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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
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 intended to mimic the studied 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"
University of Florida
Gainesville, Florida, United States
Believability of Placebo
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
Time frame: baseline
Expectation for Treatment Effectiveness
how helpful participants expect the assigned intervention will be in decreasing their low back pain
Time frame: baseline
Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Time frame: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
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.
Time frame: Change from Baseline at 2 weeks
Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
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".
Time frame: baseline and immediately following their assigned intervention during the initial session
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Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
Low back flexion range of motion was measured in degrees using a gravity inclinometer
Time frame: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
Low back extension range of motion was measured in degrees using a gravity inclinometer
Time frame: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
Low back right sidebending range of motion was measured in degrees using a gravity inclinometer
Time frame: Change from Baseline at 2 weeks
Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
Time frame: Change from Baseline at 2 weeks