Pain, PostoperativeNCT03714711
Pain Profile and Pain Medication Use After THA and TKA
An observational study of Pain, Postoperative, run by Duke University.
Trial summary
The over-prescription and overuse of opioid medications in the United States has recently been recognized as an epidemic. A new law in North Carolina (STOP Act) is aimed to limit opioid prescriptions following any surgical procedure including total hip (THA) and total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- total hip arthroplasty and total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary total hip or knee arthroplasty
Who may be able to join
- Patients older than 18 years of age undergoing primary total hip or total knee replacement
- Able to give consent to participate in the study
- Patients have a cell phone capable of text messaging
Who cannot join
- Patients from states in the US without a narcotic prescription database (Missouri)
- Patients with previous joint surgery
About this study
Official title: Patient Pain and Opioid Use Profile After Total Hip and Total Knee Arthroplasty
The over-prescription and overuse of opioid medications in the United States has recently been recognized as an epidemic. A new law in North Carolina (STOP Act) is aimed to limit opioid prescriptions following any surgical procedure including total hip (THA) and total knee arthroplasty (TKA). However, there is limited evidence regarding patient's pain and actual opioid consumption following THA and TKA that can be used by practitioners as guidance adapting to the new law. The purpose of this study is to investigate patient's pain and pain medication use in the perioperative period (0-6 weeks) following THA and TKA to establish a pain profile and thereby investigating risk factor for increased postoperative pain and opioid pain medication requirements. This study aims to stratify a predication model of postoperative pain and opioid medication requirement after THA and TKA to identify patients with a high propensity for pain, improve preoperative patient education on postoperative pain expectations, thereby helping practitioners implement new postoperative prescriptions limits for THA and TKA patient.
Read the detailed description
Number of subjects: Patient undergoing THA and TKA will be enrolled in this prospective study. Patients older than 18 years of age, with cell phones capable of text messaging, and who agree to participate in this study will be included. Patients who have their primary residence in Missouri will be excluded from this study due to the lack of a state wide narcotic prescription database in Missouri. Up to 240 patients will be enrolled to reach a minimum of 200 participants (100 THA, 100 TKA patients) with complete data from pre to 1 year postoperatively.
Preoperative questionnaires: Patient will be required to complete a preoperative pain catastrophizing score, abrief pain inventory, EQ-5D, a hip disability and osteoarthritis outcome score (HOOS JR.) or knee injury and osteoarthritis outcome score (KOOS JR.) and aAbaseline pain level on a visual analog scale (0-10) will be recorded.
Preoperative pain medication assessment: Preoperative controlled substance use will be assessed using the patient's state residence Controlled Substance Reporting System. Patient socioeconomic status, prior history of pain medication use, and history of drug abuse will be recorded.
Patient preoperative pain sensitivity testing: Patients will then undergo pain algometer testing (FPK algometer, Wagner Instruments, Greenwich CT) to establish an objective baseline pain tolerance. There is no risk to the patient with algometer testing. Pressure algometer testing will be performed in a standard fashion. The probe is applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds. The participant is instructed by the measurer to say "stop" when the sensation of pressure became the very first sensation of pain. There will be three spots to test patients, one for familiarity of the testing and the other 2 for data collection. This is initially performed once on ipsilateral the tibialis anterior as a "warm up." Then 3 measurements are taken on the operative medial epicondyle (for TKA) or ipsilateral lateral iliac crest (for THA) and averaged for the official score. Lastly, 3 measurements are also taken on the contralateral olecranon to measure systemic pain sensitivity. If the contralateral elbow has had prior surgery or active bursitis, the ipsilateral elbow will be used. Of important note, the algometer has a max force lock out of 100N to prevent any harm to the patient. In addition, we will capture dominant handgrip strength measured by the average of 3 attempts on a standard dynamometer.
In-hospital and postoperative pain and medication assessment: Patient's pain scores on an analog scale will be recorded daily from the patient's electronic medical record (lowest, highest, median) while admitted to the hospital. Patient will be contacted daily via text message to report pain scores and pain medication use. Text messaging via cell phones has become very common in the US and has been shown to be efficacious in obtaining longitudinal research data, specifically in assessing pain scores. Patient will be contacted daily via text messaging (Mosio, Seattle, WA).Mosio is a two-way mobile messaging platform that deploys automated text messages to study subjects. Subjects reply to the questions bv text message which are sent and received through mosio.
The participants will be asked the following questions by text messaging daily:
- What was the average pain level (0-10) in the past 24 hours?
- What was the highest level of satisfaction (0-10) with the total joint in the past 24 hours?
- How many pain medication pills were taken in the past 24 hours?
The responses by the patient are replied to and typed as a standard text message. The answers will be captured by mosio and transferred in the secure database. The study team has instant access to the data server via secured log in authentication. Study replies can be downloaded as excel spreadsheets for further analysis.
At the standard of care 6-week and 1-year postoperative visit, participants will complete a Visual Analog Scale (VAS), PROMIS pain scale, EQ-5D and HOOS JR or KOOS JR questionnaire. Once questionnaires are completed this will conclude study participation.
- Conditions
- Pain, Postoperative
- Being tested
- total hip arthroplasty, total knee arthroplasty
- Keywords
- total hip replacement, total knee replacement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplastyProcedure or surgery
Total hip replacement
total knee arthroplastyProcedure or surgery
Total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| Total hip arthroplasty | Patient who are scheduled to undergo total hip replacement. Receives: Procedure: total hip arthroplasty | |
| Total knee arthroplasty | Patient who are scheduled to undergo total knee replacement. Receives: Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Pain level
Change in Patients' pain level on visual analog scale from 0-10; 0 no pain, 10 worst pain imaginable
Measured: 1 - 6 weeks on average
Secondary outcomes (12)
Change in opioid consumption
Change in patient use of opioid pain medication
Measured: daily for 6 weeks after surgery
Change in satisfaction level
Change in patient satisfaction with total joint replacement, scale 0-10; 0 no satisfaction, 10, highest satisfaction possible
Measured: daily for 6 weeks after surgery
EQ5D
Health related quality of life; scale of 0-100, 0 worst health imaginable, 100 best health imaginable
Measured: Once before surgery, up to 10 minutes
EQ5D
Health related quality of life; scale of 0-100, 0 worst health imaginable, 100 best health imaginable
Measured: 6 weeks postoperative
EQ5D
Health related quality of life; scale of 0-100, 0 worst health imaginable, 100 best health imaginable
Measured: 1 year postoperative
hip disability and osteoarthritis outcome score (HOOS)
Total hip replacement clinic outcome measure; scale from 0-100; 0 total hip disability, 100 perfect hip health
Measured: Once before surgery, up to 10 minutes
hip disability and osteoarthritis outcome score
Total hip replacement clinic outcome measure; scale from 0-100; 0 total hip disability, 100 perfect hip health
Measured: 6 weeks postoperative
hip disability and osteoarthritis outcome score
Total hip replacement clinic outcome measure; scale from 0-100; 0 total hip disability, 100 perfect hip health
Measured: 1 year postoperative
knee disability and osteoarthritis outcome score
Total knee replacement clinic outcome measure; scale from 0-100; 0 total knee disability, 100 perfect knee health
Measured: Once before surgery, up to 10 minutes
knee disability and osteoarthritis outcome score
Total knee replacement clinic outcome measure; scale from 0-100; 0 total knee disability, 100 perfect knee health
Measured: 6 weeks postoperative
knee disability and osteoarthritis outcome score
Total knee replacement clinic outcome measure; scale from 0-100; 0 total knee disability, 100 perfect knee health
Measured: 1 year postoperative
Pain threshold
Pressure algometer testing
Measured: Preoperative clinic visit, up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: PI decided to close due to current funding and future funding constraints on internal studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thorsten Seyler, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714711
- Sponsor's protocol ID
- Pro00100351
- Status last verified
- Jun 2025
- First submitted
- 24 Sep 2018
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Pain and Opioid Use Profile After Total Hip and Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03714711
- Acronym / sponsor ID
- Pro00100351
- Conditions
- Pain, Postoperative
- Keywords
- total hip replacement, total knee replacement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decided to close due to current funding and future funding constraints on internal studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Oct 2018 (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.
The over-prescription and overuse of opioid medications in the United States has recently been recognized as an epidemic. A new law in North Carolina (STOP Act) is aimed to limit opioid prescriptions following any surgical procedure including total hip (THA) and total knee arthroplasty (TKA). However, there is limited evidence regarding patient's pain and actual opioid consumption following THA and TKA that can be used by practitioners as guidance adapting to the new law. The purpose of this study is to investigate patient's pain and pain medication use in the perioperative period (0-6 weeks) following THA and TKA to establish a pain profile and thereby investigating risk factor for increased postoperative pain and opioid pain medication requirements. This study aims to stratify a predication model of postoperative pain and opioid medication requirement after THA and TKA to identify patients with a high propensity for pain, improve preoperative patient education on postoperative pain expectations, thereby helping practitioners implement new postoperative prescriptions limits for THA and TKA patient.
Detailed description
Number of subjects: Patient undergoing THA and TKA will be enrolled in this prospective study. Patients older than 18 years of age, with cell phones capable of text messaging, and who agree to participate in this study will be included. Patients who have their primary residence in Missouri will be excluded from this study due to the lack of a state wide narcotic prescription database in Missouri. Up to 240 patients will be enrolled to reach a minimum of 200 participants (100 THA, 100 TKA patients) with complete data from pre to 1 year postoperatively.
Preoperative questionnaires: Patient will be required to complete a preoperative pain catastrophizing score, abrief pain inventory, EQ-5D, a hip disability and osteoarthritis outcome score (HOOS JR.) or knee injury and osteoarthritis outcome score (KOOS JR.) and aAbaseline pain level on a visual analog scale (0-10) will be recorded.
Preoperative pain medication assessment: Preoperative controlled substance use will be assessed using the patient's state residence Controlled Substance Reporting System. Patient socioeconomic status, prior history of pain medication use, and history of drug abuse will be recorded.
Patient preoperative pain sensitivity testing: Patients will then undergo pain algometer testing (FPK algometer, Wagner Instruments, Greenwich CT) to establish an objective baseline pain tolerance. There is no risk to the patient with algometer testing. Pressure algometer testing will be performed in a standard fashion. The probe is applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds. The participant is instructed by the measurer to say "stop" when the sensation of pressure became the very first sensation of pain. There will be three spots to test patients, one for familiarity of the testing and the other 2 for data collection. This is initially performed once on ipsilateral the tibialis anterior as a "warm up." Then 3 measurements are taken on the operative medial epicondyle (for TKA) or ipsilateral lateral iliac crest (for THA) and averaged for the official score. Lastly, 3 measurements are also taken on the contralateral olecranon to measure systemic pain sensitivity. If the contralateral elbow has had prior surgery or active bursitis, the ipsilateral elbow will be used. Of important note, the algometer has a max force lock out of 100N to prevent any harm to the patient. In addition, we will capture dominant handgrip strength measured by the average of 3 attempts on a standard dynamometer.
In-hospital and postoperative pain and medication assessment: Patient's pain scores on an analog scale will be recorded daily from the patient's electronic medical record (lowest, highest, median) while admitted to the hospital. Patient will be contacted daily via text message to report pain scores and pain medication use. Text messaging via cell phones has become very common in the US and has been shown to be efficacious in obtaining longitudinal research data, specifically in assessing pain scores. Patient will be contacted daily via text messaging (Mosio, Seattle, WA).Mosio is a two-way mobile messaging platform that deploys automated text messages to study subjects. Subjects reply to the questions bv text message which are sent and received through mosio.
The participants will be asked the following questions by text messaging daily:
- What was the average pain level (0-10) in the past 24 hours?
- What was the highest level of satisfaction (0-10) with the total joint in the past 24 hours?
- How many pain medication pills were taken in the past 24 hours?
The responses by the patient are replied to and typed as a standard text message. The answers will be captured by mosio and transferred in the secure database. The study team has instant access to the data server via secured log in authentication. Study replies can be downloaded as excel spreadsheets for further analysis.
At the standard of care 6-week and 1-year postoperative visit, participants will complete a Visual Analog Scale (VAS), PROMIS pain scale, EQ-5D and HOOS JR or KOOS JR questionnaire. Once questionnaires are completed this will conclude study participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total hip arthroplasty | – | Procedure: total hip arthroplastyPatient who are scheduled to undergo total hip replacement. |
| Total knee arthroplasty | – | Procedure: total knee arthroplastyPatient who are scheduled to undergo total knee replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary total hip or knee arthroplasty
Key inclusion criteria (3 listed)
- Patients older than 18 years of age undergoing primary total hip or total knee replacement
- Able to give consent to participate in the study
- Patients have a cell phone capable of text messaging
Key exclusion criteria (2 listed)
- Patients from states in the US without a narcotic prescription database (Missouri)
- Patients with previous joint surgery
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 |
|---|---|---|
| total hip arthroplastyTotal hip replacement | Procedure or surgery | Total hip arthroplasty |
| total knee arthroplastyTotal knee replacement | Procedure or surgery | Total knee arthroplasty |
Primary outcome
Change in Patient Pain level
Time frame: 1 - 6 weeks on average
Change in Patients' pain level on visual analog scale from 0-10; 0 no pain, 10 worst pain imaginable
12 secondary outcomes
Change in opioid consumption
Time frame: daily for 6 weeks after surgery
Change in satisfaction level
Time frame: daily for 6 weeks after surgery
EQ5D
Time frame: Once before surgery, up to 10 minutes
EQ5D
Time frame: 6 weeks postoperative
EQ5D
Time frame: 1 year postoperative
hip disability and osteoarthritis outcome score (HOOS)
Time frame: Once before surgery, up to 10 minutes
hip disability and osteoarthritis outcome score
Time frame: 6 weeks postoperative
hip disability and osteoarthritis outcome score
Time frame: 1 year postoperative
knee disability and osteoarthritis outcome score
Time frame: Once before surgery, up to 10 minutes
knee disability and osteoarthritis outcome score
Time frame: 6 weeks postoperative
knee disability and osteoarthritis outcome score
Time frame: 1 year postoperative
Pain threshold
Time frame: Preoperative clinic visit, up to 10 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- 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.
Thorsten Seyler, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Duke University.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Patient Pain level (time frame: 1 - 6 weeks on average). 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 15 Jun 2025.