The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
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ClinicalTrials.gov Identifier: NCT01168999 |
Recruitment Status :
Completed
First Posted : July 23, 2010
Results First Posted : December 23, 2013
Last Update Posted : October 28, 2015
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Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Other: spinal manipulation Other: sham spinal manipulation Other: Enhanced sham spinal manipulation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | The Mechanisms of Manual Therapy in the Treatment of Low Back Pain |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |
Arm | Intervention/treatment |
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Active Comparator: spinal manipulation
a spinal manipulation known to be effective in the treatment of low back pain for some individuals
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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
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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
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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"
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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" |
- 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".
- 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

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01168999
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Joel Bialosky, PT, PhD | University of Florida |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT01168999 |
Other Study ID Numbers: |
345-2009 |
First Posted: | July 23, 2010 Key Record Dates |
Results First Posted: | December 23, 2013 |
Last Update Posted: | October 28, 2015 |
Last Verified: | October 2015 |
low back pain spinal manipulation manual therapy placebo |
Back Pain Low Back Pain Pain Neurologic Manifestations |