A Functional Pain Scale to Improve the Patient Experience

Completed

• Conditions: Pain Measurement
• Interventions: Other: Pain measurement using 3 scales

• Registration Number: NCT04124289
• Lead Sponsor: The Guthrie Clinic

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 Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Study Start: 2019-10-29
• Primary Completion: 2020-01-21
• Study Completion: 2020-07-02
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pain post surgery	Pain measurement using 3 scales	Patients who have completed surgery will be assessed with three types of pain scales. A new pain scale, a functional pain scale (FPS), will be compared to two pain scales that are routinely used: the FACES pain scale and the numeric rating scale (NRS).

Primary Outcome Measures

Name	Time	Method
Change in pain score using functional pain scale questionnaire	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	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	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	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 Outcome Measures

Name	Time	Method
Patient preference for ease of use of the three pain scales (functional, FACES or numerical)	Through study completion, an average of 4 days.	Questionnaire: Patient will be asked to answer one question to choose which of the three pain scales they prefer for reporting their level of pain. On a scale of 1 to 3 with 1 being the best for reporting pain, the patient will choose which pain scale they would rank a 1.
Provider preference for ease of use of the three pain scales (functional, FACES or numerical)	Through study completion, an average of 4 days.	Questionnaire: Provider will be asked to answer one question regarding which of the three pain scales they found easiest to complete. On a scale of 1 to 3 with 1 being the best for ease of use, the provider will choose which pain scale they would rank a 1.
Opioid administration	Through study completion, an average of 4 days	Dose of opioid administered postoperatively during the hospital stay

Trial Locations

Locations (1)

Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States