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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Kinesio taping
Electrical Stimulation
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Electrical Stimulation Therapy, Kinesio taping, Exercise

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Adelaida Mª Castro Sánchez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesio taping plus exercise

Electrical stimulation plus exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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%).
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
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".
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.
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.
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.
Change from baseline Anxiety and depression measures at one month
Beck questionnaire
Change from baseline Quality of Sleep at one month
Pittsburgh questionnaire

Full Information

First Posted
June 16, 2016
Last Updated
October 4, 2018
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT02812459
Brief Title
Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Electrical Stimulation Therapy, Kinesio taping, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio taping plus exercise
Arm Type
Experimental
Arm Description
Kinesio taping application for low back plus back exercises.This protocol will be administered three a week for 4 weeks.
Arm Title
Electrical stimulation plus exercise
Arm Type
Active Comparator
Arm Description
Electrical stimulation for control pain applied in low back plus exercises.This protocol will be administered three a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Kinesio taping
Intervention Description
Kinesio taping is a new taping modality which act diminishing pain.
Intervention Type
Other
Intervention Name(s)
Electrical Stimulation
Intervention Description
Electrical stimulation therapy is a electrical current that allow patients diminish pain.
Primary Outcome Measure Information:
Title
Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month.
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Oswestry Disability Index (ODI) at one month.
Description
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%).
Time Frame
4 weeks
Title
Change from baseline Visual Analogue Scale (VAS) at one month
Description
The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain
Time Frame
4 weeks
Title
Change from baseline Tampa Scale for Kinesiophobia (TSK) at one month
Description
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".
Time Frame
4 weeks
Title
Change from baseline Pressure pain thresholds (PPT) at one month
Description
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.
Time Frame
4 weeks
Title
Change from baseline Mechanosensitive/the Seated Slump Test neurodynamic testing at one month
Description
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.
Time Frame
4 weeks
Title
Change from baseline Mechanosensitive/straight-leg raise neurodynamic testing at one month
Description
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.
Time Frame
4 weeks
Title
Change from baseline Anxiety and depression measures at one month
Description
Beck questionnaire
Time Frame
4 weeks
Title
Change from baseline Quality of Sleep at one month
Description
Pittsburgh questionnaire
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Encarnación Aguilar-Ferrándiz
Organizational Affiliation
Deparment of Physical Therapy. University of Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adelaida Mª Castro Sánchez
City
Almería
ZIP/Postal Code
S/N
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19881004
Citation
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Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain

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