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

• ClinicalTrials.gov Identifier: NCT01180686
• Recruitment Status: Unknown
• First Posted: August 12, 2010
• Last Update Posted: August 12, 2010
• Sponsor: Anglo-European College of Chiropractic
• Information provided by: Anglo-European College of Chiropractic

Tracking Information

• First Submitted Date: July 30, 2010
• First Posted Date: August 12, 2010
• Last Update Posted Date: August 12, 2010
• Study Start Date: September 2010
• Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back
• 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

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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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.
  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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 11, 2010): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2011
• Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01180686
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic
• Study Sponsor: Anglo-European College of Chiropractic
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hugh Gemmell, DC, EdD; Anglo-European College of Chiropractic

• PRS Account: Anglo-European College of Chiropractic
• Verification Date: June 2010