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The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01168999
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : December 23, 2013
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE July 22, 2010
First Posted Date  ICMJE July 23, 2010
Results First Submitted Date  ICMJE May 10, 2013
Results First Posted Date  ICMJE December 23, 2013
Last Update Posted Date October 28, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • Believability of Placebo [ Time Frame: baseline ]
    Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT
  • Expectation for Treatment Effectiveness [ Time Frame: baseline ]
    how helpful participants expect the assigned intervention will be in decreasing their low back pain
  • Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale [ Time Frame: Change from Baseline at 2 weeks ]
    A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
  • Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index [ Time Frame: Change from Baseline at 2 weeks ]
    The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
  • Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale [ Time Frame: baseline and immediately following their assigned intervention during the initial session ]
    Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating "no pain at all" and 100 mm indicating "the worst pain imaginable".
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
  • believability of placebo [ Time Frame: 2 weeks ]
    assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo
  • expectation for treatment effectiveness [ Time Frame: 2 weeks ]
    how helpful participants expect the assigned intervention will be in decreasing their low back pain
  • clinical pain [ Time Frame: 2 weeks ]
    A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
  • disability [ Time Frame: 2 weeks ]
    oswestry functional questionnaire to measure functional limitations related to low back pain
  • pain sensitivity [ Time Frame: 2 weeks ]
    self report of pain resulting from standardized thermal and pressure pain stimuli
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]
    Low back flexion range of motion was measured in degrees using a gravity inclinometer
  • Change From Baseline at 2 Weeks in Low Back Extension Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]
    Low back extension range of motion was measured in degrees using a gravity inclinometer
  • Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]
    Low back right sidebending range of motion was measured in degrees using a gravity inclinometer
  • Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]
    Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
low back range of motion and strength [ Time Frame: 2 week ]
measures of low back range of motion and abdominal strength
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Official Title  ICMJE The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Brief Summary The purpose of this study is to determine whether a novel placebo for comparison to spinal manipulation is believable and creates similar expectation for treatment effectiveness as the studied spinal manipulation technique. Additionally, we wish to compare outcomes related to low back pain, function, and pain sensitivity between people receiving the placebo, spinal manipulation, and no therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Other: spinal manipulation
    Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain
  • Other: sham spinal manipulation
    Sham spinal manipulation intended to mimic the studied spinal manipulation
  • Other: Enhanced sham spinal manipulation
    Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
Study Arms  ICMJE
  • Active Comparator: spinal manipulation
    a spinal manipulation known to be effective in the treatment of low back pain for some individuals
    Intervention: Other: spinal manipulation
  • Placebo Comparator: sham spinal manipulation
    a sham spinal manipulation intended to mimic the studied spinal manipulation
    Intervention: Other: sham spinal manipulation
  • No Intervention: natural history
    No intervention is provided to participants in this arm of the study
  • Placebo Comparator: Enhanced sham spinal manipulation
    a sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
    Intervention: Other: Enhanced sham spinal manipulation
Publications * Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.

*   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: November 4, 2013)
110
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2010)
88
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • currently experiencing low back pain which does not extend below the knees
  • rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
  • appropriate for conservative management of low back pain
  • english speaking

Exclusion Criteria:

  • surgery to the low back over the past 6 months
  • systemic disease known to effect sensation
  • other chronic pain condition unrelated to low back pain
  • fracture as a cause of low back pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (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 NCT01168999
Other Study ID Numbers  ICMJE 345-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Florida
Original Responsible Party Joel E Bialosky, PT, PhD, University of Florida
Current Study Sponsor  ICMJE University of Florida
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel Bialosky, PT, PhD University of Florida
PRS Account University of Florida
Verification Date October 2015

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