Patient Response to Spinal Manipulation (PRiSM)
This is a biomechanical study which is Project 1 in the Developmental Center for Clinical and Translational Research in Chiropractic (DCRC I) (NIH/NCCAM grant 1 U19 AT004663-01; principal investigator Christine Goertz, DC, PhD). This study is designed to monitor both physiological and patient self-report outcome variables. In addition, as there is little quantitative information on Spinal Manipulation Technique procedures reported in clinical trials, the study is designed to collect preliminary kinetic measures of the spinal manipulation technique delivery (i.e. force-time profiles).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Patient Response to Spinal Manipulation|
- Patient-Centered Outcome Measurements (Visual Analog Scale, Roland-Morris, Patient Reported Outcomes Measurement Information Scale-29) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Visual Analog Scale, Roland-Morris, Patient Reported Outcomes Measurement Information Scale-29, Lumbar-spine Stiffness, and Flexion-Relaxation
- Kinetic Measures (Thrust Contact Force & Spinal Segment Load) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Lumbar-spine Stiffness, Flexion-Relaxation, Thrust Contact Force & Spinal Segment Load
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental High Velocity Low Amplitude Spinal Manipulation
High Velocity Low Amplitude Spinal Manipulation
Participants with narrowly defined chronic low back pain will be included in this study. Each participant will be treated 12 times over the course of 6 weeks. The following data will be collected: participant characteristics that may predict outcome or be modifiers of force used by provider (gender, age, height, weight, and Body Mass Index); spinal segment load during the pre-load and thrusting phases (force and moment in the pre-load phase, peak load, loading rate, and thrust duration; physiological measures (posterior-anterior global stiffness and flexion-relaxation); patient-centered outcomes of back pain and function; and concomitant medications and treatments.
Study participants (n= 80) will be recruited from the Quad Cities metro area. A team of experienced chiropractic clinicians working at the Palmer Center for Chiropractic Research will treat study participants. Each of the study participants will receive 2 High Velocity Low Amplitude Spinal Manipulation treatment visits per week over a 6 week period. The physiological assessments will be performed immediately before and after Spinal Manipulation delivery during treatment visits 1, 5 & 12 (6 sets of assessments in total). During these same treatment visits, we will also capture the kinetic measures during Spinal Manipulation delivery for spinal segment load analysis. We will further collect thrusting force-time profiles of all Spinal Manipulation delivered in the course of treatment for thrust contact force analysis. Participant patient-centered outcomes will be measured at baseline 1, treatment visits 1, 6, and 13.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670292
|United States, Iowa|
|Palmer College of Chiropractic|
|Davenport, Iowa, United States, 52803|
|Principal Investigator:||Ting Xia, PhD||Palmer College of Chiropractic|