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Preoperative Pain Threshold and Rapid Recover Programs

Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02740738
Enrollment
201
Registered
2016-04-15
Start date
2016-03-31
Completion date
2018-08-06
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthritis, Hip Arthritis

Keywords

Knee Arthroplasty, Hip Arthroplasty

Brief summary

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. 1. This is initially performed once on ipsilateral the tibialis anterior as a warm up. 2. 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. 3. 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. 4. 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: 1. How many and what kind of opiates did the participant require? 2. How many days did the participant require opiates? 3. 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?

Interventions

DEVICEWagner Pain Algometer

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

Dominant Hand Grip strength measured by the average of 3 attempts

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* previous hip or knee surgery in the operative joint

Design outcomes

Primary

MeasureTime frameDescription
physical therapy performance on the first day after surgerypost op day 1distance walked in feet on post op day 1
Inpatient length of stay in days1-3 on days averageamount of time in hospital
pain control average visual analogue scale 1 - 10 of hospital stay1-3 days on averageaveraging the subjective pain control
discharge location placement1 - 3 days on averagehome, rehab or nursing facility

Secondary

MeasureTime frameDescription
Outpatient narcotic consumption multiple refills needed6-week from surgerynumber of refills needed requiring provider time outside of scheduled appointment
Outpatient narcotic consumption refill needed6-week from surgeryneed for refill prescription, yes or no
Outpatient narcotic pill consumption6-week from surgerynarcotic equivalents consumed by patient in morphine equivalents. we will convert all medicine to the standard unit

Other

MeasureTime frameDescription
Complications short term after surgery6-week from surgeryInpatient complications while in the hospital
Complications long term after surgerysurgery to 1yr postoperativeOutpatient complications seen after discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026