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

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ClinicalTrials.gov Identifier: NCT00922220
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : December 22, 2011
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Other: stationary bike Other: lumbar extension exercise Other: spinal manipulative therapy Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Effect of Physical Interventions for Low Back Pain
Study Start Date : October 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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

Publications of Results:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00922220     History of Changes
Other Study ID Numbers: 343-2004
First Posted: June 17, 2009    Key Record Dates
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