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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168999
First received: July 22, 2010
Last updated: January 7, 2014
Last verified: November 2013

July 22, 2010
January 7, 2014
September 2009
January 2013   (final data collection date for primary outcome measure)
  • Believability of Placebo [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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".
  • believability of placebo [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    how helpful participants expect the assigned intervention will be in decreasing their low back pain
  • clinical pain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    oswestry functional questionnaire to measure functional limitations related to low back pain
  • pain sensitivity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    self report of pain resulting from standardized thermal and pressure pain stimuli
Complete list of historical versions of study NCT01168999 on ClinicalTrials.gov Archive Site
  • Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion [ Time Frame: Change from Baseline at 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
low back range of motion and strength [ Time Frame: 2 week ] [ Designated as safety issue: No ]
measures of low back range of motion and abdominal strength
Not Provided
Not Provided
 
The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Low Back Pain
  • Other: spinal manipulation
    a 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
    a sham spinal manipulation intended to mimic the studied spinal manipulation
  • 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"
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.
 
Completed
110
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01168999
345-2009
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Joel Bialosky, PT, PhD University of Florida
University of Florida
November 2013

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