Patient Response to Spinal Manipulation - Pilot Study — PRiSM  

Low Back Pain Clinical Trial

Official title: Pilot for Patient Response to Spinal Manipulation (PRiSM)

Status Completed

Clinical Trial Summary

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will pilot the study intended to pursue the following specific aims:

• Collect preliminary estimates of variability and effect size to identify if physiological measures predict patient-centered outcomes in patients with chronic low back pain; and

• Collect preliminary estimates of variability and effect size to determine if differences in spinal manipulation delivery, as estimated by thrust contact force and spinal segment load, are related to patient-centered outcomes in patients with chronic low back pain.

Clinical Trial Description

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will pilot the study intended to pursue the following specific aims:

• Collect preliminary estimates of variability and effect size to identify if physiological measures predict patient-centered outcomes in patients with chronic low back pain; and

• Collect preliminary estimates of variability and effect size to determine if differences in spinal manipulation delivery, as estimated by thrust contact force and spinal segment load, are related to patient-centered outcomes in patients with chronic low back pain.

The specific aims will be achieved through the conduct of a prospective observational study to evaluate the delivery of HVLA-SM using subjective patient self-report and objective biomechanical and physiological measures.

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, height, weight, BMI, duration of chronic LBP, etc); spinal joint load during the pre-load and thrusting phases (force and moment in the pre-load phase, peak force and moment and loading rate during the thrust phase); physiological measures (spinal stiffness and flexion-relaxation); patient reported outcomes of back pain and function; and concomitant medications and treatments.

This study will identify associations between physiological and participant self-report outcomes that can be tested in subsequent studies. It may also identify potential spinal joint load variations in SM delivery contributing to clinical improvement that could be validated in future studies.

Study participants (n=80) will be recruited from the Quad Cities metro area. A team of experienced chiropractic clinicians working at the PCCR will treat study participants. Each of the study participants will receive 2 HVLA-SM treatment visits per week over a 6 week period. The physiological assessments will be performed immediately before and after SM deliver during treatment visits 1, 5 & 12 (6 sets of assessment in total). During these same treatment visits, we will also capture the kinetic measures during SM deliver for spinal joint load analysis. Participant self-report outcomes will be measured at baseline 1, treatment visits 1, 5, and 12.

After the equipment has been modified, the research clinicians will be trained to familiarize themselves with the new set-up. Following this we will test and refine the data collection protocol in this pilot study of five healthy volunteers. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

• NCT number: NCT01562756
• Study type: Interventional
• Source: Palmer College of Chiropractic
• Status: Completed
• Phase: Phase 2
• Start date: February 2012
• Completion date: May 2012