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Completed

NCT Number: NCT02067494

Myofascial Release and Kinesio Taping on Autonomic Nervous System in Low Back Pain

The purpose of this current randomized clinical trial is to determine the effects of myofascial soft tissue release and kinesio taping on disability, pain, quality of life, autonomic nervous system and oxidative stress indicators in chronic low back pain.

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Key information

Conditions

Low Back Pain Back Pain Chronic Disease Chronic Pain Disease Attributes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Almeria

Almería, 04120, Spain

About this study

Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft tissue release and kinesio taping on pain, disability, quality of life, and autonomic nervous system indicators.

Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

Intervention: For 10-week, the group 1 will undergo treatment comprising a myofascial soft tissue release protocol (1/week) and the group 2 will recieve a kinesio taping treatment (1/week).

Main Outcome Measures: Intensity of pain, disability, quality of life, biochemical stimation intertitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nevous system, and indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15 weeks after the last intervention. Baseline demographic and clinical variables will be examined between both groups with an independent Student t-test for continuous data. Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the within-subjects factor, group will be to determine the effects of the treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Score ≥ 4 on the Roland Morris Disability Questionnaire.
  • Low Back Pain for ≥ 3 months.
  • Not undergoing another physical therapy treatment.

Exclusion criteria

  • Disease of the central or peripheral nervous system.
  • Having previously undergone manual therapy.
  • Contraindication to low back manual therapy.
  • A history of spinal surgery.
  • Treatment with corticosteroid in the past two weeks.
  • Clinical sign of radiculopathy
  • Presence of Stenosis

Treatment and study plan

Myofascial Soft Tissue Release

Other

Protocol: Myofascial release on thoracolumbar fascia, Myofascial release on diaphragm, Myofascial release in the psoas fascia, Indirect Myofascial release restrictions in the public area, Myofascial release in lumbo-sacral decompression, Myofascial release on sacrum, and Myofascial release on the lumbar fascia.

Kinesio Taping treatment

Other

Two bands in "I", with anchor onset in sacrum, on paravertebral muscles. Furthermore a strip will be applies on correction space point of maximum pain.

Primary outcomes

  1. Change from baseline in Roland Morris Disability Questionnaire (RMDQ)

    Time frame: At baseline, 10 weeks and 15 weeks

    This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities

Secondary outcomes

  1. Change form baseline in Visual Analogue Scale

    Time frame: At baseline, 10 weeks and 15 weeks

    A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.

  2. Change from baseline in Lifestyle Indicators

    Time frame: At baseline, 10 weeks and 15 weeks

    Estimation of interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress.

  3. Change from baseline on Neural Network Analysis

    Time frame: At baseline, 10 weeks and 15 weeks

    Analysis of the projection on the spine and segmental innervation projection.

  4. Change from baseline on Quality of Life

    Time frame: At baseline, 10 weeks and 15 weeks

    SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Myofascial Release and Kinesiotaping on Disability, Pain, Automic Nervous System and Oxidative Stress Indicators in Chronic Low Back Pain: A Randomized Controlled Clinical Trial

Acronym: I

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2014
Registry last updated
Mar 5, 2015

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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