Patient Response to Spinal Manipulation (PRiSM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Iowa
Information provided by (Responsible Party):
Palmer College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01670292
First received: August 2, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Low Back Pain
Other: HVLA-SM
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Response to Spinal Manipulation

Resource links provided by NLM:


Further study details as provided by Palmer College of Chiropractic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
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)
Arms Assigned Interventions
Experimental: HVLA-SM
Experimental High Velocity Low Amplitude Spinal Manipulation
Other: HVLA-SM
High Velocity Low Amplitude Spinal Manipulation

Detailed 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, 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Retension 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670292

Locations
United States, Iowa
Palmer College of Chiropractic
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Palmer College of Chiropractic
University of Iowa
Investigators
Principal Investigator: Ting Xia, PhD Palmer College of Chiropractic
  More Information

No publications provided

Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT01670292     History of Changes
Other Study ID Numbers: PRiSM Study, U19AT004663
Study First Received: August 2, 2012
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Palmer College of Chiropractic:
Low Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014