Skip to main content
OpenTrials
Completed

NCT Number: NCT03961152

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Knee Replacement E-health App Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniek ViaSana

Mill, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PainCoach app

Behavioral

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.

Primary outcomes

  1. Change in pain at rest in the first two weeks at home after TKR

    Time frame: 14 measurement points: daily from day 1 to 14 after surgery

    Pain at rest was daily measured with VAS from 0 (no pain) to 100 (worst imaginable pain)

  2. Change in pain during activity in the first two weeks at home after TKR

    Time frame: 14 measurement points: daily from day 1 to 14 after surgery

    Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)

  3. Change in pain at night in the first two weeks at home after TKR

    Time frame: 14 measurement points: daily from day 1 to 14 after surgery

    Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)

  4. Change in opiate use in the first two weeks at home after TKR

    Time frame: 14 measurement points: daily from day 1 to 14 after surgery

    Oxycodon (5 mg per tablet) use was recorded in quantities per 24 hours

Secondary outcomes

  1. Pain at rest

    Time frame: 1 month after surgery

    Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)

  2. Pain during activity

    Time frame: 1 month after surgery

    Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)

  3. Pain at night

    Time frame: 1 month after surgery

    Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)

  4. Change in other pain medication use in the first two weeks at home after TKR

    Time frame: 14 measurement points: daily from day 1 to 14 after surgery

    i.e. NSAID (Diclofenac), acetaminophen and/or Gabapentin were recorded in quantities per 24 hours

  5. Change in pain acceptance at rest, during activity and at night in the first two weeks at home after TKR

    Time frame: 14 measurement points: daily from day 1 to 14, and at 1 month after surgery

    Measured with a happy smiley (acceptable pain) and a sad smiley (unacceptable pain)

  6. Change in experiences with the executed recommended physiotherapy exercises in the first two weeks at home after TKR

    Time frame: 14 measurement points: daily from day 1 to 14 after surgery

    Measured on a 3-item scale; did too much, exactly enough, or could have done more exercises

  7. Function

    Time frame: 1 month after surgery

    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)

  8. Function and pain

    Time frame: 1 month after surgery

    Measured with the Oxford Knee Score (OKS) with a total score from 0 (most severe symptoms) to 48 (least severe symptoms)

  9. Quality of life

    Time frame: 1 month after surgery

    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).

  10. PainCoach app's perceived effectiveness

    Time frame: Day 14 after surgery

    Usability, added value, and likelihood of being recommended to others was recorded on a 5-item scale ranging from totally agree to totally disagree

  11. Active PainCoach app use

    Time frame: From day 1 to 14 after surgery

    Measured with recording the actual amount of app use and defining active use as at least 12 times in total

Sponsors and collaborators

Lead sponsor

Kliniek ViaSana

Other

Collaborators

  • St. Anna Ziekenhuis, Geldrop, Netherlands

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 23, 2019
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.