Knee ArthritisNCT02740738
Preoperative Pain Threshold and Rapid Recover Programs
A study testing Wagner Pain Algometer and Dynamometer in people with Knee Arthritis and Hip Arthritis, run by Duke University at 1 site in United States.
Trial summary
To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Arthritis, Hip Arthritis
- What is being tested?
- Wagner Pain Algometer and Dynamometer
- Type of treatment
- Medical device
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 6 Aug 2018
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty
- Participants of the following investigators will be approached: Bolognesi, Wellman, Attarian, and Seyler
Who cannot join
- previous hip or knee surgery in the operative joint
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Medical Plaza Page Road
Durham, North Carolina, 27703
About this study
Official title: Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty
To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.
Read the detailed description
A minimum of 200 patients, 100 hip and 100 knee arthroplasty participants, will be recruited for this study. Preoperatively, patient pain threshold will be recorded both objectively (Pressure algometer) and subjectively (brief pain inventory). In terms of location, objectively this will be tested during the preoperative visit in clinic by the approved, trained research staff, as well as the subjective brief pain inventory.
Objective pain measure: Pressure algometer will be obtained in the standard fashion as follows: 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, three 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.
- Dominant Hand Grip strength measured by the average of 3 attempts on a Dynamometer.
Subjectively, the brief pain inventory is a validated pain outcome measure which will be filled out by the participant during their preoperative clinic visit.
Postoperative, the study team will ask the participant at the 6 week mark:
- How many and what kind of opiates did the participant require?
- How many days did the participant require opiates?
- Did the participant require a refill? a. If so, did the participant have this filled in clinic preemptively or place a phone call to the office?
- Conditions
- Knee Arthritis, Hip Arthritis
- Being tested
- Wagner Pain Algometer, Dynamometer
- Keywords
- Knee Arthroplasty, Hip Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wagner Pain AlgometerDevice
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
DynamometerDevice
Dominant Hand Grip strength measured by the average of 3 attempts
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient length of stay in days
amount of time in hospital
Measured: 1-3 on days average
pain control average visual analogue scale 1 - 10 of hospital stay
averaging the subjective pain control
Measured: 1-3 days on average
physical therapy performance on the first day after surgery
distance walked in feet on post op day 1
Measured: post op day 1
discharge location placement
home, rehab or nursing facility
Measured: 1 - 3 days on average
Secondary outcomes (3)
Outpatient narcotic pill consumption
narcotic equivalents consumed by patient in morphine equivalents. we will convert all medicine to the standard unit
Measured: 6-week from surgery
Outpatient narcotic consumption refill needed
need for refill prescription, yes or no
Measured: 6-week from surgery
Outpatient narcotic consumption multiple refills needed
number of refills needed requiring provider time outside of scheduled appointment
Measured: 6-week from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion30 Jun 2018
- Study completion6 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Wellman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740738
- Sponsor's protocol ID
- Pro00069521
- Status last verified
- Apr 2019
- First submitted
- 16 Mar 2016
- Last updated
- 8 Apr 2019
- 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 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT02740738
- Acronym / sponsor ID
- Pro00069521
- Conditions
- Knee Arthritis, Hip Arthritis
- Keywords
- Knee Arthroplasty, Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.
Detailed description
A minimum of 200 patients, 100 hip and 100 knee arthroplasty participants, will be recruited for this study. Preoperatively, patient pain threshold will be recorded both objectively (Pressure algometer) and subjectively (brief pain inventory). In terms of location, objectively this will be tested during the preoperative visit in clinic by the approved, trained research staff, as well as the subjective brief pain inventory.
Objective pain measure: Pressure algometer will be obtained in the standard fashion as follows: 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, three 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.
- Dominant Hand Grip strength measured by the average of 3 attempts on a Dynamometer.
Subjectively, the brief pain inventory is a validated pain outcome measure which will be filled out by the participant during their preoperative clinic visit.
Postoperative, the study team will ask the participant at the 6 week mark:
- How many and what kind of opiates did the participant require?
- How many days did the participant require opiates?
- Did the participant require a refill? a. If so, did the participant have this filled in clinic preemptively or place a phone call to the office?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty
- Participants of the following investigators will be approached: Bolognesi, Wellman, Attarian, and Seyler
Key exclusion criteria (1 listed)
- previous hip or knee surgery in the operative joint
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 |
|---|---|---|
| Wagner Pain Algometerapplied 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 | Device | – |
| DynamometerDominant Hand Grip strength measured by the average of 3 attempts | Device | – |
Primary outcome
Inpatient length of stay in days
Time frame: 1-3 on days average
amount of time in hospital
pain control average visual analogue scale 1 - 10 of hospital stay
Time frame: 1-3 days on average
averaging the subjective pain control
physical therapy performance on the first day after surgery
Time frame: post op day 1
distance walked in feet on post op day 1
discharge location placement
Time frame: 1 - 3 days on average
home, rehab or nursing facility
3 secondary outcomes
Outpatient narcotic pill consumption
Time frame: 6-week from surgery
Outpatient narcotic consumption refill needed
Time frame: 6-week from surgery
Outpatient narcotic consumption multiple refills needed
Time frame: 6-week from surgery
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 8 Apr 2019.
- 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.
Samuel Wellman, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wagner Pain Algometer and Dynamometer in people with Knee Arthritis and Hip Arthritis, run by Duke University 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 2 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 8 Apr 2019. 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?
Inpatient length of stay in days (time frame: 1-3 on days average). 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 8 Apr 2019.