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Total Knee ReplacementNCT03961152

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

A study testing PainCoach app in people with Total Knee Replacement and Pain, run by Kliniek ViaSana at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Total Knee Replacement, Pain, Opioid Use
What is being tested?
PainCoach app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteNetherlands
Study dates
15 Jan 2016to 8 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Planned for primary TKR

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Kliniek ViaSana

    Mill

Other trials in Netherlands

About this study

Official title: 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.

Being tested
PainCoach app
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PainCoach appBehavioural

    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.

Study groups in NCT03961152
Study groupRoleWhat they receive
PainCoach-app groupExperimentalIn 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.
Receives: Behavioral: PainCoach app
Control groupNo interventionThe control group received usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 14 measurement points: daily from day 1 to 14 after surgery

  2. 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)

    Measured: 14 measurement points: daily from day 1 to 14 after surgery

  3. 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)

    Measured: 14 measurement points: daily from day 1 to 14 after surgery

  4. 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

    Measured: 14 measurement points: daily from day 1 to 14 after surgery

Secondary outcomes (11)

  1. Pain at rest

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

    Measured: 1 month after surgery

  2. Pain during activity

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

    Measured: 1 month after surgery

  3. Pain at night

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

    Measured: 1 month after surgery

  4. 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

    Measured: 14 measurement points: daily from day 1 to 14 after surgery

  5. 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)

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

  6. 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

    Measured: 14 measurement points: daily from day 1 to 14 after surgery

  7. 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)

    Measured: 1 month after surgery

  8. Function and pain

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

    Measured: 1 month after surgery

  9. 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).

    Measured: 1 month after surgery

  10. 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

    Measured: Day 14 after surgery

  11. Active PainCoach app use

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

    Measured: From day 1 to 14 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2019
  2. Study start15 Jan 2016
  3. Primary completion6 Jul 2016
  4. Study completion8 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961152
Sponsor's protocol ID
PainCoach app study
Status last verified
May 2019
First submitted
14 May 2019
Last updated
23 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32167483

Questions about this trial

What is this clinical trial studying?

A study testing PainCoach app in people with Total Knee Replacement and Pain, run by Kliniek ViaSana at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03961152, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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