Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back (AECC)
Recruitment status was: Not yet recruiting
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.
|Low Back Pain||Device: Activator IV single impulse instrument Device: Multiple thrust Impulse adjusting instrument||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Correction of the spinal manipulable lesion [ Time Frame: An average of 5 minutes from the the end of first treatment ]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.
- Pressure pain threshold over the spinous process [ Time Frame: An average of 5 minutes from the end of the first treatment ]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.
- Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response [ Time Frame: An average of 5 minutes from the end of treatment. ]Surface electromyography will be used pre-treatment and post-treatment to determine if a change in muscle activity occurs with flexing the lumbar spine.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Multiple thrust Impulse instrument
This instrument automatically delivers 12 thrusts at the same intensity over the joint involved.
Device: Multiple thrust Impulse adjusting instrument
A device used for delivering 12 thrusts to the involved joint of the lumbar spine.
Other Name: Impulse adjusting instrument
Active Comparator: Single impulse Activator IV instrument
This is a manual spring loaded device that delivers one thrust to the joint involved
Device: Activator IV single impulse instrument
This is a manually operated device that delivers a single thrust into the joint involved.
Other Name: Activator IV instrument
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180686
|Contact: Hugh Gemmell, DC, EdD||44202436200 ext firstname.lastname@example.org|
|Anglo-European College of Chiropractic||Not yet recruiting|
|Bournemouth, Dorset, United Kingdom, BH5 2DF|
|Contact: Hugh Gemmell, DC, EdD email@example.com|
|Principal Investigator: Hugh Gemmell, DC, EdD|
|Principal Investigator:||Hugh Gemmell, DC, EdD||Anglo-European College of Chiropractic|