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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
  Purpose

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).


Condition Intervention Phase
Low Back Pain
 Other: stationary bike
Other: lumbar extension exercise
Other: spinal manipulative therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immediate Effect of Physical Interventions for Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Numeric Rating Scale [ Time Frame: Prior to and immediately following assigned intervention ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: October 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: stationary bike
Participants rode a stationary bike for five minutes
 Other: stationary bike
Participants rode a stationary bike for five minutes
Active Comparator: lumbar extension exercises
Participants performed four sets of fifteen lumbar extension exercises over five minutes
 Other: lumbar extension exercise
Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes
Other Name: press up
Experimental: spinal manipulative therapy
Participants received spinal manipulative therapy to the low back
 Other: spinal manipulative therapy
participants received spinal manipulative therapy to the low back
Other Names:
  • spinal manipulation
  • manual therapy

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922220

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Steven Z George, Phd University of Florida Department of Physical Therapy
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00922220     History of Changes
Other Study ID Numbers: 343-2004
Study First Received: June 15, 2009
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
low back pain
spinal manipulation
central sensitization
manual therapy

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