The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- University of Florida
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 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".
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 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.
Secondary Outcomes
- Change From Baseline at 2 Weeks in Low Back Extension Range of Motion(Change from Baseline at 2 weeks)
- Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion(Change from Baseline at 2 weeks)
- Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion(Change from Baseline at 2 weeks)
- Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion(Change from Baseline at 2 weeks)