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

Phase 1

• Conditions: Low Back Pain
• Interventions: Device: Multiple thrust Impulse adjusting instrument; Device: Activator IV single impulse instrument

• Registration Number: NCT01180686
• Lead Sponsor: Anglo-European College of Chiropractic

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 Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-08-11
• Last Update Submitted: 2010-08-11
• Study First Posted: 2010-08-12
• Last Update Posted: 2010-08-12
• Study Start: 2010-09
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple thrust Impulse instrument	Multiple thrust Impulse adjusting instrument	This instrument automatically delivers 12 thrusts at the same intensity over the joint involved.
Single impulse Activator IV instrument	Activator IV single impulse instrument	This is a manual spring loaded device that delivers one thrust to the joint involved

Primary Outcome Measures

Name	Time	Method
Correction of the spinal manipulable lesion	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 Outcome Measures

Name	Time	Method
Pressure pain threshold over the spinous process	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	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.

Trial Locations

Locations (1)

Anglo-European College of Chiropractic; 🇬🇧 Bournemouth, Dorset, United Kingdom