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

Chronic Low Back Pain Clinical Trial

— ELECBACK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812459
• Other study ID #: ELECBACK_KT
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 2018

Study information

• Verified date: October 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Kinesio taping
Kinesio taping is a new taping modality which act diminishing pain.
• Electrical Stimulation
Electrical stimulation therapy is a electrical current that allow patients diminish pain.

Locations

Country	Name	City	State
Spain	Adelaida Mª Castro Sánchez	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (21)

Added MA, Costa LO, de Freitas DG, Fukuda TY, Monteiro RL, Salomão 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 — View Citation

Álvarez-Álvarez S, José FG, Rodríguez-Fernández AL, Güeita-Rodríguez J, Waller BJ. Effects of Kinesio® Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects. J Back Musculoskelet Rehabil. 2014;27(2):20 — View 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. — View 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. — View Citation

Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. Review. — View 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. — View 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. — View 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. 20 — View Citation

Frahm KS, Hennings K, Vera-Portocarrero L, Wacnik PW, Mørch 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: 10.111 — View 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. Erratum in: Phys Ther. 2008 Jan;88(1):138-9. — View 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):10 — View 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: 10.2 — View 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/ — View 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):898-90 — View 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. Review. — View 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 — View Citation

Kelle B, Güzel 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. Epub 2015 Aug 27. — View Citation

Luz Júnior MA, Sousa MV, Neves LA, Cezar AA, Costa LO. Kinesio Taping® 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- — View Citation

Melloh M, Elfering A, Stanton TR, Käser A, Salathé CR, Barz T, Röder 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. — View 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. — View 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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline Oswestry Disability Index (ODI) at one month.	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%).	4 weeks
Secondary	Change from baseline Visual Analogue Scale (VAS) at one month	The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain	4 weeks
Secondary	Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month	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".	4 weeks
Secondary	Change from baseline Pressure pain thresholds (PPT) at one month	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.	4 weeks
Secondary	Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month	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.	4 weeks
Secondary	Change from baseline Mechanosensitive/straight-leg raise neurodynamic testing at one month	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.	4 weeks
Secondary	Change from baseline Anxiety and depression measures at one month	Beck questionnaire	4 weeks
Secondary	Change from baseline Quality of Sleep at one month	Pittsburgh questionnaire	4 weeks