Phase 2
N=110
The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01168999 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Believability of Placebo — 67; 37; 78 percentage of participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- spinal manipulation (Other); sham spinal manipulation (Other); Enhanced sham spinal manipulation (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Believability of Placebo |
67; 37; 78 | <0.01 sig |
| PRIMARY Expectation for Treatment Effectiveness |
54; 26; 59; 11 | 0.01 sig |
| PRIMARY Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale |
11.23; 14.03; 9.44; 8.20 | >0.05 |
| PRIMARY Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index |
4.46; 2.08; 2.69; 2.54 | >0.05 |
| PRIMARY Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale |
8.14; -3.04; 1.22; -2.93 | 0.05 |
| SECONDARY Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion |
1.58; 2.67; -0.33; -0.54 | >0.05 |
| SECONDARY Change From Baseline at 2 Weeks in Low Back Extension Range of Motion |
-1.50; -0.07; 1.26; -0.21 | — |
| SECONDARY Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion |
0.92; -0.19; 0.63; 0.50 | — |
| SECONDARY Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion |
2.15; -0.15; 1; -1.36 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01168999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.