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

NCT04490291 | Completed DMC

• 1 other identifier: RD04240531
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Spine Disease

Keywords

community health center; integrated pain team

Outcome Measures

Primary Outcomes (1)

• change in Pain Disability Questionnaire (PDQ) score

  6-12 month follow up pain score - (minus) baseline. scores range from 0 (no pain or disability) to 150 (severe pain and disability)

  6-12 month

Secondary Outcomes (1)

• prescription opioid weaning

  6-12 months

Interventions

chronic pain team OTHER

enrollment in chronic pain team at study site

chiropractic team OTHER

enrollment in chiropractic team/intervention at study site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

active patients at an urban federally-qualified health center

You may qualify if:

• referred by PCP to either intervention at study site

You may not qualify if:

• active cancer diagnosis

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Logan University: collaborator

Study Sites (1)

Affinia Healthcare

St Louis, Missouri, 63118, United States

Location

MeSH Terms

Conditions

Chronic Pain; Spinal Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Medicine and Pediatrics

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: July 29, 2020
• Study Start: August 1, 2018
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after publication, available indefinitely
• Access Criteria: by request

Locations

US (1)