- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02697656
The Effectiveness of Individual Placement and Support in Chronic Pain Patients (IPSinPain)
A Randomized Controlled Trial Assessing the Effectiveness of the Individual Placement and Support Model for Patients With Chronic Pain in an Outpatient Hospital Pain Clinic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. IPS represents a relatively new approach to vocational rehabilitation and incorporates following principles: (1) Every person that wants to work, can work given that the person is provided with the appropriate work and environment. (2)The goal is employment in regular, competitive employment. (3) IPS is integrated with treatment. (4) Job search is individualised; based on the participants' preferences and competence. (5) Work incentives planning is provided; which includes counselling about how work can influence social security and other public benefits. The intention of this benefits counselling is to enable the participant to make informed decisions about work (job starts and changes). (6) The job support is not time-limited. (7) Finally, IPS differs from more traditional employment services in that it does not involve pre-vocational training, often referred to as "train, then place". (8) In IPS job search starts as soon as the client expresses an interest in work. Therefore, IPS follows the principle "place, then train".
The effectiveness of IPS for patients with severe mental illness is well documented. International research shows that IPS is more effective than other types of employment programs for this group of clients. However, the effect of IPS on patients with chronic pain in an outpatient hospital clinic is largely unknown.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway
- Silje Endresen Reme
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients referred to the pain clinic and eligible for interdisciplinary treatment
- Not currently working (long-term sick leave, disability pension or unemployed)
- Expressed desire to work
Exclusion Criteria:
- Living too far away from the pain clinic (outside of Oslo)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment as usual + self-help
Interdisciplinary treatment as usual at the outpatient pain clinic + an additional self-help binder with resources about pain management and employment advice.
|
Self-help resources on obtaining employment and coping with chronic pain
Transdisciplinary treatment at the pain clinic.
This includes medical, psychological and physiotherapy treatment.
|
|
Experimental: Treatment as usual + IPS
Individual job support (IPS) as an integrated part of the interdisciplinary treatment at the outpatient pain clinic.
|
Transdisciplinary treatment at the pain clinic.
This includes medical, psychological and physiotherapy treatment.
Individualized job support provided by an employment specialist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Competitive employment
Time Frame: At 12-months follow-up
|
Hours/days/weeks worked in competitive employment the last 12 months
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At 12-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life
Time Frame: 6 and 12 months follow-up
|
EQ5D termometer
|
6 and 12 months follow-up
|
|
Pain-related disability
Time Frame: 6 and 12 months follow-up
|
Oswestry, modified to chronic pain patients
|
6 and 12 months follow-up
|
|
Pain intensity
Time Frame: 6 and 12 months follow-up
|
Numeric Rating Scale
|
6 and 12 months follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Silje E Reme, PhD, Oslo University Hospital
Publications and helpful links
General Publications
- Bond GR, Drake RE. Making the case for IPS supported employment. Adm Policy Ment Health. 2014 Jan;41(1):69-73. doi: 10.1007/s10488-012-0444-6.
- Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008 Spring;31(4):280-90. doi: 10.2975/31.4.2008.280.290.
- Sveinsdottir V, Jacobsen HB, Ljosaa TM, Linnemorken LTB, Knutzen T, Ghiasvand R, Reme SE. The Individual Placement and Support (IPS) in Pain Trial: A Randomized Controlled Trial of IPS for Patients with Chronic Pain Conditions. Pain Med. 2022 Sep 30;23(10):1757-1766. doi: 10.1093/pm/pnac032.
- Linnemorken LTB, Sveinsdottir V, Knutzen T, Rodevand L, Hernaes KH, Reme SE. Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain. BMC Musculoskelet Disord. 2018 Feb 13;19(1):47. doi: 10.1186/s12891-018-1962-5.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/14224
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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