Back to resultsA Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
stationary bike
lumbar extension exercise
spinal manipulative therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, spinal manipulation, central sensitization, manual therapy
Eligibility 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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
stationary bike
lumbar extension exercises
spinal manipulative therapy
Arm Description
Participants rode a stationary bike for five minutes
Participants performed four sets of fifteen lumbar extension exercises over five minutes
Participants received spinal manipulative therapy to the low back
Outcomes
Primary Outcome Measures
Numeric Rating Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00922220
Brief Title
A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain
Official Title
Immediate Effect of Physical Interventions for Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, spinal manipulation, central sensitization, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stationary bike
Arm Type
Active Comparator
Arm Description
Participants rode a stationary bike for five minutes
Arm Title
lumbar extension exercises
Arm Type
Active Comparator
Arm Description
Participants performed four sets of fifteen lumbar extension exercises over five minutes
Arm Title
spinal manipulative therapy
Arm Type
Experimental
Arm Description
Participants received spinal manipulative therapy to the low back
Intervention Type
Other
Intervention Name(s)
stationary bike
Intervention Description
Participants rode a stationary bike for five minutes
Intervention Type
Other
Intervention Name(s)
lumbar extension exercise
Other Intervention Name(s)
press up
Intervention Description
Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes
Intervention Type
Other
Intervention Name(s)
spinal manipulative therapy
Other Intervention Name(s)
spinal manipulation, manual therapy
Intervention Description
participants received spinal manipulative therapy to the low back
Primary Outcome Measure Information:
Title
Numeric Rating Scale
Time Frame
Prior to and immediately following assigned intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Z George, Phd
Organizational Affiliation
University of Florida Department of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16911795
Citation
George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. doi: 10.1186/1471-2474-7-68.
Results Reference
result
PubMed Identifier
19797305
Citation
Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.
Results Reference
result
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A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain
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