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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

Tracking Information
First Submitted Date  ICMJE July 30, 2010
First Posted Date  ICMJE August 12, 2010
Last Update Posted Date August 12, 2010
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Multiple thrust Impulse instrument
    This instrument automatically delivers 12 thrusts at the same intensity over the joint involved.
    Intervention: Device: Multiple thrust 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
    Intervention: Device: Activator IV single impulse instrument
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01180686
Other Study ID Numbers  ICMJE AECC 30610
AECC30610 ( Other Identifier: Anglo-European College of Chiropractic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic
Study Sponsor  ICMJE Anglo-European College of Chiropractic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hugh Gemmell, DC, EdD Anglo-European College of Chiropractic
PRS Account Anglo-European College of Chiropractic
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP