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Pain, PostoperativeNCT03714711

Pain Profile and Pain Medication Use After THA and TKA

An observational study of Pain, Postoperative, run by Duke University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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:

  1. What was the average pain level (0-10) in the past 24 hours?
  2. What was the highest level of satisfaction (0-10) with the total joint in the past 24 hours?
  3. 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.

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 groups in NCT03714711
Study groupRoleWhat they receive
Total hip arthroplastyPatient who are scheduled to undergo total hip replacement.
Receives: Procedure: total hip arthroplasty
Total knee arthroplastyPatient 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.

  1. 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)
  1. Change in opioid consumption

    Change in patient use of opioid pain medication

    Measured: daily for 6 weeks after surgery

  2. 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

  3. 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

  4. EQ5D

    Health related quality of life; scale of 0-100, 0 worst health imaginable, 100 best health imaginable

    Measured: 6 weeks postoperative

  5. EQ5D

    Health related quality of life; scale of 0-100, 0 worst health imaginable, 100 best health imaginable

    Measured: 1 year postoperative

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted22 Oct 2018
  2. Study startAug 2025 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Why it stopped: PI decided to close due to current funding and future funding constraints on internal studies.

Resources

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)
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

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.

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