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

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ClinicalTrials.gov Identifier: NCT02812459
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Encarnación Aguilar Ferrandiz, Universidad de Granada

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

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: Kinesio taping Other: Electrical Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month. [ Time Frame: 4 weeks ]
    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


Secondary Outcome Measures :
  1. Change from baseline Oswestry Disability Index (ODI) at one month. [ Time Frame: 4 weeks ]
    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%).

  2. Change from baseline Visual Analogue Scale (VAS) at one month [ Time Frame: 4 weeks ]
    The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain

  3. Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month [ Time Frame: 4 weeks ]
    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. Change from baseline Pressure pain thresholds (PPT) at one month [ Time Frame: 4 weeks ]
    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.

  5. Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month [ Time Frame: 4 weeks ]
    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.

  6. Change from baseline Mechanosensitive/straight-leg raise neurodynamic testing at one month [ Time Frame: 4 weeks ]
    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.

  7. Change from baseline Anxiety and depression measures at one month [ Time Frame: 4 weeks ]
    Beck questionnaire

  8. Change from baseline Quality of Sleep at one month [ Time Frame: 4 weeks ]
    Pittsburgh questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812459


Locations
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Spain
Adelaida Mª Castro Sánchez
Almería, Spain, S/N
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: María Encarnación Aguilar-Ferrándiz Deparment of Physical Therapy. University of Granada
Publications of Results:

Other Publications:
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Responsible Party: Encarnación Aguilar Ferrandiz, Lecturer, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02812459    
Other Study ID Numbers: ELECBACK_KT
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Keywords provided by Encarnación Aguilar Ferrandiz, Universidad de Granada:
Electrical Stimulation Therapy
Kinesio taping
Exercise
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations