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

This study is currently recruiting participants.
Verified by University of Florida, July 2010
First Received: July 22, 2010 No Changes Posted

Sponsor:
University of Florida
Information provided by:
University of Florida
ClinicalTrials.gov Identifier:
NCT01168999

Purpose
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.

Condition Intervention Phase
Low Back Pain Other: spinal manipulation
Other: sham spinal manipulation
Other: natural history
Phase I
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Active Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

Further study details as provided by University of Florida:
Primary Outcome Measures:

  • 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 Secondary Outcome Measures:
  • 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
Estimated Enrollment: 88
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
 
Arms Assigned Interventions
spinal manipulation: Active Comparator
a spinal manipulation known to be effective in the treatment of low back pain for some individuals Intervention: Other: spinal manipulation
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
sham spinal manipulation: Placebo Comparator
a sham spinal manipulation intended to mimic the studied spinal manipulation Intervention: Other: sham spinal manipulation
Other: sham spinal manipulation
a sham spinal manipulation intended to mimic the studied spinal manipulation

natural history: No Intervention
No intervention is provided to participants in this arm of the study Intervention: Other: natural history

Other: natural history
Participants in this arm of the study receive no treatment


Eligibility
Ages Eligible for Study: 18 Years to 60 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
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
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