Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back

Study Overview
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Brief Summary
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The purposes of this study are to determine if there is a difference between two treatment methods of spine joints that are not moving as they should as determined by tenderness over the spine and activity of the muscles along side the spine with movement. The hypothesis is that there will be no difference between the two types of treatment.

Detailed Description
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Two specialised instruments used for treating manipulable lesions of the spine will be compared using muscle relaxation response of the erector spinae muscles and correction of the spinal manipulable lesion.

Official Title
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Comparative Effectiveness of the Multiple Thrust Impulse Instrument and the Activator IV Single Thrust Instrument in Correcting a Lumbar Spinal Manipulable Lesion and Improving Lumbar Erector Spinae Flexion-relaxation

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Activator IV single impulse instrument
* Device: Multiple thrust Impulse adjusting instrument


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18-64 years of age Fluent in English With non-specific low back pain No lumbar manipulation within the prior 24 hours Not involved in strenuous back exercise on the day preceding the study Have not taken pain medication for two days prior to the study Exclusion Criteria: Absolute contraindications to manipulation Specific causes for the low back pain Involved in or pending litigation for low back pain Lumbar related leg pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Multiple thrust Impulse instrument<br>This instrument automatically delivers 12 thrusts at the same intensity over the joint involved. | Device: Multiple thrust Impulse adjusting instrument<br>* A device used for delivering 12 thrusts to the involved joint of the lumbar spine.<br>* Other names: Impulse adjusting instrument;|
| Active Comparator: Single impulse Activator IV instrument<br>This is a manual spring loaded device that delivers one thrust to the joint involved | Device: Activator IV single impulse instrument<br>* This is a manually operated device that delivers a single thrust into the joint involved.<br>* Other names: Activator IV instrument;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correction of the spinal manipulable lesion | Tests used to determine the presence of a spinal manipulable lesion (a lesion in the spine requiring manipulation) will be used post-treatment to determine of correction has been achieved. | An average of 5 minutes from the the end of first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold over the spinous process | An instrument used to measure pressure in kilograms is placed over the spinous process of the vertebra involved and the level of pressure is recorded when the sensation of pressure changes to pain. | An average of 5 minutes from the end of the first treatment | 
| Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response | Surface electromyography will be used pre-treatment and post-treatment to determine if a change in muscle activity occurs with flexing the lumbar spine. | An average of 5 minutes from the end of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, chiropractic, manipulation