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Dose of Spinal Manipulation for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT00376350
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : August 24, 2015
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Mitchell Haas, University of Western States

Tracking Information
First Submitted Date  ICMJE September 12, 2006
First Posted Date  ICMJE September 14, 2006
Last Update Posted Date August 24, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • Modified Von Korff Pain Scale for low back pain [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ]
  • Modified Von Korff Disability Scale [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2006)
  • Modified Von Korff Pain Scale for low back pain
  • Modified Von Korff Disability Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • Pain days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ]
  • Disability days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ]
  • Low back pain unpleasantness [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ]
  • Fear avoidance beliefs [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ]
  • General health status/QoL [ Time Frame: baseline 2; 12, 24, 39, 52 weeks ]
  • Patient satisfaction [ Time Frame: 12 wk ]
  • Healthcare utilization [ Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks ]
  • Objective measures [ Time Frame: Baseline 2, 6 wk ]
  • Bias monitoring [ Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2006)
  • Pain days
  • Disability days
  • Low back pain unpleasantness
  • Fear avoidance beliefs
  • General health status/QoL
  • Patient satisfaction
  • Healthcare utilization
  • Objective measures
  • Bias monitoring
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose of Spinal Manipulation for Chronic Low Back Pain
Official Title  ICMJE Dose-Response/Efficacy of Manipulation for Chronic LBP
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Procedure: Spinal Manipulation
    5 minutes high velocity, low amplitude lumbar thrust
  • Procedure: Light Massage
    light pressure massage of the low back.
  • Procedure: Pulsed Ultrasound
    5 minutes pulsed ultrasound
Study Arms  ICMJE
  • Experimental: High dose manipulation
    High dose spinal manipulation + ultrasound
    Interventions:
    • Procedure: Spinal Manipulation
    • Procedure: Pulsed Ultrasound
  • Experimental: Moderate dose manipulation
    Moderate dose manipulation + low dose massage + ultrasound
    Interventions:
    • Procedure: Spinal Manipulation
    • Procedure: Light Massage
    • Procedure: Pulsed Ultrasound
  • Experimental: Low dose manipulation
    low dose spinal manipulation + moderate dose massage + ultrasound
    Interventions:
    • Procedure: Spinal Manipulation
    • Procedure: Light Massage
    • Procedure: Pulsed Ultrasound
  • High dose masssage
    high dose massage + ultrasound
    Interventions:
    • Procedure: Light Massage
    • Procedure: Pulsed Ultrasound
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2006)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00376350
Other Study ID Numbers  ICMJE U01AT001908( U.S. NIH Grant/Contract )
U01AT001908 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitchell Haas, University of Western States
Study Sponsor  ICMJE University of Western States
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Mitchell Haas, DC, MA University of Western States
PRS Account University of Western States
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP