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Patient Response to Spinal Manipulation - Pilot Study (PRiSM)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HVLA-SM
Sponsored by
Palmer College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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?

Sites / Locations

  • Palmer College of Chiropractic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HVLA-SM

Arm Description

High velocity, low amplitude lumbo-pelvic manipulation

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2012
Last Updated
May 5, 2017
Sponsor
Palmer College of Chiropractic
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT01562756
Brief Title
Patient Response to Spinal Manipulation - Pilot Study
Acronym
PRiSM
Official Title
Pilot for Patient Response to Spinal Manipulation (PRiSM)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palmer College of Chiropractic
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of Iowa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HVLA-SM
Arm Type
Experimental
Arm Description
High velocity, low amplitude lumbo-pelvic manipulation
Intervention Type
Other
Intervention Name(s)
HVLA-SM
Intervention Description
High velocity, low amplitude spinal manipulation
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits
Title
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.
Description
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.
Time Frame
Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Xia, PhD
Organizational Affiliation
Palmer College of Chiropractic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palmer College of Chiropractic
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Feasibility/pilot study

Learn more about this trial

Patient Response to Spinal Manipulation - Pilot Study

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