Kinesio Taping Efficacy in Chronic Low Back Pain Treatment (KITALO)

NCT02604290 | Completed

• 1 other identifier: MSK063
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the kinesio taping method is effective in the treatment of chronic (more than six months duration) low back pain.

Conditions

Chronic Low Back Pain

Keywords

Kinesio taping; Neuromuscular taping; Targeted treatment; Chronic low back pain; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in "Roland Morris Disability Questionnaire"

  Assess activity limitations due to back pain. Consists of 24 statements. Patients were asked to answer yes or no to each statement. Each positive answer is worth one point with scores ranging from 0 (no disability) to 24 (severely disabled). The Spanish version has been validated.

  pretreatment, 4 weeks, 6 month

Secondary Outcomes (3)

• Change in "Fear Avoidance Beliefs Questionnaire"

  pretreatment, 4 weeks, 6 month

• Change in "Pain Catastrophizing Scale"

  pretreatment, 4 weeks, 6 month

• Change in "Hospital Anxiety and Depression subscale"

  pretreatment, 4 weeks, 6 month

Other Outcomes (4)

• Charlson Comorbidity Index

  pretreatment

• Adverse effects

  4 weeks

• Change in "EuroQol-5D-5L (EuroQol 5 dimensions and 5 levels)"

  pretreatment, 4 weeks, 6 month

Study Arms (2)

Kinesio Taping method

EXPERIMENTAL

The tape is applied depending on the physical examination: * Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively. * Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point. * Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers.

Device: Kinesio Taping method

Kinesio Taping sham

SHAM COMPARATOR

The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position.

Device: Kinesio Taping sham

Interventions

Kinesio Taping method DEVICE

The tape is applied depending on the physical examination: * Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively. * Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point. * Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers.

Kinesio Taping method

Kinesio Taping sham DEVICE

The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position.

Kinesio Taping sham

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years.
• Chronic low back pain least 6 months duration.
• Improvement of pain with mobilization of skin/fascias in physical examination.
• Signature of informed consent.

You may not qualify if:

• Having had previous treatment experience with kinesio taping method.
• Presence of components of neuropathic pain (radiculopathy, lumbar canal stenosis).
• Specific origin pain (vertebral fracture, tumor or nerve column structures, spondyloarthropathy, spondylodiscitis).
• Prior spine surgery.
• Mental retardation, severe mental illness, substance abuse or dependency, illiteracy.

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead
• Cardenal Herrera University: collaborator
• Hospital Arnau de Vilanova: collaborator

Study Sites (1)

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Related Publications (6)

• Kent P, Mjosund HL, Petersen DH. Does targeting manual therapy and/or exercise improve patient outcomes in nonspecific low back pain? A systematic review. BMC Med. 2010 Apr 8;8:22. doi: 10.1186/1741-7015-8-22.

  PMID: 20377854 BACKGROUND

• Parreira Pdo C, Costa Lda C, Hespanhol LC Jr, Lopes AD, Costa LO. Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. J Physiother. 2014 Mar;60(1):31-9. doi: 10.1016/j.jphys.2013.12.008. Epub 2014 Apr 24.

  PMID: 24856938 BACKGROUND

• Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24.

  PMID: 21430611 BACKGROUND

• Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7.

  PMID: 22613238 BACKGROUND

• 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 BACKGROUND

• Parreira Pdo C, Costa Lda C, Takahashi R, Hespanhol Junior LC, Luz Junior MA, Silva TM, Costa LO. Kinesio taping to generate skin convolutions is not better than sham taping for people with chronic non-speci fi c low back pain: a randomised trial. J Physiother. 2014 Jun;60(2):90-6. doi: 10.1016/j.jphys.2014.05.003. Epub 2014 Jun 10.

  PMID: 24952836 BACKGROUND

Study Officials

• María Lourdes Peñalver Barrios, MD

  Hospital Arnau de Vilanova, Valencia, Spain

  PRINCIPAL INVESTIGATOR

• Julio Domenech Fernández, MD, PhD

  Hospital Arnau de Vilanova, Valencia, Spain

  STUDY DIRECTOR

• Juan Francisco Lisón Párraga, MD, PhD

  Cardenal Herrera CEU University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-PhD

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 13, 2015
• Study Start: December 15, 2015
• Primary Completion: September 15, 2016
• Study Completion: November 14, 2016
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

ES (1)