Patient Response to Spinal Manipulation - Pilot Study (PRiSM)

Pilot for Patient Response to Spinal Manipulation (PRiSM)

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will conduct a pilot study for the purposes of testing equipment, finalizing data collection protocol, and training study personnel before conducting the full-scale trial.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: HVLA-SM

Detailed Description

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will conduct a pilot study for the purposes of testing equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial. Only feasibility data will be collected and reported for this pilot study.

The full-scale trial, titled as "Patient response to spinal manipulation" (Trial registration: NCT01670292 on clinicaltrials.gov), is the Project 1 of the Developmental Center for Clinical and Translational Science in Chiropractic (Award No. U19AT004663).

In the current pilot study, we test how research clinicians can treat patients under study measurement conditions and with equipment resulting in modified treatment procedures. This pilot study will also test spinal stiffness using 3 different methods on 2 study visits. We will also assess the function of low back muscles during standing and while bending forward on 2 visits. These measurements include placing sensors on the back with tape and measuring the electrical activity of low back muscles. Participants with low back pain are treated with side-lying high-velocity low-amplitude spinal manipulation by experienced research clinicians who are doctors of chiropractic. Specifically, we will recruit 6 participants who are 21 - 64 years old and have had low back pain for at least 3 months. Each participant will attend 1 baseline visit, 1 enrollment visit, and 4 treatment visits over a period of approximately 4 weeks. Following the baseline visit, participant eligibility will be determined. The enrollment visit will be scheduled on the same day as the first treatment visit. The following feasibility data will be collected:

• # of participants recruited
• # of participants consented
• # of participants enrolled
• # of participants who completed the study
• Total duration of the study from launch data to the final study visit

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Palmer College of Chiropractic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 21-65
• Signed informed consent document
• Chronic (12+ weeks) low back pain (LBP)
• Average pain within past 24 hours ≥ 2/10 at phone screen, 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HVLA-SM; High velocity, low amplitude lumbo-pelvic manipulation	Other: HVLA-SM; High velocity, low amplitude spinal manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study	Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.	Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.	Feasibility was measured by the study duration from study launch to collection of final study outcomes. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.	Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits

Collaborators and Investigators

• Sponsor: Palmer College of Chiropractic
• Collaborators: University of Iowa; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Ting Xia, PhD, Palmer College of Chiropractic

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 26, 2012

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PRiSM Pilot; U19AT004663 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Feasibility/pilot study