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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961152
• Other study ID #: PainCoach app study
• Status: Completed
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: June 8, 2017

Study information

• Verified date: May 2019
• Source: Kliniek ViaSana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 8, 2017
• Est. primary completion date: July 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• E-health App
• Opioid Use
• Pain
• Total Knee Replacement

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Kliniek ViaSana	Mill

Sponsors (2)

Lead Sponsor	Collaborator
Kliniek ViaSana	St. Anna Ziekenhuis, Geldrop, Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Pain at rest	Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)	1 month after surgery
Secondary	Pain during activity	Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)	1 month after surgery
Secondary	Pain at night	Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)	1 month after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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