Patient Response to Spinal Manipulation (PRiSM)

Palmer College of Chiropractic

Status

Completed

Conditions

Low Back Pain

Treatments

Other: HVLA-SM

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01670292

U19AT004663 (U.S. NIH Grant/Contract)

PRiSM Study

Details and patient eligibility

About

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).

Full description

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, and loading rate); physiological measures (posterior-anterior global stiffness and flexion-relaxation); patient-centered outcomes of back pain and function; and adverse events.

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. Participant patient-centered outcomes will be measured at baseline 1, and treatment visits 6 and 13. For simplicity, data collection time points will be named as baseline, after 2 weeks, and after 6 weeks.

Enrollment

82 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

NRS score, AVERAGE within the past 24 hours
Must be ≥4 at the phone screen or baseline 1 visit
Must be ≥2 at phone screen, baseline 1 and baseline 2 visits
Roland Morris Disability ≥6
Age 21-65
Signed informed consent document
Chronic (12+ weeks) low back pain

Exclusion criteria

Compliance concerns
No manipulable lesion in L1-L5 or SI joints
The absence of typical palpatory characteristics as well as the absence of a global assessment that would indicate that spinal manipulation is likely to generate a positive therapeutic effect, even without the presence of standard palpatory findings
Ongoing treatment for low back pain by outside provider
Comorbid conditions
Serious concomitant illness
Inflammatory or destructive spinal tissue change
Ankylosing Spondylytis
Fibromyalgia
Rheumatoid Arthritis
Confirmed or suspected disc herniation with neurological signs
Neuromuscular disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis
Spinal surgery <6 months
Suspicion of drug or alcohol dependence or abuse
Uncontrolled hypertension
Lower extremity peripheral arterial disease
Undetermined, infections or visceral source of low back pain
Other comorbid conditions prohibiting treatment and/or testing
Safety concerns
Bleeding disorders
Contraindications to High Velocity Low Amplitude Spinal Manipulation
Inability to tolerate or obtain positon for flexion-relaxation test without condition aggravation
Inability to tolerate or perform/receive any study procedure without condition aggravation
Quebec Task Force (QTF) criterion 4-11:
QTF 4: Pain + radiation to upper/lower limb with neurologic signs
QTF 5: Presumptive compression of a spinal nerve root on a simple roentgenogram
QTF 6: Compression of a spinal nerve root confirmed by specific imaging techniques
QTF 7: Spinal Stenosis
QTF 8: Postsurgical status, 1-6 months after intervention
QTF 9: Postsurgical status, >6 months after intervention
QTF 10: Chronic pain syndrome
QTF 11: Other diagnoses
Pregnancy
Pacemaker or defibrillator
Inability to read or verbally comprehend English
Joint replacement
Use of spinal manipulation within past 4 weeks
Sensitivity to adhesive
Diagnostic procedures other than x-ray/UA necessary
BDI-II ≥29
Retention of legal advice and open or pending case related to low back pain
BMI ≥40
Unwilling to have low back and wrist shaved
Moving from Quad Cities area within next 8 weeks
Unwilling to postpone treatments for low back pain from another provider
Seeking or receiving compensation for any disability