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Clinical Trials/NCT04124289
NCT04124289
Completed
N/A

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

The Guthrie Clinic1 site in 1 country49 target enrollmentOctober 29, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain Measurement
Sponsor
The Guthrie Clinic
Enrollment
49
Locations
1
Primary Endpoint
Change in pain score using functional pain scale questionnaire
Status
Completed
Last Updated
3 years ago

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).

Registry
clinicaltrials.gov
Start Date
October 29, 2019
End Date
July 2, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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