Effect of the PainCoach App on Pain and Opiate Use After Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Less is known about pain and opiate use at home directly after total knee replacement (TKR). Regarding side effects, low opiate use is desired. An e-health application, PainCoach app, was developed to guide patients in pain control and opiate use. The aim of this study was to investigate the effect of the PainCoach app on pain and opiate use in TKR patients in the first two weeks at home after surgery. The hypothesis was that the use of this app would decrease pain and opiate use.

Official Title
-----------------
Effect of the PainCoach App on Pain and Opiate Use in the First Two Weeks After Total Knee Replacement: Randomised Controlled Trial

Conditions
-----------------
Total Knee Replacement, Pain, Opioid Use, E-health App

Intervention / Treatment
-----------------
* Behavioral: PainCoach app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned for primary TKR Exclusion Criteria: No possession of a smartphone or tablet Contra-indication to any of the pain medication used in the study No email address No internet at home No thorough command of the Dutch language Suffering from memory disorders Surgery under general anaesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomised to the PainCoach-app group or control group. Both groups received usual care. In the PainCoach-app group, in addition to receiving the aforementioned usual care, patients could use the PainCoach app whenever they wanted. In response to the patient's input of the pain experienced, the app gave advice on pain medication use, exercises/rest and when to call the clinic. This advice was the same as patients also received during usual care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PainCoach-app group<br>In the PainCoach-app group, in addition to receiving the aforementioned usual care, the PainCoach app was downloaded on each patient's smartphone or tablet. Patients could use this app whenever they wanted until day 14 after surgery. They were not subjected to any different treatment compared to the control group, i.e. advice on pain management was delivered in an extra and different way, but the pain medication itself was exactly the same for both groups. | Behavioral: PainCoach app<br>* In response to the patient's input of the pain experienced (no pain, bearable pain, unbearable pain, or untenable pain), the app gave advice on pain medication use, exercises/rest and when to call the clinic from day 1 until day 14 after surgery.<br>|
| No Intervention: Control group<br>The control group received usual care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain at rest in the first two weeks at home after TKR | Pain at rest was daily measured with VAS from 0 (no pain) to 100 (worst imaginable pain) | 14 measurement points: daily from day 1 to 14 after surgery | 
| Change in pain during activity in the first two weeks at home after TKR | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) | 14 measurement points: daily from day 1 to 14 after surgery | 
| Change in pain at night in the first two weeks at home after TKR | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) | 14 measurement points: daily from day 1 to 14 after surgery | 
| Change in opiate use in the first two weeks at home after TKR | Oxycodon (5 mg per tablet) use was recorded in quantities per 24 hours | 14 measurement points: daily from day 1 to 14 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) | 1 month after surgery | 
| Pain during activity | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) | 1 month after surgery | 
| Pain at night | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) | 1 month after surgery | 
| Change in other pain medication use in the first two weeks at home after TKR | i.e. NSAID (Diclofenac), acetaminophen and/or Gabapentin were recorded in quantities per 24 hours | 14 measurement points: daily from day 1 to 14 after surgery | 
| Change in pain acceptance at rest, during activity and at night in the first two weeks at home after TKR | Measured with a happy smiley (acceptable pain) and a sad smiley (unacceptable pain) | 14 measurement points: daily from day 1 to 14, and at 1 month after surgery | 
| Change in experiences with the executed recommended physiotherapy exercises in the first two weeks at home after TKR | Measured on a 3-item scale; did too much, exactly enough, or could have done more exercises | 14 measurement points: daily from day 1 to 14 after surgery | 
| Function | Measured with the Knee injury and Osteoarthritis Outcome Score - Physical Function Short-form (KOOS-PS) with a total score from 0 (no difficulty) to 100 (extreme difficulty) | 1 month after surgery | 
| Function and pain | Measured with the Oxford Knee Score (OKS) with a total score from 0 (most severe symptoms) to 48 (least severe symptoms) | 1 month after surgery | 
| Quality of life | Measured with the EuroQol-5D 3 level version (EQ-5D-3L) consisting of two scores: EQ Visual Analogue Scale (EQ VAS) score from 0 (worst imaginable health state) to 100 (best imaginable health state), and EQ-5D descriptive system (EQ-5D index). | 1 month after surgery | 
| PainCoach app's perceived effectiveness | Usability, added value, and likelihood of being recommended to others was recorded on a 5-item scale ranging from totally agree to totally disagree | Day 14 after surgery | 
| Active PainCoach app use | Measured with recording the actual amount of app use and defining active use as at least 12 times in total | From day 1 to 14 after surgery |