A Functional Pain Scale to Improve the Patient Experience

Pain Measurement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124289
• Other study ID #: 1906-25
• Status: Completed
• Start date: October 29, 2019
• Est. completion date: July 2, 2020

Study information

• Verified date: January 2023
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2, 2020
• Est. primary completion date: January 21, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Measurement

Intervention

Other:
• Pain measurement using 3 scales
Patients will assess their pain after surgery using three different pain scales.

Locations

Country	Name	City	State
United States	Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Opioid administration	Dose of opioid administered postoperatively during the hospital stay	Through study completion, an average of 4 days