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

December 21, 2011 updated by: University of Florida

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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:
  • manual therapy
  • spinal manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numeric Rating Scale
Time Frame: Prior to and immediately following assigned intervention
Prior to and immediately following assigned intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Steven Z George, PhD, University of Florida Department of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

December 22, 2011

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 343-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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