E-health App, Opioid Use, Pain, Total Knee Replacement
Conditions
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.
Interventions
BEHAVIORALPainCoach 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.
Sponsors
St. Anna Ziekenhuis, Geldrop, Netherlands
Kliniek ViaSana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain at rest in the first two weeks at home after TKR | 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) |
| Change in pain during activity in the first two weeks at home after TKR | 14 measurement points: daily from day 1 to 14 after surgery | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) |
| Change in pain at night in the first two weeks at home after TKR | 14 measurement points: daily from day 1 to 14 after surgery | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) |
| Change in opiate use in the first two weeks at home after TKR | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain acceptance at rest, during activity and at night in the first two weeks at home after TKR | 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) |
| Change in experiences with the executed recommended physiotherapy exercises in the first two weeks at home after TKR | 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 |
| Function | 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) |
| Pain at rest | 1 month after surgery | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) |
| Quality of life | 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). |
| PainCoach app's perceived effectiveness | 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 |
| Active PainCoach app use | 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 |
| Function and pain | 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) |
| Pain during activity | 1 month after surgery | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) |
| Pain at night | 1 month after surgery | Measured with VAS from 0 (no pain) to 100 (worst imaginable pain) |
| Change in other pain medication use in the first two weeks at home after TKR | 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 |
Countries
Netherlands
Outcome results
None listed