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Completed

NCT Number: NCT01919268

Addition of the Interferential Current to the Pilates Method in the Treatment of Chronic Nonspecific Low Back Pain

This study aims to evaluate the effectiveness of the addition of the interferential current to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low back pain.

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Key information

Conditions

Chronic Nonspecific Low Back Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Outpatient Department

São Paulo, 03071000, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sedentary patients with chronic nonspecific low back pain longer than 12 weeks
  • Pain greater than three points in Pain Numerical Rating Scale

Exclusion criteria

  • Contra indications to physical exercise
  • Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
  • Nerve root compromise
  • Pregnancy
  • Infection and/or skin lesions at the site of the application of the interferential current
  • Cancer
  • Cardiac pacemaker
  • Changes in sensitivity or allergy in the region of electrode placement
  • Previous surgery on spine or physical therapy for chronic nonspecific low back pain in the last six months
  • Previous experience with the Pilates method

Treatment and study plan

Electrotherapy

Device

Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of Pilates method will be individualized to each patient's needs (pragmatic treatment).

Pilates

Device

Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).

Primary outcomes

  1. Disability

    Time frame: Six weeks after randomization

    Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire

  2. Pressure pain threshold

    Time frame: Six weeks after randomization

    Pressure pain threshold will be evaluated using a pressure algometer

  3. Pain intensity

    Time frame: Six weeks after randomization

    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

Secondary outcomes

  1. Pain intensity

    Time frame: Six months after randomization

    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Disability

    Time frame: Six months after randomization

    Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire

  3. Global impression of recovery

    Time frame: Six weeks and six months after randomization

    Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale

  4. Specific disability

    Time frame: Six weeks and six months after randomization

    Specific disability will be evaluated by an 11-point Patient-specific Functional Scale

  5. Kinesiophobia

    Time frame: Six weeks and six months after randomization

    Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Registry information

Official study title

Effectiveness of the Addition of the Interferential Current to the Pilates Method in the Treatment of Patients With Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 8, 2013
Registry last updated
Jun 16, 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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