Dose of Spinal Manipulation for Chronic Low Back Pain

Study Overview
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Brief Summary
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This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.

Official Title
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Dose-Response/Efficacy of Manipulation for Chronic LBP

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Spinal Manipulation
* Procedure: Light Massage
* Procedure: Pulsed Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current episode of low back pain mechanical origin Threshold low back pain level Exclusion Criteria: Contraindications to spinal manipulation or massage Complicating conditions that could confound clinical outcome Prophylactic use of prescription medication Health-related litigation, claims, or disability compensation

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose manipulation<br>High dose spinal manipulation + ultrasound | Procedure: Spinal Manipulation<br>* 5 minutes high velocity, low amplitude lumbar thrust<br>Procedure: Pulsed Ultrasound<br>* 5 minutes pulsed ultrasound<br>|
| Experimental: Moderate dose manipulation<br>Moderate dose manipulation + low dose massage + ultrasound | Procedure: Spinal Manipulation<br>* 5 minutes high velocity, low amplitude lumbar thrust<br>Procedure: Light Massage<br>* light pressure massage of the low back.<br>Procedure: Pulsed Ultrasound<br>* 5 minutes pulsed ultrasound<br>|
| Experimental: Low dose manipulation<br>low dose spinal manipulation + moderate dose massage + ultrasound | Procedure: Spinal Manipulation<br>* 5 minutes high velocity, low amplitude lumbar thrust<br>Procedure: Light Massage<br>* light pressure massage of the low back.<br>Procedure: Pulsed Ultrasound<br>* 5 minutes pulsed ultrasound<br>|
| Other: High dose masssage<br>high dose massage + ultrasound | Procedure: Light Massage<br>* light pressure massage of the low back.<br>Procedure: Pulsed Ultrasound<br>* 5 minutes pulsed ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Von Korff Pain Scale for low back pain |  | baseline 1&2, 6, 12, 18, 24, 39, 52 weeks | 
| Modified Von Korff Disability Scale |  | baseline 1&2, 6, 12, 18, 24, 39, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain days |  | baseline 1&2, 6, 12, 18, 24, 39, 52 weeks | 
| Disability days |  | baseline 1&2, 6, 12, 18, 24, 39, 52 weeks | 
| Low back pain unpleasantness |  | baseline 2, 6, 12, 18, 24, 39, 52 weeks | 
| Fear avoidance beliefs |  | baseline 2, 6, 12, 18, 24, 39, 52 weeks | 
| General health status/QoL |  | baseline 2; 12, 24, 39, 52 weeks | 
| Patient satisfaction |  | 12 wk | 
| Healthcare utilization |  | baseline 2; 6, 12, 18, 24, 39, 52 weeks | 
| Objective measures |  | Baseline 2, 6 wk | 
| Bias monitoring |  | baseline 1&2; 6, 12, 18, 24, 39, 52 weeks | 

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