULT

• 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.

  PMID: 26680409 RESULT

• 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.

  PMID: 26678446 RESULT

• 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.

  PMID: 26586248 RESULT

• 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.

  PMID: 35794120 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• María Encarnación Aguilar-Ferrándiz

  Deparment of Physical Therapy. University of Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 24, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

ES (1)