The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
This study is currently recruiting participants.
Verified September 2012 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168999
First received: July 22, 2010
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to determine whether a novel placebo for comparison to spinal manipulation is believable and creates similar expectation for treatment effectiveness as the studied spinal manipulation technique. Additionally, we wish to compare outcomes related to low back pain, function, and pain sensitivity between people receiving the placebo, spinal manipulation, and no therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Other: spinal manipulation Other: sham spinal manipulation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Mechanisms of Manual Therapy in the Treatment of Low Back Pain |
Resource links provided by NLM:
Further study details as provided by University of Florida:
Primary Outcome Measures:
- believability of placebo [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo
- expectation for treatment effectiveness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]how helpful participants expect the assigned intervention will be in decreasing their low back pain
- clinical pain as measured by a numeric rating scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
- disability as measured by the oswestry functional questionnaire [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]oswestry functional questionnaire to measure functional limitations related to low back pain
- pain sensitivity as measured by a numeric rating scale and a visual analog scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]self report of pain resulting from standardized thermal and pressure pain stimuli
Secondary Outcome Measures:
- low back range of motion and strength [ Time Frame: 2 week ] [ Designated as safety issue: No ]measures of low back range of motion and abdominal strength
| Estimated Enrollment: | 133 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: spinal manipulation
a spinal manipulation known to be effective in the treatment of low back pain for some individuals
|
Other: spinal manipulation
a spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain
|
|
Placebo Comparator: sham spinal manipulation
a sham spinal manipulation intended to mimic the studied spinal manipulation
|
Other: sham spinal manipulation
a sham spinal manipulation intended to mimic the studied spinal manipulation
|
|
No Intervention: natural history
No intervention is provided to participants in this arm of the study
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- currently experiencing low back pain which does not extend below the knees
- rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
- appropriate for conservative management of low back pain
- english speaking
Exclusion Criteria:
- surgery to the low back over the past 6 months
- systemic disease known to effect sensation
- other chronic pain condition unrelated to low back pain
- fracture as a cause of low back pain
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168999
Contacts
| Contact: Joel E Bialosky, PhD | 352-273-8636 | bialosky@phhp.ufl.edu |
Locations
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Joel E Bialosky, PhD 352-273-8636 bialosky@phhp.ufl.edu | |
| Principal Investigator: Joel E Bialosky, PhD | |
Sponsors and Collaborators
University of Florida
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01168999 History of Changes |
| Other Study ID Numbers: | 345-2009 |
| Study First Received: | July 22, 2010 |
| Last Updated: | September 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Florida:
|
low back pain spinal manipulation manual therapy placebo |
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 23, 2013