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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04490291
Enrollment
42
Registered
2020-07-29
Start date
2018-08-01
Completion date
2020-05-25
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Spine Disease

Keywords

community health center, integrated pain team

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.

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.

Interventions

OTHERchronic pain team

enrollment in chronic pain team at study site

OTHERchiropractic team

enrollment in chiropractic team/intervention at study site

Sponsors

Logan University
CollaboratorUNKNOWN
Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* referred by PCP to either intervention at study site

Exclusion criteria

* active cancer diagnosis

Design outcomes

Primary

MeasureTime frameDescription
change in Pain Disability Questionnaire (PDQ) score6-12 month6-12 month follow up pain score - (minus) baseline. scores range from 0 (no pain or disability) to 150 (severe pain and disability)

Secondary

MeasureTime frameDescription
prescription opioid weaning6-12 monthsability to successfully wean off opioid prescription

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026