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

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: spinal manipulation
* Other: sham spinal manipulation
* Other: Enhanced sham spinal manipulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: spinal manipulation<br>a spinal manipulation known to be effective in the treatment of low back pain for some individuals | Other: spinal manipulation<br>* Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain<br>|
| Placebo Comparator: sham spinal manipulation<br>a sham spinal manipulation intended to mimic the studied spinal manipulation | Other: sham spinal manipulation<br>* Sham spinal manipulation intended to mimic the studied spinal manipulation<br>|
| No Intervention: natural history<br>No intervention is provided to participants in this arm of the study | |
| Placebo Comparator: Enhanced sham spinal manipulation<br>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 | Other: Enhanced sham spinal manipulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline | 
| Expectation for Treatment Effectiveness | how helpful participants expect the assigned intervention will be in decreasing their low back pain | 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 | 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. | 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. | baseline and immediately following their assigned intervention during the initial session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Change from Baseline at 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, spinal manipulation, manual therapy, placebo