- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02812459
Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain (ELECBACK)
October 4, 2018 updated by: Encarnación Aguilar Ferrandiz, Universidad de Granada
Short-term Effectiveness of Additional Electrical Stimulation to Exercise Versus Kinesio Taping in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Almería, Spain, S/N
- Adelaida Mª Castro Sánchez
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Kinesio taping plus exercise
Kinesio taping application for low back plus back exercises.This protocol will be administered three a week for 4 weeks.
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Kinesio taping is a new taping modality which act diminishing pain.
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ACTIVE_COMPARATOR: Electrical stimulation plus exercise
Electrical stimulation for control pain applied in low back plus exercises.This protocol will be administered three a week for 4 weeks.
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Electrical stimulation therapy is a electrical current that allow patients diminish pain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month.
Time Frame: 4 weeks
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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
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Oswestry Disability Index (ODI) at one month.
Time Frame: 4 weeks
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The Oswestry disability index evaluates daily life activity limitations in 10 dimensions, each scored on a 6-point scale (0-5 points); the total points scored are expressed as a percentage, used to classify individuals as minimally disabled (0-10%), moderately disabled (20-40%), severely disabled (40-60%), crippled (60-80%), or bedbound (80-100%).
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4 weeks
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Change from baseline Visual Analogue Scale (VAS) at one month
Time Frame: 4 weeks
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The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain
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4 weeks
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Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month
Time Frame: 4 weeks
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The Tampa Scale for Kinesiophobia comprises 17 items on the fear of movement or recurrent lesion, each scored on a 4-point Likert scale from "completely disagree" to "completely agree".
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4 weeks
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Change from baseline Pressure pain thresholds (PPT) at one month
Time Frame: 4 weeks
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Examination of PPT will be performed with the use of an Algometer.
According to International Association for the Study of Pain, PPT is the smallest stimulus causing the feeling of pain (International Association for the Study of Pain, Subcommittee on Taxonomy, 1986).
The examination will carried out twice in the same places, on the left and right sides following the protocol described by Sipko et al.2013: musculus erector spinae - at the level of L2, 3 cm away from the interspinous line; musculus gluteus medius - between the greater trochanter and iliac crest sideways; musculus triceps surae - the transition of the belly of the muscle into the tendon; and musculus tibialis anterior - one-third of the upper shank, at the front.
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4 weeks
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Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month
Time Frame: 4 weeks
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The subject will be positioned in an erect sitting position on an examination plinth with the popliteal creases just off the edge of the plinth.
The subject will be asked to sit in a slouched position.
After, the subject will be asked to actively flex the cervical spine as far as comfortably possible.
After, the subject's ankle will be then passively dorsiflexed to slight resistance, while the knee is slowly passively extended.The knee will be extended until the subject reports onset of neural-mediated symptoms.The degree of knee extension will be measured with a large universal goniometer.
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4 weeks
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Change from baseline Mechanosensitive/straight-leg raise neurodynamic testing at one month
Time Frame: 4 weeks
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The subject will be positioned in supine with standardized head support.
After the test will be performed with the ankle in neutral position and with 30º of ankle flexion.
The hip will be flexed with the knee extended until the subject reports onset of neural-mediated symptoms.
The degree of hip flexion will be measured with a large universal goniometer.
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4 weeks
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Change from baseline Anxiety and depression measures at one month
Time Frame: 4 weeks
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Beck questionnaire
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4 weeks
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Change from baseline Quality of Sleep at one month
Time Frame: 4 weeks
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Pittsburgh questionnaire
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: María Encarnación Aguilar-Ferrándiz, Deparment of Physical Therapy. University of Granada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: Phys Ther. 2008 Jan;88(1):138-9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (ACTUAL)
April 1, 2018
Study Completion (ACTUAL)
April 1, 2018
Study Registration Dates
First Submitted
June 16, 2016
First Submitted That Met QC Criteria
June 23, 2016
First Posted (ESTIMATE)
June 24, 2016
Study Record Updates
Last Update Posted (ACTUAL)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 4, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELECBACK_KT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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