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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spinal manipulation | Active Comparator | a spinal manipulation known to be effective in the treatment of low back pain for some individuals |
|
| sham spinal manipulation | Placebo Comparator | a sham spinal manipulation intended to mimic the studied spinal manipulation |
|
| natural history | No Intervention | No intervention is provided to participants in this arm of the study | |
| Enhanced sham spinal manipulation | Placebo Comparator | 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" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal manipulation | Other | Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Believability of Placebo | 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 | baseline |
| Expectation for Treatment Effectiveness | how helpful participants expect the assigned intervention will be in decreasing their low back pain | baseline |
| Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale | 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 |
| Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index | 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 from Baseline at 2 weeks |
| Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale | 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". | baseline and immediately following their assigned intervention during the initial session |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion | Low back flexion range of motion was measured in degrees using a gravity inclinometer | Change from Baseline at 2 weeks |
| Change From Baseline at 2 Weeks in Low Back Extension Range of Motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Bialosky, PT, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24361109 | Derived | Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27. |
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The study was undertaken in a lab on the University of Florida. Participants were recruited through written and electronic advertisement approved by the University of Florida Institutional Review Board. The first participant was enrolled in the study in November of 2009 and the final participant completed the study in January of 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Manipulative Therapy | Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks |
| FG001 | Sham Spinal Manipulative Therapy | Received a sham spinal manipulative therapy for 6 sessions over 2 weeks. |
| FG002 | Enhanced Sham Spinal Manipulative Therapy | Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks. |
| FG003 | Natural History | These participants sat quietly for 5 minutes during the initial and final testing sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Manipulative Therapy | Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks |
| BG001 | Sham Spinal Manipulative Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Believability of Placebo | 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 | Posted | Number | percentage of participants | baseline |
|
The study was conducted from November of 2009 until January of 2013. The occurrence of adverse events was monitored during the length of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Manipulative Therapy | Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joel Bialosky | University of Florida | 352-273-8636 | bialosky@phhp.ufl.edu |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| sham spinal manipulation | Other | Sham spinal manipulation intended to mimic the studied spinal manipulation |
|
| Enhanced sham spinal manipulation | Other | 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" |
|
Low back extension range of motion was measured in degrees using a gravity inclinometer |
| Change from Baseline at 2 weeks |
| Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion | Low back right sidebending range of motion was measured in degrees using a gravity inclinometer | Change from Baseline at 2 weeks |
| Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion | Low back left sidebending range of motion was measured in degrees using a gravity inclinometer | Change from Baseline at 2 weeks |
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
| BG002 | Enhanced Sham Spinal Manipulative Therapy | Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks. |
| BG003 | Natural History | These participants sat quietly for 5 minutes during the initial and final testing sessions. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Enhanced Sham Spinal Manipulative Therapy |
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks. |
| OG003 | Natural History | These participants sat quietly for 5 minutes during the initial and final testing sessions. |
|
|
|
| Primary | Expectation for Treatment Effectiveness | how helpful participants expect the assigned intervention will be in decreasing their low back pain | Posted | Number | percent expecting less pain | baseline |
|
|
|
|
| Primary | Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale | A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline at 2 weeks |
|
|
|
|
| Primary | Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline at 2 weeks |
|
|
|
|
| Primary | Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale | 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". | Posted | Mean | Standard Deviation | units on a scale | baseline and immediately following their assigned intervention during the initial session |
|
|
|
|
| Secondary | Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion | Low back flexion range of motion was measured in degrees using a gravity inclinometer | Posted | Mean | Standard Deviation | degrees | Change from Baseline at 2 weeks |
|
|
|
|
| Secondary | Change From Baseline at 2 Weeks in Low Back Extension Range of Motion | Low back extension range of motion was measured in degrees using a gravity inclinometer | Posted | Mean | Standard Deviation | degrees | Change from Baseline at 2 weeks |
|
|
|
| Secondary | Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion | Low back right sidebending range of motion was measured in degrees using a gravity inclinometer | Posted | Mean | Standard Deviation | degrees | Change from Baseline at 2 weeks |
|
|
|
| Secondary | Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion | Low back left sidebending range of motion was measured in degrees using a gravity inclinometer | Posted | Mean | Standard Deviation | degrees | Change from Baseline at 2 weeks |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Sham Spinal Manipulative Therapy | Received a sham spinal manipulative therapy for 6 sessions over 2 weeks. | 0 | 27 | 0 | 27 |
| EG002 | Enhanced Sham Spinal Manipulative Therapy | Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks. | 0 | 27 | 0 | 27 |
| EG003 | Natural History | These participants sat quietly for 5 minutes during the initial and final testing sessions. | 0 | 28 | 0 | 28 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |