Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effect of Manipulations of the Lumbar Spine on Six Different Outcome Measures

This study has been completed.
Information provided by:
Universite du Quebec a Montreal Identifier:
First received: August 20, 2008
Last updated: August 22, 2008
Last verified: August 2008
  1. Evaluation of the effect of a chiropractic adjustment (Manually Assisted Mechanical Force)on
  2. surface Static EMG
  3. Paraspinal cutaneous temperature
  4. Range of Motion
  5. Dynamic EMG
  6. Blood hormones (Interleukin-6 and C-Reactive protein)

Condition Intervention
Low Back Pain
Device: AAI signature IV AMCT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Manipulations of the Lumbar Spine on Six Different Outcome Measures.

Resource links provided by NLM:

Further study details as provided by Universite du Quebec a Montreal:

Primary Outcome Measures:
  • Oswestry Disability Index, Functional x-rays, Range of Motion, Static EMG, Dynamic EMG, Paraspinal cutaneous temperature, [ Time Frame: August 2008 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Active Comparator: 2
Activator chiropractic technique basic scan protocol
Device: AAI signature IV AMCT
Chiropractic adjustments of the lumbar spine following the activator basic scan protocol
Other Name: Activator adjusting instrument signature series version IV

  Show Detailed Description


Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


  • Written informed consent was obtained from all participants.

Control group

The inclusion criterion:

  • All participants were receiving maintenance chiropractic care
  • All participants would not have any treatment during the two week span of the research project
  • All participants were examined and x-rayed and were evaluated for all the same outcome measures.

Treatment group:

  • All participants were recruited via an announcement in the newspaper, Le Messager de LaSalle, during the period from July 6th to the 20th 2008.
  • The participants were suffering from a chronic low back condition of at least three months in duration.
  • All participants were examined and x-rayed and were evaluated for all the same outcome measures.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00739570

Canada, Quebec
Chiro-clinique Richard Roy
La Salle, Quebec, Canada, H8N 1X7
Sponsors and Collaborators
Universite du Quebec a Montreal
Principal Investigator: Richard A Roy, DCMScPhD(c) Universite du Quebec a Montreal
  More Information

No publications provided

Responsible Party: Dr. Richard Roy, UQAM Identifier: NCT00739570     History of Changes
Other Study ID Numbers: 071970
Study First Received: August 20, 2008
Last Updated: August 22, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Universite du Quebec a Montreal:

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on February 26, 2015