Pain MeasurementNCT04124289
A Functional Pain Scale to Improve the Patient Experience
An observational study of Pain Measurement, run by The Guthrie Clinic at 1 site in United States.
Trial summary
This will be an observational cohort study to evaluate pain measurement after surgery using a new functional pain scale. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Pain measurement using 3 scales
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 2 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted for orthopedic surgery procedures who will be assessed for pain
Who may be able to join
- 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.
Who cannot join
- Previous diagnosis of cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Pain Measurement
- Being tested
- Pain measurement using 3 scales
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain measurement using 3 scalesOther
Patients will assess their pain after surgery using three different pain scales.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Pain measurement using 3 scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 4 days.
Secondary outcomes (3)
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.
Measured: 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.
Measured: Through study completion, an average of 4 days.
Opioid administration
Dose of opioid administered postoperatively during the hospital stay
Measured: Through study completion, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start29 Oct 2019
- Primary completion21 Jan 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harris W Thomas, BSN, RN-BC, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124289
- Sponsor's protocol ID
- 1906-25
- Status last verified
- Jan 2023
- First submitted
- 5 Sep 2019
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Validate a Functional Pain Scale in Order to Improve the Patient Experience
- ClinicalTrials.gov ID
- NCT04124289
- Acronym / sponsor ID
- 1906-25
- Conditions
- Pain Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain post surgery | – | Other: Pain measurement using 3 scalesPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for orthopedic surgery procedures who will be assessed for pain
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Previous diagnosis of cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain measurement using 3 scalesPatients will assess their pain after surgery using three different pain scales. | Other | Pain post surgery |
Primary outcome
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.
3 secondary outcomes
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.
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.
Opioid administration
Time frame: Through study completion, an average of 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harris W Thomas, BSN, RN-BC principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Measurement, run by The Guthrie Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score using functional pain scale questionnaire (time frame: Through study completion, an average of 4 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.