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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Anglo-European College of Chiropractic.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Anglo-European College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01180686
First received: July 30, 2010
Last updated: August 11, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Low Back Pain
Device: Activator IV single impulse instrument
Device: Multiple thrust Impulse adjusting instrument
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Anglo-European College of Chiropractic:

Primary Outcome Measures:
  • Correction of the spinal manipulable lesion [ Time Frame: An average of 5 minutes from the the end of first treatment ] [ Designated as safety issue: No ]
    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:
  • Pressure pain threshold over the spinous process [ Time Frame: An average of 5 minutes from the end of the first treatment ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Surface electromyography will be used pre-treatment and post-treatment to determine if a change in muscle activity occurs with flexing the lumbar spine.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180686

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

Locations
United Kingdom
Anglo-European College of Chiropractic Not yet recruiting
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
Principal Investigator: Hugh Gemmell, DC, EdD Anglo-European College of Chiropractic
  More Information

No publications provided

Responsible Party: Hugh Gemmell Principal Lecturer, Anglo-European College of Chiropractic
ClinicalTrials.gov Identifier: NCT01180686     History of Changes
Other Study ID Numbers: AECC 30610, AECC30610
Study First Received: July 30, 2010
Last Updated: August 11, 2010
Health Authority: United Kingdom: Department of Health

Keywords provided by Anglo-European College of Chiropractic:
low back pain
chiropractic
manipulation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014