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The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
This study has been completed.
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168999
First received: July 22, 2010
Last updated: October 5, 2015
Last verified: October 2015
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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 Other: Enhanced sham spinal manipulation | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) 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: baseline ]Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT
- Expectation for Treatment Effectiveness [ Time Frame: baseline ]how helpful participants expect the assigned intervention will be in decreasing their low back pain
- Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale [ Time Frame: Change from Baseline at 2 weeks ]A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
- Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index [ Time Frame: Change from Baseline at 2 weeks ]The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
- Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale [ Time Frame: baseline and immediately following their assigned intervention during the initial session ]Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating "no pain at all" and 100 mm indicating "the worst pain imaginable".
Secondary Outcome Measures:
- Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]Low back flexion range of motion was measured in degrees using a gravity inclinometer
- Change From Baseline at 2 Weeks in Low Back Extension Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]Low back extension range of motion was measured in degrees using a gravity inclinometer
- Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]Low back right sidebending range of motion was measured in degrees using a gravity inclinometer
- Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion [ Time Frame: Change from Baseline at 2 weeks ]Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
| Enrollment: | 110 |
| Study Start Date: | September 2009 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 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
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
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
|
|
|
Placebo Comparator: Enhanced sham spinal manipulation
a sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
|
Other: Enhanced sham spinal manipulation
Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168999
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168999
Locations
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Joel Bialosky, PT, PhD | University of Florida |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01168999 History of Changes |
| Other Study ID Numbers: |
345-2009 |
| Study First Received: | July 22, 2010 |
| Results First Received: | May 10, 2013 |
| Last Updated: | October 5, 2015 |
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 June 23, 2017