Chiropractic Manipulation and Medical Care for Low Back Pain

Study Overview
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Brief Summary
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The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.

Official Title
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A Comparison of Chiropractic Manipulation Methods and Standard Medical Care for Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Manual Manipulation
* Device: Mechanically-assisted manipulation
* Other: Standard Medical Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥ 18 years of age Ability to read and write English Experiencing a new episode of low back pain (LBP) with onset in the past 3 months Oswestry Disability Index score between 20-70 points (0-100 scale) Numeric pain rating score between 3-8 points (0-10 scale) Exclusion Criteria: Prior history of lumbar spine surgery History of unstable spondylolisthesis, spinal stenosis, or scoliosis > 20° Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of >10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months) Receiving any on-going medical care for this episode of low back pain Current use of opiate or other prescription medications for low back pain

Ages Eligible for Study
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Minimum Age: 18 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: Manual Manipulation<br>Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. | Procedure: Manual Manipulation<br>* Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.<br>|
| Experimental: Mechanical Manipulation<br>Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument. | Device: Mechanically-assisted manipulation<br>* Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.<br>* Other names: Activator IV Instrument: FDA approval# K003185;|
| Active Comparator: Standard Medical Care<br>Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. | Other: Standard Medical Care<br>* Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Low Back Pain Disability Index | The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment). | 4 weeks (post treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Score. | Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating no pain and 10 indicating unbearable pain. Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment). | 4 weeks (post treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manipulation, Chiropractic, Low Back Pain