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

May 22, 2019 updated by: Kliniek ViaSana

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PainCoach-app group
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
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.
No Intervention: Control group
The control group received usual care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
14 measurement points: daily from day 1 to 14 after surgery
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
14 measurement points: daily from day 1 to 14 after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain at rest
Time Frame: 1 month after surgery
Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
1 month after surgery
Pain during activity
Time Frame: 1 month after surgery
Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
1 month after surgery
Pain at night
Time Frame: 1 month after surgery
Measured with VAS from 0 (no pain) to 100 (worst imaginable pain)
1 month after surgery
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
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
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)
14 measurement points: daily from day 1 to 14, and at 1 month after surgery
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
14 measurement points: daily from day 1 to 14 after surgery
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)
1 month after surgery
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)
1 month after surgery
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).
1 month after surgery
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
Day 14 after surgery
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
From day 1 to 14 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kliniek ViaSana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
St. Anna Ziekenhuis, Geldrop, Netherlands

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J.M. Brinkman, MD, PhD, Kliniek ViaSana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PainCoach app study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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