An Observational Study of Integrated Chronic Pain Management in a Community Health Center
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|ClinicalTrials.gov Identifier: NCT04490291|
Recruitment Status : Completed
First Posted : July 29, 2020
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment|
|Chronic Pain Spine Disease||Other: chronic pain team Other: chiropractic team|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||42 participants|
|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|
- Other: chronic pain team
enrollment in chronic pain team at study site
- Other: chiropractic team
enrollment in chiropractic team/intervention at study site
- 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)
- prescription opioid weaning [ Time Frame: 6-12 months ]ability to successfully wean off opioid prescription
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
|United States, Missouri|
|Saint Louis, Missouri, United States, 63118|