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

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ClinicalTrials.gov Identifier: NCT01180686
Recruitment Status : Unknown
Verified June 2010 by Anglo-European College of Chiropractic.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2010
Last Update Posted : August 12, 2010
Sponsor:
Information provided by:
Anglo-European College of Chiropractic

Study Description
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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.


Condition or disease Intervention/treatment Phase
Low Back Pain Device: Activator IV single impulse instrument Device: Multiple thrust Impulse adjusting instrument Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : September 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180686


Contacts
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Contact: Hugh Gemmell, DC, EdD 44202436200 ext 268 hgemmell@aecc.ac.uk

Locations
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United Kingdom
Anglo-European College of Chiropractic
Bournemouth, Dorset, United Kingdom, BH5 2DF
Contact: Hugh Gemmell, DC, EdD       hgemmell@aecc.ac.uk   
Principal Investigator: Hugh Gemmell, DC, EdD         
Sponsors and Collaborators
Anglo-European College of Chiropractic
Investigators
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Principal Investigator: Hugh Gemmell, DC, EdD Anglo-European College of Chiropractic
More Information
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Responsible Party: Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic
ClinicalTrials.gov Identifier: NCT01180686    
Other Study ID Numbers: AECC 30610
AECC30610 ( Other Identifier: Anglo-European College of Chiropractic )
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: June 2010
Keywords provided by Anglo-European College of Chiropractic:
low back pain
chiropractic
manipulation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations