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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:
ClinicalTrials.gov Identifier:
NCT00922220
First Posted: June 17, 2009
Last Update Posted: December 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Effect of Physical Interventions for Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Numeric Rating Scale [ Time Frame: Prior to and immediately following assigned intervention ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 15, 2009
First Posted: June 17, 2009
Last Update Posted: December 22, 2011
Last Verified: June 2009

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