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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Opioid Use; Total Knee Replacement; E-health App
• Intervention / Treatment: Behavioral: PainCoach app

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Mill, Netherlands
    • Kliniek ViaSana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PainCoach-app group; 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; 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.
No Intervention: Control group; 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

Collaborators and Investigators

• Sponsor: Kliniek ViaSana
• Collaborators: St. Anna Ziekenhuis, Geldrop, Netherlands
• Investigators: Principal Investigator: J.M. Brinkman, MD, PhD, Kliniek ViaSana

Publications and helpful links

General Publications

• Pronk Y, Peters MCWM, Sheombar A, Brinkman JM. Effectiveness of a Mobile eHealth App in Guiding Patients in Pain Control and Opiate Use After Total Knee Replacement: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 13;8(3):e16415. doi: 10.2196/16415.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Actual): July 6, 2016
• Study Completion (Actual): June 8, 2017

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PainCoach app study

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