Patient Response to Spinal Manipulation - Pilot Study (PRiSM)

This study has been completed.
Sponsor:
Collaborators:
University of Iowa
Information provided by (Responsible Party):
Palmer College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01562756
First received: March 22, 2012
Last updated: August 2, 2012
Last verified: March 2012
  Purpose

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.

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

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

Resource links provided by NLM:


Further study details as provided by Palmer College of Chiropractic:

Primary Outcome Measures:
  • Physiological Assessment (Posterior-Anterior Global Stiffness & Flexion-Relaxation) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kinetic Measures & Patient-Centered Outcome Measurements (VAS, Roland-Morris, PROMIS-29) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HVLA-SM
High velocity, low amplitude lumbo-pelvic manipulation
Other: HVLA-SM
High velocity, low amplitude spinal manipulation

Detailed 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.

  Eligibility

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

Inclusion Criteria:

  • Age 21-65
  • Signed informed consent document
  • Chronic (12+ weeks) low back pain
  • NRS > 2 at phone screen and baseline visit 1 and baseline visit 2

Exclusion Criteria:

  • Compliance concerns such as refusal to shave body hair
  • No manipulable lesion in L3, L4, 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)
  • Comorbid Conditions:
  • Serious Contaminant Illness
  • Inflammatory or Destructive Spinal Tissue change
  • Ankylosing Spondylitis
  • Fibromyalgia
  • Rheumatoid Arthritis
  • Neuromuscular Disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis)
  • Spinal Surgery < 6 mo
  • Suspicion of drug or alcohol abuse
  • Uncontrolled hypertension
  • Peripheral Arterial Disease
  • Undetermined, infectious or visceral source of LBP
  • Other comorbid conditions prohibiting treatment and/or testing
  • Safety Concerns
  • Bleeding Disorders
  • Contraindications to HVLA-SM
  • Quebec Task Force (QTF) criterion 4-11:
  • QTF 4: Pain + radiation to upper/lower limb with 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
  • Sensitivity to adhesive
  • Additional diagnostic procedures other than x-ray necessary
  • BDI-II > 29
  • Retention of legal advice and open or pending case related to LBP
  • BMI > 40
  • Unwilling to have low back and wrist shaved
  • 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: NCT01562756

Locations
United States, Iowa
Palmer College of Chiropractic
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Palmer College of Chiropractic
University of Iowa
  More Information

No publications provided

Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT01562756     History of Changes
Other Study ID Numbers: PRiSM Pilot, U19AT004663
Study First Received: March 22, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014