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Completed

NCT Number: NCT02812459

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

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

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Key information

Conditions

Chronic Low Back Pain Behavior Motor Activity

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adelaida Mª Castro Sánchez

Almería, S/N, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kinesio Taping

Other

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

Electrical Stimulation

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Short-term Effectiveness of Additional Electrical Stimulation to Exercise Versus Kinesio Taping in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

Acronym: ELECBACK

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2016
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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