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An Observational Study of Integrated Chronic Pain Management in a Community Health Center

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.
 
ClinicalTrials.gov Identifier: NCT04490291
Recruitment Status : Completed
First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
Logan University
Information provided by (Responsible Party):
Chrisotpher Prater, Washington University School of Medicine

Brief Summary:
This was a prospective observational study with the primary objective of quantifying a change in pain scores after 6-12 months of two separate interventions within the study site (pain team and chiropractic team). Target enrollment was 30 participants for each intervention. The primary outcome was a change from baseline of the Pain Disability Questionnaire (PDQ), the study tool. Secondary outcomes were reduction of opioid dose by morphine equivalent daily dose, and its effect on PDQ scores.

Condition or disease Intervention/treatment
Chronic Pain Spine Disease Other: chronic pain team Other: chiropractic team

Detailed Description:

Data collection After participants were enrolled, they completed a baseline PDQ while waiting for their appointment. Participants continued to see the intervention group, PCP, and other medical providers as determined by their health providers independent of this study's protocol. Another PDQ was collected at an intended 6 - 12 months later. Demographic information was collected by manual chart review in the electronic medical record NextGen (NextGen EHR, Nextgen Healthcare, Inc. Irvine, CA, USA).

Variables collected included age, sex, race, BMI, insurance type, preferred language, presence of another pain diagnosis (e.g. knee pain), active mental health diagnosis (including substance abuse), diagnosis of hypertension or diabetes, and morphine equivalent dose (MED); one post-hoc variable was recorded: timing of follow-up survey in relation to the 2019 coronavirus (COVID-19) pandemic, defined as before/after March 1, 2020. Intervention type was analyzed as an independent variable since the study was not designed as a comparison of interventions. All data was stored in an encrypted Excel database on a password-protected laptop. Consent forms were stored in a locked cabinet accessible only to the PI.

Stata 16.0 (StataCorp, LLC, College Station, TX, USA) was used for statistical analysis. PDQ scores at baseline and follow-up were tested for statistical significance using paired t-tests. Univariate analysis was performed on individual categorical variables and change in PDQ using two-sample t-tests. Multivariate linear regression was used to determine associations of these factors to the outcome. Variables were excluded from regression models if there was a subgroup size of six or less.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: An Observational Study of Integrated Chronic Pain Management in a Community Health Center
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : May 25, 2020
Actual Study Completion Date : May 25, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: chronic pain team
    enrollment in chronic pain team at study site
  • Other: chiropractic team
    enrollment in chiropractic team/intervention at study site


Primary Outcome Measures :
  1. change in Pain Disability Questionnaire (PDQ) score [ Time Frame: 6-12 month ]
    6-12 month follow up pain score - (minus) baseline. scores range from 0 (no pain or disability) to 150 (severe pain and disability)


Secondary Outcome Measures :
  1. prescription opioid weaning [ Time Frame: 6-12 months ]
    ability to successfully wean off opioid prescription



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
active patients at an urban federally-qualified health center
Criteria

Inclusion Criteria:

  • referred by PCP to either intervention at study site

Exclusion Criteria:

  • active cancer diagnosis

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): NCT04490291


Locations
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United States, Missouri
Affinia Healthcare
Saint Louis, Missouri, United States, 63118
Sponsors and Collaborators
Washington University School of Medicine
Logan University
  Study Documents (Full-Text)

Documents provided by Chrisotpher Prater, Washington University School of Medicine:
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Responsible Party: Chrisotpher Prater, Assistant Professor in Medicine and Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04490291    
Other Study ID Numbers: RD04240531
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: methodology and data will be available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: after publication, available indefinitely
Access Criteria: by request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chrisotpher Prater, Washington University School of Medicine:
community health center
integrated pain team
Additional relevant MeSH terms:
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Spinal Diseases
Chronic Pain
Pain
Neurologic Manifestations
Bone Diseases
Musculoskeletal Diseases