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

Low Back Pain Clinical Trial

— AECC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01180686
• Other study ID #: AECC 30610
• Secondary ID: AECC30610
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 30, 2010
• Last updated: August 11, 2010
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2010
• Source: Anglo-European College of Chiropractic
• Contact: Hugh Gemmell, DC, EdD
• Phone: 44202436200
• Email: hgemmell[@]aecc.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Device:
• Activator IV single impulse instrument
This is a manually operated device that delivers a single thrust into the joint involved.
• Multiple thrust Impulse adjusting instrument
A device used for delivering 12 thrusts to the involved joint of the lumbar spine.

Locations

Country	Name	City	State
United Kingdom	Anglo-European College of Chiropractic	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Anglo-European College of Chiropractic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	No