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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02740738
Other study ID # Pro00069521
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date August 6, 2018

Study information

Verified date April 2019
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.


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?


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date August 6, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Wagner 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
Dynamometer
Dominant Hand Grip strength measured by the average of 3 attempts

Locations

Country Name City State
United States Duke Medical Plaza Page Road Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Complications short term after surgery Inpatient complications while in the hospital 6-week from surgery
Other Complications long term after surgery Outpatient complications seen after discharge surgery to 1yr postoperative
Primary Inpatient length of stay in days amount of time in hospital 1-3 on days average
Primary pain control average visual analogue scale 1 - 10 of hospital stay averaging the subjective pain control 1-3 days on average
Primary physical therapy performance on the first day after surgery distance walked in feet on post op day 1 post op day 1
Primary discharge location placement home, rehab or nursing facility 1 - 3 days on average
Secondary 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
Secondary Outpatient narcotic consumption refill needed need for refill prescription, yes or no 6-week from surgery
Secondary Outpatient narcotic consumption multiple refills needed number of refills needed requiring provider time outside of scheduled appointment 6-week from surgery
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