Central Mechanism of Manual Therapy for Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to examine the change of nervous system activity before and after spinal manipulation treatment program in people with low back pain.

Official Title
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Central Mechanism of Manual Therapy for Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Spinal Manipulation
* Other: Placebo Spinal Manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of subacute low back pain Ability to read and understand English Exclusion Criteria: Previous low back surgery Severe structural spinal deformity Neurological compromise resulting in current nerve root entrapment Spinal cord compression Tumor Severe spinal instability Severe osteoporosis Psychiatric disease Head trauma Spinal infection Known cardiovascular or metabolic disease Known neurological, neuromuscular or orthopedic problems that might prevent them from participating in manual therapy interventions Pregnancy Mini-Mental State Examination score < 25 Body Mass Index (BMI) < 18 or > 30 Pain or paresthesia below the knees Systemic illness known to affect sensation i.e. diabetes Acute and/or chronic pain condition unrelated to LBP

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 |
| --- | --- |
| Experimental: Spinal Manipulation<br>Subjects with subacute low back pain. Subjects will receive 6 treatments of Spinal Manipulation (SM) over 2 consecutive weeks | Other: Spinal Manipulation<br>* The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.<br>|
| Placebo Comparator: Placebo Spinal Manipulation<br>Subjects with subacute low back pain. Subjects will be asked to visit the clinic for 6 times. The clinician will go through SM motions but the spine will not actually be manipulated. | Other: Placebo Spinal Manipulation<br>* The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Threshold measured using Pain Pressure Threshold (PPT) testing | Outcome will be measured using Pain Pressure Threshold (PPT) testing. Pressure will be applied to subjects using a digital algometer. Three trials for PPT will be done and the mean value will be calculated. | Change from Pre-treatment to Post-treatment, 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in function measured using the Oswestry Disability Index (ODI) | Outcome will be measured using the Oswestry Disability Index (ODI). Subjects answer to questions. Their responses indicate no impact to great impact. Scores for each question range from 0 to 5. Total score for the ODI is 50. The higher the score, the greater level of disability/function. | Change from Baseline to Week 2 | 
| Change in Low Back Pain measured using the Numerical Pain Rating Scale (NPRS) | Outcome will be measured using the Numerical Pain Rating Scale (NPRS). Pain intensity will be assessed using an 11-point scale. Scores on the scale range from 0 indicating no pain, 1 slight pain, and 10 strongest imaginable pain. | Change from Baseline to Week 2 | 
| Change in Fear Avoidance Beliefs Questionnaire (FABQ) | The FABQ is completed by the subject. It determines the level of fear and avoidance about work and physical activity. The measure is comprised of two subscales: a four item physical activity subscale (FABQ-W), and a seven-item work subscale (FABQ-W). An elevated FABQ score is predictive of the development of chronic disability in low back pain (LBP) patients. | Change from Baseline to Week 2 |