A Functional Pain Scale to Improve the Patient Experience

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

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

Study Overview

• Status: Completed
• Conditions: Pain Measurement
• Intervention / Treatment: Other: Pain measurement using 3 scales

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 Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

• Study Contact: Name: Harris W Thomas, BSN, RN-BC; Phone Number: 570-887-5251; Email: Harris.Thomas@guthrie.org
• Study Contact Backup: Name: Lee Holman, BSN, RN-ONC; Phone Number: 570-887-5966; Email: Lee.Holman@guthrie.org

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for orthopedic surgery procedures who will be assessed for pain

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pain post surgery; 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).	Other: Pain measurement using 3 scales; Patients will assess their pain after surgery using three different pain scales.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain score using functional pain scale questionnaire	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	Through study completion, an average of 4 days.
Change in pain score using FACES pain scale	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.	Through study completion, an average of 4 days.
Change in pain score using numeric 0-10 rating scale	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.	Through study completion, an average of 4 days.
Change in functionality	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.	Through study completion, an average of 4 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preference for ease of use of the three pain scales (functional, FACES or numerical)	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.	Through study completion, an average of 4 days.
Provider preference for ease of use of the three pain scales (functional, FACES or numerical)	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.	Through study completion, an average of 4 days.
Opioid administration	Dose of opioid administered postoperatively during the hospital stay	Through study completion, an average of 4 days

Collaborators and Investigators

• Sponsor: The Guthrie Clinic
• Investigators: Principal Investigator: Harris W Thomas, BSN, RN-BC, The Guthrie Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Actual): January 21, 2020
• Study Completion (Actual): July 2, 2020

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1906-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No