Clinical trial NCT01168999: The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Official title: The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Keywords: low back pain
spinal manipulation
manual therapy
placebo
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Believability of Placebo
timeFrame: baseline
measure: Expectation for Treatment Effectiveness
timeFrame: baseline
measure: Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
timeFrame: Change from Baseline at 2 weeks
measure: Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
timeFrame: Change from Baseline at 2 weeks
measure: Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
timeFrame: baseline and immediately following their assigned intervention during the initial session
Secondary outcomes:
measure: Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
timeFrame: Change from Baseline at 2 weeks
measure: Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
timeFrame: Change from Baseline at 2 weeks
measure: Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
timeFrame: Change from Baseline at 2 weeks
measure: Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
timeFrame: Change from Baseline at 2 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Joel Bialosky, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.