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
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Correction of the spinal manipulable lesion
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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.)