Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back
AECC
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
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 low-back-pain
Started Sep 2010
Shorter than P25 for phase_1 low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedAugust 12, 2010
June 1, 2010
6 months
July 30, 2010
August 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Pressure pain threshold over the spinous process
An average of 5 minutes from the end of the first treatment
Surface EMG (electromyography) of the lumbar erector spinae flexion-relaxation response
An average of 5 minutes from the end of treatment.
Study Arms (2)
Multiple thrust Impulse instrument
ACTIVE COMPARATORThis instrument automatically delivers 12 thrusts at the same intensity over the joint involved.
Single impulse Activator IV instrument
ACTIVE COMPARATORThis is a manual spring loaded device that delivers one thrust to the joint involved
Interventions
This is a manually operated device that delivers a single thrust into the joint involved.
A device used for delivering 12 thrusts to the involved joint of the lumbar spine.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Absolute contraindications to manipulation
- Specific causes for the low back pain
- Involved in or pending litigation for low back pain
- Lumbar related leg pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anglo-European College of Chiropractic
Bournemouth, Dorset, BH5 2DF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugh Gemmell, DC, EdD
Anglo-European College of Chiropractic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 12, 2010
Study Start
September 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
August 12, 2010
Record last verified: 2010-06