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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Other: Kinesio taping; Other: Electrical Stimulation

• Registration Number: NCT02812459
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kinesio taping plus exercise	Kinesio taping	Kinesio taping application for low back plus back exercises.This protocol will be administered three a week for 4 weeks.
Electrical stimulation plus exercise	Electrical Stimulation	Electrical stimulation for control pain applied in low back plus exercises.This protocol will be administered three a week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Roland Morris Disability Questionnaire (RMDQ) at one month.	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

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

Trial Locations

Locations (1)

Adelaida Mª Castro Sánchez; 🇪🇸 Almería, Spain