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OpenTrials
Completed

NCT Number: NCT00376350

Dose of Spinal Manipulation for Chronic Low Back Pain

This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current episode of low back pain
  • mechanical origin
  • Threshold low back pain level

Exclusion criteria

  • Contraindications to spinal manipulation or massage
  • Complicating conditions that could confound clinical outcome
  • Prophylactic use of prescription medication
  • Health-related litigation, claims, or disability compensation

Treatment and study plan

Spinal manipulation

Procedure

5 minutes high velocity, low amplitude lumbar thrust

Light Massage

Procedure

light pressure massage of the low back.

Pulsed Ultrasound

Procedure

5 minutes pulsed ultrasound

Primary outcomes

  1. Modified Von Korff Pain Scale for low back pain

    Time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

  2. Modified Von Korff Disability Scale

    Time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

Secondary outcomes

  1. Pain days

    Time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

  2. Disability days

    Time frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

  3. Low back pain unpleasantness

    Time frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks

  4. Fear avoidance beliefs

    Time frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks

  5. General health status/QoL

    Time frame: baseline 2; 12, 24, 39, 52 weeks

  6. Patient satisfaction

    Time frame: 12 wk

  7. Healthcare utilization

    Time frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks

  8. Objective measures

    Time frame: Baseline 2, 6 wk

  9. Bias monitoring

    Time frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks

Sponsors and collaborators

Lead sponsor

University of Western States

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Dose-Response/Efficacy of Manipulation for Chronic LBP

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2006
Registry last updated
Aug 24, 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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