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

NCT03961152 | Completed

• 1 other identifier: PainCoach app study
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (11)

• Pain at rest

  1 month after surgery

• Pain during activity

  1 month after surgery

• Pain at night

  1 month after surgery

• 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

• 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

Study Arms (2)

PainCoach-app group

EXPERIMENTAL

In 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.

Behavioral: PainCoach app

Control group

NO INTERVENTION

The control group received usual care.

Interventions

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.

PainCoach-app group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for primary TKR

You may not qualify if:

• 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

Sponsors & Collaborators

• Kliniek ViaSana: lead
• St. Anna Ziekenhuis, Geldrop, Netherlands: collaborator

Study Sites (1)

Kliniek ViaSana

Mill, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 32167483 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• J.M. Brinkman, MD, PhD

  Kliniek ViaSana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 23, 2019
• Study Start: January 15, 2016
• Primary Completion: July 6, 2016
• Study Completion: June 8, 2017
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)