Chronic PainIPSinPainNCT02697656
The Effectiveness of Individual Placement and Support in Chronic Pain Patients
A study testing IPS, Self-help and Treatment as usual in people with Chronic Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but has never previously been tested for patients with chronic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- IPS, Self-help and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2015to Dec 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Living too far away from the pain clinic (outside of Oslo)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but has never previously been tested for patients with chronic pain. In fact, employment support is rarely provided in pain clinics, despite an increasing focus on integrating work and health in all patient treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- IPS, Self-help, Treatment as usual
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPSBehavioural
Individualized job support provided by an employment specialist
Self-helpBehavioural
Self-help resources on obtaining employment and coping with chronic pain
Treatment as usualBehavioural
Transdisciplinary treatment at the pain clinic. This includes medical, psychological and physiotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual + self-help | Active comparator | Interdisciplinary treatment as usual at the outpatient pain clinic + an additional self-help binder with resources about pain management and employment advice. Receives: Behavioral: Self-help; Behavioral: Treatment as usual |
| Treatment as usual + IPS | Experimental | Individual job support (IPS) as an integrated part of the interdisciplinary treatment at the outpatient pain clinic. Receives: Behavioral: IPS; Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Competitive employment
Hours/days/weeks worked in competitive employment the last 12 months
Measured: At 12-months follow-up
Secondary outcomes (3)
Health-related quality of life
EQ5D termometer
Measured: 6 and 12 months follow-up
Pain-related disability
Oswestry, modified to chronic pain patients
Measured: 6 and 12 months follow-up
Pain intensity
Numeric Rating Scale
Measured: 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Directorate of Health, Norwegian Labour and Welfare Administration
- Responsible party
- Principal investigator, Silje Endresen Reme, Oslo University Hospital
- Investigators
- Silje E Reme, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697656
- Sponsor's protocol ID
- 2015/14224
- Other IDs
- 2015
- Acronym
- IPSinPain
- Status last verified
- Jun 2021
- First submitted
- 18 Jan 2016
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23161326Bond 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.
PubMed 18407876Sveinsdottir 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.
PubMed 35234931Linnemorken 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.
PubMed 29433493
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02697656
- Acronym / sponsor ID
- IPSinPain / 2015/14224
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Directorate of Health, Norwegian Labour and Welfare Administration
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individual Placement and support (IPS) is an evidence-based approach originally developed to help people with severe mental disorders to obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but has never previously been tested for patients with chronic pain. In fact, employment support is rarely provided in pain clinics, despite an increasing focus on integrating work and health in all patient treatment (OECD, 2013). The aim of this study is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual + self-help | Active comparator | Behavioral: Self-help, Behavioral: Treatment as usualInterdisciplinary treatment as usual at the outpatient pain clinic + an additional self-help binder with resources about pain management and employment advice. |
| Treatment as usual + IPS | Experimental | Behavioral: IPS, Behavioral: Treatment as usualIndividual job support (IPS) as an integrated part of the interdisciplinary treatment at the outpatient pain clinic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Living too far away from the pain clinic (outside of Oslo)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPSIndividualized job support provided by an employment specialist | Behavioural | Treatment as usual + IPS |
| Self-helpSelf-help resources on obtaining employment and coping with chronic pain | Behavioural | Treatment as usual + self-help |
| Treatment as usualTransdisciplinary treatment at the pain clinic. This includes medical, psychological and physiotherapy treatment. | Behavioural | Treatment as usual + IPS, Treatment as usual + self-help |
Primary outcome
Competitive employment
Time frame: At 12-months follow-up
Hours/days/weeks worked in competitive employment the last 12 months
3 secondary outcomes
Health-related quality of life
Time frame: 6 and 12 months follow-up
Pain-related disability
Time frame: 6 and 12 months follow-up
Pain intensity
Time frame: 6 and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Background: PubMed 23161326Bond 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.
- Background: PubMed 18407876Bond 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.
- Derived from this study: PubMed 35234931Sveinsdottir 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.
- Derived from this study: PubMed 29433493Linnemorken 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.
- The Study ProtocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silje E Reme, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPS, Self-help and Treatment as usual in people with Chronic Pain, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 1 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 11 Jun 2021. 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 Norway. 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?
Competitive employment (time frame: At 12-months follow-up). 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 NCT02697656, which also lists 4 linked publications.
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 11 Jun 2021.