Preoperative Pain Threshold and Rapid Recover Programs

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthritis; Hip Arthritis
• Intervention / Treatment: Device: Wagner Pain Algometer; Device: Dynamometer

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?

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke Medical Plaza Page Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inpatient length of stay in days	amount of time in hospital	1-3 on days average
pain control average visual analogue scale 1 - 10 of hospital stay	averaging the subjective pain control	1-3 days on average
physical therapy performance on the first day after surgery	distance walked in feet on post op day 1	post op day 1
discharge location placement	home, rehab or nursing facility	1 - 3 days on average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outpatient narcotic pill consumption	narcotic equivalents consumed by patient in morphine equivalents. we will convert all medicine to the standard unit	6-week from surgery
Outpatient narcotic consumption refill needed	need for refill prescription, yes or no	6-week from surgery
Outpatient narcotic consumption multiple refills needed	number of refills needed requiring provider time outside of scheduled appointment	6-week from surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications short term after surgery	Inpatient complications while in the hospital	6-week from surgery
Complications long term after surgery	Outpatient complications seen after discharge	surgery to 1yr postoperative

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 6, 2018

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Knee Arthroplasty; Hip Arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: Pro00069521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No