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Completed

NCT Number: NCT04124289

A Functional Pain Scale to Improve the Patient Experience

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

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Key information

Conditions

Pain Measurement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain measurement using 3 scales

Other

Patients will assess their pain after surgery using three different pain scales.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  1. Patient preference for ease of use of the three pain scales (functional, FACES or numerical)

    Time frame: 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.

  2. Provider preference for ease of use of the three pain scales (functional, FACES or numerical)

    Time frame: 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.

  3. Opioid administration

    Time frame: Through study completion, an average of 4 days

    Dose of opioid administered postoperatively during the hospital stay

Sponsors and collaborators

Lead sponsor

The Guthrie Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2019
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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