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NCT04118595 · ClinicalTrials.gov registry record · NA

Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults

A NA study of Chronic Pain and Acute Musculoskeletal Pain, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
330
Enrollment target
1
Study location

NCT04118595: Completed NA study of Chronic Pain and Acute Musculoskeletal Pain, sponsored by University of North Carolina, Chapel Hill.

NCT04118595 is a NA study of Chronic Pain and Acute Musculoskeletal Pain that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 330 participants, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04118595, a NA study of Chronic Pain and Acute Musculoskeletal Pain, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
330 participants
Enrollment target
1
Study location

Study Summary

The investigators have developed a three component intervention to support shared decision-making during the early recovery phase for older adults who present to the emergency department (ED) or orthopedic urgent care with acute musculoskeletal pain. The first component is a brief interactive video to enhance patient knowledge and self-efficacy regarding treatment options with the intent of facilitating conversations between patients and emergency providers. The second component is a protocol-guided phone conversation (telecare) between a nurse care manager and the patient at 48-72 hours following discharge to assess pain severity and interference with daily activities, review analgesic use and side effects and recovery-promoting behaviors, and discuss adjustments to the patients treatment. The third component is communication with the patient's primary care provider following the telecare call to inform them of the patient's condition and treatment plan and encourage primary care followup. The short-term objective of this project is to test the efficacy of this intervention to reduce the transition from acute to chronic musculoskeletal pain among older adults and obtain data to inform implementation. The investigators will conduct a three-arm randomized controlled trial with adults aged 50 years and older who present to the ED or orthopedic urgent care with acute musculoskeletal pain. Patients will be randomized to (1) the full intervention (video + telecare + communication with primary provider), (2) video alone, or (3) usual care. The primary outcome will be pain, measured longitudinally over the course of the year following the acute care visit. Secondary outcomes will include physical function, analgesic side effects and adverse events, opioid use, depression and anxiety symptoms, sleep duration and quality, and healthcare utilization at one, three, six, and twelve months. Secondary analyses will (1) examine whether the intervention has its effect by promoting

Primary Outcome

The Brief Pain Inventory-Short Form (BPI-SF) is an 11-item measure of pain severity and pain interference. Patients will rate their pain severity and interference over the past week on a 0-10 numeric scale at 3 discrete time periods (1, 3, and 6 months). End points for the severity items include 0 which equals "no pain" and 10 which equals "pain as bad as you can imagine." End points for the interference items include 0 which equals "does not interfere" and 10 "completely interferes." Higher sco

Interventions

  • BEHAVIORAL Educational Video
  • BEHAVIORAL Telecare
  • BEHAVIORAL Correspondence with Primary Care Provider

Study Locations (1)

North Carolina

  • University of North Carolina Hospitals - Chapel Hill

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2020-02-03
Est. Completion 2023-06-22
Phase NA

What the finished NCT04118595 record still lists

NCT04118595 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (57% lower).

The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 3 interventions - of which Educational Video is the first listed.

NCT04118595 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT04118595 about?

NCT04118595 is a clinical study titled "Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults". The investigators have developed a three component intervention to support shared decision-making during the early recovery phase for older adults who present to the emergency department (ED) or orthopedic urgent care with acute musculoskeletal pain. The first component is a brief interactive video ...

What is the current status of trial NCT04118595?

This trial is currently completed. It is a NA study. The enrollment target is 330 participants. The study started on 2020-02-03. Estimated completion is 2023-06-22.

What conditions does trial NCT04118595 study?

This clinical trial studies the following conditions: Chronic Pain, Acute Musculoskeletal Pain.

What interventions are being tested in trial NCT04118595?

The interventions under investigation include: Educational Video (BEHAVIORAL), Telecare (BEHAVIORAL), Correspondence with Primary Care Provider (BEHAVIORAL).

Who is sponsoring clinical trial NCT04118595?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04118595 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Chronic Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04118595's enrollment target sits among peer trials

330 46th of 301 higher than 256 of 301 other Chronic Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04118595, the US trial registry maintained by the National Library of Medicine. NCT04118595 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.