Clinical trial NCT03961152: Effect of the PainCoach App on Pain and Opiate Use After Total Knee Replacement
Official title: Effect of the PainCoach App on Pain and Opiate Use in the First Two Weeks After Total Knee Replacement: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Pain
Opioid Use
E-health App
Lead sponsor: Kliniek ViaSana
Sponsor class: OTHER
Collaborators: name: St. Anna Ziekenhuis, Geldrop, Netherlands
First posted: 2019-05-23
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in pain at rest in the first two weeks at home after TKR
timeFrame: 14 measurement points: daily from day 1 to 14 after surgery
measure: Change in pain during activity in the first two weeks at home after TKR
timeFrame: 14 measurement points: daily from day 1 to 14 after surgery
measure: Change in pain at night in the first two weeks at home after TKR
timeFrame: 14 measurement points: daily from day 1 to 14 after surgery
measure: Change in opiate use in the first two weeks at home after TKR
timeFrame: 14 measurement points: daily from day 1 to 14 after surgery
Secondary outcomes:
measure: Pain at rest
timeFrame: 1 month after surgery
measure: Pain during activity
timeFrame: 1 month after surgery
measure: Pain at night
timeFrame: 1 month after surgery
measure: Change in other pain medication use in the first two weeks at home after TKR
timeFrame: 14 measurement points: daily from day 1 to 14 after surgery
measure: Change in pain acceptance at rest, during activity and at night in the first two weeks at home after TKR
timeFrame: 14 measurement points: daily from day 1 to 14, and at 1 month after surgery
measure: Change in experiences with the executed recommended physiotherapy exercises in the first two weeks at home after TKR
timeFrame: 14 measurement points: daily from day 1 to 14 after surgery
measure: Function
timeFrame: 1 month after surgery
measure: Function and pain
timeFrame: 1 month after surgery
measure: Quality of life
timeFrame: 1 month after surgery
measure: PainCoach app's perceived effectiveness
timeFrame: Day 14 after surgery
measure: Active PainCoach app use
timeFrame: From day 1 to 14 after surgery
Other outcomes:
Locations:
city: Mill
country: Netherlands
facility: Kliniek ViaSana
Study officials:
affiliation: Kliniek ViaSana
name: J.M. Brinkman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.