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A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00922220
First received: June 15, 2009
Last updated: December 21, 2011
Last verified: June 2009
History of Changes

June 15, 2009
December 21, 2011
October 2004
November 2008   (final data collection date for primary outcome measure)
Numeric Rating Scale [ Time Frame: Prior to and immediately following assigned intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00922220 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain
Immediate Effect of Physical Interventions for Low Back Pain

The purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Back Pain
  • Other: stationary bike
    Participants rode a stationary bike for five minutes
  • Other: lumbar extension exercise
    Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes
    Other Name: press up
  • Other: spinal manipulative therapy
    participants received spinal manipulative therapy to the low back
    Other Names:
    • spinal manipulation
    • manual therapy
  • Active Comparator: stationary bike
    Participants rode a stationary bike for five minutes
    Intervention: Other: stationary bike
  • Active Comparator: lumbar extension exercises
    Participants performed four sets of fifteen lumbar extension exercises over five minutes
    Intervention: Other: lumbar extension exercise
  • Experimental: spinal manipulative therapy
    Participants received spinal manipulative therapy to the low back
    Intervention: Other: spinal manipulative therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ages eighteen to sixty
  • currently experiencing low back pain OR currently not experiencing low back pain and have not had an episode for the prior six months

Exclusion Criteria:

  • non-English speaking
  • systemic medical conditions (e.g. diabetes, hypertension)
  • current use of psychiatric medication
  • pregnancy
  • signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change)
  • history of surgery to the low back
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00922220
343-2004
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Steven Z George, Phd University of Florida Department of Physical Therapy
University of Florida
June 2009

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