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Completed

NCT Number: NCT01866332

Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain

The purpose of this study is to determine the effectiveness of the addition of the use of Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional physical therapy.

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Key information

Conditions

Nonspecific Chronic Low Back Pain Back Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Outpatient Department

São Paulo, 03071000, Brazil

About this study

One hundred and forty-eight patients will be randomized to receive either conventional physical therapy, which consist of a combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization (Conventional Physical Therapy Group) or to receive conventional physical therapy plus the addition of the Kinesio Taping in the lumbar spine (Conventional Physical Therapy plus Kinesio Taping), over a period of 5 weeks (10 sessions of treatment).

Clinical outcomes (pain intensity, disability and global perceived effect ) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. Data will be collected by a blinded examiner who will be unaware about the group allocation. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with non-specific low back pain longer than 12 weeks
  • Seeking care for low back pain

Exclusion criteria

  • Contra indications to physical exercise
  • Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
  • Nerve root compromise
  • Contra indications to the Kinesio Taping (e.g. intolerance to tapes, band aids etc)
  • Pregnancy
  • Severe cardiorespiratory conditions

Treatment and study plan

Conventional physical therapy

Other

Combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). The treatment will be tailored to the patient presentation (i.e. pragmatic treatment).

Other names: Manual therapy, Exercise therapy, Specific exercises

Kinesio Tex Gold ( Kinesiotaping )

Device

Kinesiotaping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the superficial back muscles (erector spinae muscles).

Other names: Bandages, Tape, Taping, Kinesio Tex, Kinesio Tape, Kinesiotape

Primary outcomes

  1. Pain Intensity

    Time frame: Five weeks after randomization

    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability

    Time frame: Five weeks after randomization

    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire

Secondary outcomes

  1. Pain Intensity

    Time frame: 3 and 6 months after randomization

    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability

    Time frame: 3 and 6 months after randomization

    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire

  3. Global impression of recovery

    Time frame: 5 weeks, 3 and 6 months after randomization

    Global impression of recovery will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Other outcomes

  1. Satisfaction with care

    Time frame: 5 weeks after randomization

    Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Registry information

Official study title

Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 31, 2013
Registry last updated
Jan 15, 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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