Living Well with Chronic Pain

NCT ID: NCT03705104

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2030-01-31

Brief Summary

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The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain.

Detailed Description

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Chronic pain conditions are common and difficult to cure. As much as 30% of adults in Norway experience moderate-to-severe chronic pain, i.e., pain having lasted more than 3 months. Chronic pain is also the most common cause of sick leave and disability pension in Norway. Despite a clear request from the authorities, e-health interventions for chronic pain has not yet been tested and implemented.

The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain, using outcome measures such as pain intensity, pain acceptance, anxiety/depression and quality of life.

The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses. The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material. The 9 modules will be distributed over minimum 27 days (minimum 3 days per module). The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group. Both groups will receive outcome measures to complete at baseline and at 3, 6 and 12 months.

Post-RCT, the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only.

Conditions

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Chronic Pain, Widespread

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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EPIO (e-health intervention)

Participants will get access to one module every third day (total 9 modules). The app consists of cognitive behavioral pain self-management material, including educational material and relaxation training exercises.

Group Type EXPERIMENTAL

EPIO

Intervention Type BEHAVIORAL

App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.

treatment as usual

Participants will get treatment as usual during the study. All participants will get access to the app after ended study if interested.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental without introduction group and follow up phone calls

One extra arm (non randomized) has been included to examine whether participants who receive the EPIO intervention without receiving an introduction session and follow up phone calls will still describe benefiting from the receiving the intervention

Group Type ACTIVE_COMPARATOR

EPIO

Intervention Type BEHAVIORAL

App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.

Interventions

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EPIO

App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.

Intervention Type BEHAVIORAL

Other Intervention Names

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e-health intervention for chronic pain

Eligibility Criteria

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Inclusion Criteria

* Chronic pain (pain \> 3 months)
* \> 18 years of age
* Able to write/read/speak Norwegian
* Have their own smart phone, PC or tablet

Exclusion Criteria

* Cancer related pain
* Migraine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

University College of Southeast Norway

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role collaborator

Drammen municipality, Norway

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

University of Twente

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lise Solberg Nes

Center Director, Head of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lise Solberg Nes, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Bostrom K, Borosund E, Eide H, Varsi C, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Stavenes Stole H, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L. Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial. J Med Internet Res. 2023 Aug 25;25:e47284. doi: 10.2196/47284.

Reference Type DERIVED
PMID: 37624622 (View on PubMed)

Bostrom K, Varsi C, Eide H, Borosund E, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Nordang EF, Stubhaug A, Nes LS. Engaging with EPIO, a digital pain self-management program: a qualitative study. BMC Health Serv Res. 2022 Apr 29;22(1):577. doi: 10.1186/s12913-022-07963-x.

Reference Type DERIVED
PMID: 35488295 (View on PubMed)

Eiken AG, Nordanger DO, Solberg Nes L, Varsi C. Patients' Experiences of Using an eHealth Pain Management Intervention Combined With Psychomotor Physiotherapy: Qualitative Study. JMIR Form Res. 2022 Mar 16;6(3):e34458. doi: 10.2196/34458.

Reference Type DERIVED
PMID: 35293866 (View on PubMed)

Varsi C, Ledel Solem IK, Eide H, Borosund E, Kristjansdottir OB, Heldal K, Waxenberg LB, Weiss KE, Schreurs KMG, Morrison EJ, Stubhaug A, Solberg Nes L. Health care providers' experiences of pain management and attitudes towards digitally supported self-management interventions for chronic pain: a qualitative study. BMC Health Serv Res. 2021 Mar 25;21(1):275. doi: 10.1186/s12913-021-06278-7.

Reference Type DERIVED
PMID: 33766028 (View on PubMed)

Bostrom K, Borosund E, Varsi C, Eide H, Flakk Nordang E, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L. Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study. JMIR Form Res. 2020 Oct 23;4(10):e23893. doi: 10.2196/23893.

Reference Type DERIVED
PMID: 33094734 (View on PubMed)

Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Borosund E, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Haaland-Overby M, Bevan K, Zangi HA, Stubhaug A, Solberg Nes L. A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People With Chronic Pain: Design and Development of EPIO. J Med Internet Res. 2020 Jan 21;22(1):e15889. doi: 10.2196/15889.

Reference Type DERIVED
PMID: 31961331 (View on PubMed)

Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Mirkovic J, Borosund E, Haaland-Overby M, Heldal K, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Solberg Nes L. Patients' Needs and Requirements for eHealth Pain Management Interventions: Qualitative Study. J Med Internet Res. 2019 Apr 1;21(4):e13205. doi: 10.2196/13205.

Reference Type DERIVED
PMID: 30877780 (View on PubMed)

Related Links

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http://epio.no

Study web page

Other Identifiers

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2018/799

Identifier Type: -

Identifier Source: org_study_id

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