Patient Response to Spinal Manipulation - Pilot Study

Low Back Pain Clinical Trial

— PRiSM  

Official title:

Pilot for Patient Response to Spinal Manipulation (PRiSM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562756
• Other study ID #: PRiSM Pilot
• Secondary ID: U19AT004663
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2012
• Last updated: September 19, 2016
• Start date: February 2012
• Est. completion date: May 2012

Study information

• Verified date: September 2016
• Source: Palmer College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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?

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

Intervention

Other:
• HVLA-SM
High velocity, low amplitude spinal manipulation

Locations

Country	Name	City	State
United States	Palmer College of Chiropractic	Davenport	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Palmer College of Chiropractic	National Center for Complementary and Integrative Health (NCCIH), University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological Assessment (Posterior-Anterior Global Stiffness & Flexion-Relaxation)		2 weeks	No
Secondary	Kinetic Measures & Patient-Centered Outcome Measurements (VAS, Roland-Morris, PROMIS-29)		2 weeks	No