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Patient Response to Spinal Manipulation - Pilot Study (PRiSM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562756
First Posted: March 26, 2012
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
University of Iowa
Information provided by (Responsible Party):
Palmer College of Chiropractic
  Purpose
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.

Condition Intervention
Low Back Pain Other: HVLA-SM

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • 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 [ Time Frame: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits ]
    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. [ Time Frame: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits ]
    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.


Enrollment: 6
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 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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?
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562756


Locations
United States, Iowa
Palmer College of Chiropractic
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Palmer College of Chiropractic
National Center for Complementary and Integrative Health (NCCIH)
University of Iowa
Investigators
Principal Investigator: Ting Xia, PhD Palmer College of Chiropractic
  More Information

Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT01562756     History of Changes
Other Study ID Numbers: PRiSM Pilot
U19AT004663 ( U.S. NIH Grant/Contract )
First Submitted: March 22, 2012
First Posted: March 26, 2012
Results First Submitted: March 21, 2017
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Feasibility/pilot study

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