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Clinical Trials/NCT04124289
NCT04124289CompletedNot Applicable

A Pilot Study to Validate a Functional Pain Scale in Order to Improve the Patient Experience

The Guthrie Clinic1 site in 1 country49 target enrollmentStarted: October 29, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
49
Locations
1
Primary Endpoint
Change in pain score using functional pain scale questionnaire

Study Overview

Brief Summary

This will be an observational cohort study to evaluate pain measurement after surgery using a new functional pain scale.

Detailed Description

Patients admitted for orthopedic surgery may take part in this research. Participants will be assessed using three different pain scales: numeric rating scale (NRS), FACES pain scale and a new functional pain scale (FPS).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Completed orthopedic (hip or knee) surgery
  • English as primary language and able to read
  • Low risk as assessed by Opioid Risk Assessment Tool (ORAT)
  • No history of opioid abuse
  • Patients with a diagnosis of chronic pain other than the scheduled hip or knee meeting the above criteria may be included.

Exclusion Criteria

  • Previous diagnosis of cognitive impairment

Outcomes

Primary Outcomes

Change in pain score using functional pain scale questionnaire

Time Frame: Through study completion, an average of 4 days.

Change in pain measurement using new functional pain scale from baseline postoperatively until discharge. The functional pain scale is a scale of 10 descriptive words related to pain and ability to function, ranging from minimal to immobilizing

Change in pain score using FACES pain scale

Time Frame: Through study completion, an average of 4 days.

Change in pain measurement using FACES pain scale from baseline postoperatively until discharge. The scale includes pictures of facial expressions with correlating numerical scale of 0-10, 0 being no hurt and 10 being the worst hurt.

Change in pain score using numeric 0-10 rating scale

Time Frame: Through study completion, an average of 4 days.

Change in pain measurement using standard numeric rating scale from baseline postoperatively until discharge. The numeric rating scale is 0-10 where 0 is no pain, 5 is moderate pain and 10 is the worst pain.

Change in functionality

Time Frame: Through study completion, an average of 4 days.

Change in patient's ability to complete daily functions from baseline postoperatively until discharge. Physical therapy and occupational therapy reports will be reviewed to see if pain appears to interfere with the ability to participate in rehabilitation therapy.

Secondary Outcomes

  • Patient preference for ease of use of the three pain scales (functional, FACES or numerical)(Through study completion, an average of 4 days.)
  • Provider preference for ease of use of the three pain scales (functional, FACES or numerical)(Through study completion, an average of 4 days.)
  • Opioid administration(Through study completion, an average of 4 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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