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

This study has been completed.
Sponsor:
Information provided by:
Universite du Quebec a Montreal
ClinicalTrials.gov Identifier:
NCT00739570
First received: August 20, 2008
Last updated: August 22, 2008
Last verified: August 2008
History of Changes
  Purpose
  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:

MedlinePlus related topics: Back Pain X-Rays
U.S. FDA Resources

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

  Eligibility

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

Inclusion Criteria:

Participants

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739570

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

No publications provided

Responsible Party: Dr. Richard Roy, UQAM
ClinicalTrials.gov 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:
Activator
EMG
Thermography
Diagnostic
X-Rays

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

ClinicalTrials.gov processed this record on May 16, 2013