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Completed

NCT Number: NCT04490291

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Affinia Healthcare

St Louis, Missouri, 63118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • referred by PCP to either intervention at study site

Exclusion criteria

  • active cancer diagnosis

Treatment and study plan

chronic pain team

Other

enrollment in chronic pain team at study site

chiropractic team

Other

enrollment in chiropractic team/intervention at study site

Primary outcomes

  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 outcomes

  1. prescription opioid weaning

    Time frame: 6-12 months

    ability to successfully wean off opioid prescription

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Logan University

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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