Low Back Pain
Conditions
Keywords
low back pain, spinal manipulation, manual therapy, placebo
Brief summary
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.
Interventions
OTHERspinal manipulation
Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain
Sham spinal manipulation intended to mimic the studied spinal manipulation
OTHEREnhanced 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
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale | 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. |
| Believability of Placebo | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 2 Weeks in Low Back Extension Range of Motion | 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 | 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 | Change from Baseline at 2 weeks | Low back left sidebending range of motion was measured in degrees using a gravity inclinometer |
| Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion | Change from Baseline at 2 weeks | Low back flexion range of motion was measured in degrees using a gravity inclinometer |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Spinal Manipulative Therapy Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks | 28 |
| Sham Spinal Manipulative Therapy Received a sham spinal manipulative therapy for 6 sessions over 2 weeks. | 27 |
| 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. | 27 |
| Natural History These participants sat quietly for 5 minutes during the initial and final testing sessions. | 28 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Sham Spinal Manipulative Therapy | Enhanced Sham Spinal Manipulative Therapy | Spinal Manipulative Therapy | Natural History | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 27 Participants | 28 Participants | 28 Participants | 110 Participants |
| Age, Continuous | 33.22 years STANDARD_DEVIATION 13.29 | 31.56 years STANDARD_DEVIATION 11.85 | 32.07 years STANDARD_DEVIATION 10.98 | 29.85 years STANDARD_DEVIATION 12.09 | 31.68 years STANDARD_DEVIATION 11.85 |
| Region of Enrollment United States | 27 participants | 27 participants | 28 participants | 28 participants | 110 participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 21 Participants | 19 Participants | 77 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 7 Participants | 9 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 27 | 0 / 27 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 | 0 / 27 | 0 / 28 |
Outcome results
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
Time frame: baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Manipulative Therapy | Believability of Placebo | 67 percentage of participants |
| Sham Spinal Manipulative Therapy | Believability of Placebo | 37 percentage of participants |
| Enhanced Sham Spinal Manipulative Therapy | Believability of Placebo | 78 percentage of participants |
p-value: <0.01Chi-squared
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
Time frame: Change from Baseline at 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale | 11.23 units on a scale | Standard Deviation 14.01 |
| Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale | 14.03 units on a scale | Standard Deviation 17.88 |
| Enhanced Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale | 9.44 units on a scale | Standard Deviation 25.9 |
| Natural History | Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale | 8.20 units on a scale | Standard Deviation 12.64 |
p-value: >0.05Repeated Measure ANOVA
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.
Time frame: Change from Baseline at 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index | 4.46 units on a scale | Standard Deviation 8.28 |
| Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index | 2.08 units on a scale | Standard Deviation 7.36 |
| Enhanced Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index | 2.69 units on a scale | Standard Deviation 8.33 |
| Natural History | Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index | 2.54 units on a scale | Standard Deviation 8.47 |
p-value: >0.05Repeated Measure ANOVA
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.
Time frame: baseline and immediately following their assigned intervention during the initial session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Manipulative Therapy | Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale | 8.14 units on a scale | Standard Deviation 20.48 |
| Sham Spinal Manipulative Therapy | Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale | -3.04 units on a scale | Standard Deviation 12.92 |
| Enhanced Sham Spinal Manipulative Therapy | Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale | 1.22 units on a scale | Standard Deviation 16.03 |
| Natural History | Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale | -2.93 units on a scale | Standard Deviation 17.84 |
p-value: 0.05Repeated Measure ANOVA
Primary
Expectation for Treatment Effectiveness
how helpful participants expect the assigned intervention will be in decreasing their low back pain
Time frame: baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Manipulative Therapy | Expectation for Treatment Effectiveness | 54 percent expecting less pain |
| Sham Spinal Manipulative Therapy | Expectation for Treatment Effectiveness | 26 percent expecting less pain |
| Enhanced Sham Spinal Manipulative Therapy | Expectation for Treatment Effectiveness | 59 percent expecting less pain |
| Natural History | Expectation for Treatment Effectiveness | 11 percent expecting less pain |
p-value: 0.01Chi-squared
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
Time frame: Change from Baseline at 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Extension Range of Motion | -1.50 degrees | Standard Deviation 9.58 |
| Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Extension Range of Motion | -0.07 degrees | Standard Deviation 11.26 |
| Enhanced Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Extension Range of Motion | 1.26 degrees | Standard Deviation 4.95 |
| Natural History | Change From Baseline at 2 Weeks in Low Back Extension Range of Motion | -0.21 degrees | Standard Deviation 7.82 |
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
Time frame: Change from Baseline at 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion | 1.58 degrees | Standard Deviation 8.65 |
| Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion | 2.67 degrees | Standard Deviation 13.91 |
| Enhanced Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion | -0.33 degrees | Standard Deviation 9.55 |
| Natural History | Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion | -0.54 degrees | Standard Deviation 9.25 |
p-value: >0.05Repeated Measure ANOVA
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
Time frame: Change from Baseline at 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion | 2.15 degrees | Standard Deviation 8.04 |
| Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion | -0.15 degrees | Standard Deviation 6.37 |
| Enhanced Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion | 1 degrees | Standard Deviation 6.66 |
| Natural History | Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion | -1.36 degrees | Standard Deviation 6.41 |
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
Time frame: Change from Baseline at 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion | 0.92 degrees | Standard Deviation 8.68 |
| Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion | -0.19 degrees | Standard Deviation 1.24 |
| Enhanced Sham Spinal Manipulative Therapy | Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion | 0.63 degrees | Standard Deviation 7.53 |
| Natural History | Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion | 0.50 degrees | Standard Deviation 9.5 |