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
Phase: NA
Conditions: Chronic Pain
Sponsor: Oslo University Hospital

STUDY PROTOCOL
Open Access
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
Lene Therese B. Linnemørken1, Vigdis Sveinsdottir2, Thomas Knutzen1, Linn Rødevand1,5,
Kjersti Helene Hernæs3 and Silje Endresen Reme1,4*
Abstract
Background: Work disability involves large costs to the society as well as to the individual. Work disability is
common among people with chronic pain conditions, yet few effective interventions exist. Individual Placement
and Support (IPS) is an evidence-based work rehabilitation model originally developed to help people with severe
mental illness obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is
well documented, but the model has never before been tested for patients with chronic pain.
Methods/design: The aim of the IPS in Pain trial 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. The study is a
randomized controlled trial comparing pain treatment with integrated IPS to treatment as usual in unemployed
patients suffering from various chronic pain conditions. The primary outcome of the study is labor market
participation during 12 months after enrollment, and secondary outcomes include physical and mental health and
well-being, collected at baseline, 6, and 12 months. Finally, there will be an additional long-term follow-up for the
primary outcome, which will be collected through a brief phone interview at 24 months.
Discussion: The IPS in Pain trial will be the first report of the effectiveness of the IPS model of supported
employment applied in an outpatient setting for chronic pain patients. It will thus provide important information
about the effectiveness of repurposing IPS to a new patient group in great need of job support.
Trial registration: Clinicaltrials.gov: NCT02697656. Registered January 15th, 2016.
Keywords: Chronic pain, Coping, Individual placement and support, Supported employment, Integrated care,
Randomized controlled trial, Vocational rehabilitation, Unemployment, Work disability
* Correspondence: silje.reme@psykologi.uio.no
1Department of Pain Management and Research, Oslo University Hospital,
Oslo, Norway
4Department of Psychology, Faculty of Social Sciences, University of Oslo,
Oslo, Norway
Full list of author information is available at the end of the article
© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Linnemørken et al. BMC Musculoskeletal Disorders  (2018) 19:47 
https://doi.org/10.1186/s12891-018-1962-5

Background
Chronic pain is a major health problem in Norway and
elsewhere, with nearly 30% affected in the Norwegian
population [1, 2]. Chronic pain often causes significant
difficulties in personal and social life, and commonly has
negative impact on work ability and participation in the
labor market [3]. Absence from the labor market is asso-
ciated with significant negative individual consequences,
such as reduced quality of life and a decline in health
[4–7]. Chronic pain also constitutes a substantial socio-
economic burden. In Norway, long-term back pain alone
costs more than 4 million euros in sick leave and more
than 6 million euros in social welfare annually [8].
As chronic pain affects many facets of life, it is inter-
nationally agreed that complex pain conditions require a
multidisciplinary approach [9]. Indeed, evidence suggests
that integrated treatment approaches provide better
results compared to sequential processes [10]. In inte-
grated approaches, health care professionals from differ-
ent educational backgrounds assume complementary
roles, and their unique expertise is required when the
team assesses and treats the patient. The composition of
multidisciplinary treatment teams varies, but generally
includes three common elements: (1) medical manage-
ment to reduce symptoms, (2) physical therapy and
training to strengthen muscles and improve balance,
body awareness and respiration pattern, and (3) cogni-
tive and emotional treatment to enhance coping [9]. We
would argue for adding a fourth element: (4) vocational
support to manage work. Despite the recent focus on in-
tegrating work and health in all patient treatment [11],
work-related support is rarely provided in pain clinics
(Fig. 1).
Within the field of vocational rehabilitation, it is com-
mon to distinguish between two main models; train and
place and place and train. The former is the traditional
approach, where training of clients takes place in shel-
tered workshop jobs, or work experiences in ordinary
businesses, with the goal of acquiring necessary skills
before
placement
in
competitive
employment.
In
Norway, vocational services as usual mostly involve train
and place approaches, including sheltered training or
subsidized work. This is also what pain patients on long-
term disability pension are offered from the public wel-
fare services in addition to their medical treatment, with
little or no integration between the interventions [12].
The place and train approach does not involve prevo-
cational training, but focuses on direct employment in
the competitive labor market instead. Individual Place-
ment and Support (IPS) is an evidence-based practice
within this approach. The aim of IPS is to provide indi-
vidual job support to help people with disabilities
achieve competitive employment in the ordinary labor
market [13]. The model was originally developed for
people with severe mental disorders [14, 15], and job
support was integrated with mental health treatment
rather than being provided as a separate component. A
core principle in IPS is that patients are not screened for
work readiness, anyone who expresses a desire to work
should be supported in order to find a suitable job and
environment for that particular individual [16]. More-
over, IPS emphasizes individual preferences and compe-
tence. IPS focuses directly on the ordinary labor market,
with rapid job search and contact with employers, along
with individualized support throughout the process.
Previous studies have consistently shown that IPS pro-
duces better work outcomes compared to other types of
employment programs for patients with severe mental
disorders [17]. In those patients, competitive employ-
ment has also been associated with improvements in
Fig. 1 Flowchart
Linnemørken et al. BMC Musculoskeletal Disorders  (2018) 19:47 
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some non-vocational outcomes, including reductions in
outpatient psychiatric treatment and better self-esteem
[18]. Despite substantial evidence of the effectiveness of
IPS for patients with mental illnesses, the effect of IPS
has never been investigated for patients with chronic
pain. Pain is an experience that involves affective, motiv-
ational, and sensory components [19, 20], and given the
similarities and overlap between mental illness and
chronic pain [21–24], an investigation of repurposing
IPS to chronic pain appears promising. Indeed, in a pre-
vious pilot study conducted to inform this trial, partici-
pants reported mostly positive experiences with IPS as
an integrated part of their interdisciplinary pain rehabili-
tation [25].
Methods/design
Aims and objectives
The main aim of this study is to investigate the effective-
ness of IPS as an integrated part of the interdisciplinary
treatment for patients with chronic pain in a hospital
outpatient clinic. The IPS in Pain trial is designed to
answer the following questions:
1) Will IPS result in a higher rate of competitive
employment compared to treatment as usual
(TAU)?
2) Will IPS result in more total hours of competitive
work and higher wages than TAU?
3) Will IPS be more effective than TAU in terms of
improving health status and quality of life?
4) Is IPS cost-effective compared to TAU?
Outcome measures
The primary outcome is the rate of competitive employ-
ment during 12 months follow-up after inclusion in the
study. Competitive employment rate is here defined as
ordinary paid employment in the competitive labor mar-
ket, using a threshold of at least one day of work, corre-
sponding to the Swedish IPS trial by Bejerholm et al.
[26]. Success in employment will also be measured using
a range of standardized indicators of employment out-
comes commonly used in previous IPS studies [27]. This
includes employment duration (e.g. cumulative numbers
of weeks worked in all jobs), job intensity (e.g. percent-
age working at least 20 h a week), and productivity (e.g.
total hours worked/wages).
The secondary outcomes concern health status and
quality of life, and involve the following questionnaires:
Health-related quality of life will be measured using
the Euro-Quol Visual Analogue Scale (EQ-VAS), a verti-
cal scale ranging from 0 (“worst imaginable health state”)
to 100 (“best imaginable health state”) [28].
Pain-related disability will be measured using a modi-
fied version of the Oswestry Disability Index (ODI) [29],
which consists of 10 items concerning the effect of back
pain on different activities of daily life. The modified
ODI is identical to ODI with one exception; the word
“back” (which occurs once, in the introduction to the
form) is deleted. Each item is scored from 0 to 5, with
higher values representing more disability.
Psychological distress will be measured using the
Hopkins Symptom Checklist-25 (HSCL-25) [30]. The
questionnaire consists of 25 questions concerning anx-
iety, depression and somatization. A mean total score of
< 1.75 is within the normal range, while a score of 1.75
and above indicates psychological distress in need of
treatment.
Pain intensity and bothersomeness will be measured
using the Numeric Rating Scale (NRS) with scores from
0 to 10. Pain intensity will be measured by asking
patients to report how intense their pain usually is, from
0 (no pain) to 10 (worst possible pain), and pain bother-
someness will be measured by asking how bothersome
the pain usually is, from 0 (not bothersome at all) to 10
(worst possible bother).
Data collection and management
All data will be collected through self-reported surveys.
Baseline and follow-up assessments will be collected
through a local electronic pain registry already estab-
lished and in use at the clinic. Each patient assessed at
the pain clinic meets one hour prior to their first sched-
uled consultation to receive a pre-programmed Lenovo
tablet with secure software. The tablet has an app (i.e.
Infopad) installed for collecting the answers to the study
questionnaires. The registry has been approved by the
Data Protection Officer at Oslo University Hospital, and
requires a dedicated informed consent. The research
coordinator or other members of the staff will be avail-
able to answer any questions the participants may have
during the completion. Paper options will be available.
Baseline assessment
All patients complete a standardized screening on the
same day as their first consultation at the clinic. In-
cluded in the screening are questionnaires about demo-
graphical and clinical characteristics, such as physical
and mental health and employment status. If the screen-
ing was conducted more than two months earlier, the
patient will be asked to complete the screening again to
ensure reliable baseline data. No procedures related to
the trial will take place before the baseline assessment
has been completed.
Follow-up assessments
The follow-up assessments will be conducted 6 and
12 months after randomization. The research coordin-
ator will perform the follow-up assessments, and the
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location will either be at the clinic or the participant’s
home, depending on their preferences. For the primary
outcome (rate of competitive employment) we will also
add a long-term follow-up collected through a brief
phone interview at 24 months (Fig. 1).
Data management
Electronic data collected using tablets will automatically
be transferred to and stored in a secure online database.
Data collected on paper will be entered manually by the
research coordinator, after which the original question-
naires will be destroyed. The information will be de-
identified, and the identifier will be secured in a locked
and fireproof safe.
Study design
The study is designed as a randomized controlled trial
(RCT) in order to respond to the main aim of the study,
which is to conduct an effect evaluation of IPS for
patients with chronic pain (Fig. 1). The effect evaluation
is further accompanied by a cost-benefit analysis to pro-
vide an economic assessment of potential effects of the
intervention.
Participants
Number and source of participants
The goal is to recruit 80 participants to the trial (see
sample size calculations). Patients will be consecutively
recruited and randomized at the Department of Pain
Management and Research at Oslo University Hospital,
Norway. All patients referred to the clinic eligible for
participation will be informed about the study and in-
vited to participate.
Recruitment
All clinicians, including the office staff, have been
trained in the inclusion procedures and are able to in-
form and include patients during their consultations.
Clinicians can also inform the primary investigator and/
or the coordinator of the study about potential partici-
pants, who will then contact the patient by phone.
Posters and brochures providing information about the
study and contact information to the researchers are dis-
tributed throughout the clinic, allowing patients to make
direct contact if interested.
Patients who want to participate will be informed of
their rights according to the Helsinki declaration, receive
additional information about the study, and sign a writ-
ten informed consent before any trial related procedure
takes place. The design of the trial will be explained to
the patients in detail. For those included, baseline assess-
ment and randomization will be performed.
Inclusion criteria
1) Patients referred to the pain clinic and eligible for
interdisciplinary treatment
2) Not employed (long-term sick leave, disability
pension, or unemployed)
3) Expressed desire to work
4) Age between 18 and 65
5) Living within a reasonable distance to the clinic (i.e.
in the city of Oslo)
Exclusion criteria
1) Insufficient language skills to answer questionnaires
in Norwegian
Randomization
Participants will be randomly allocated to one of the fol-
lowing conditions: 1) IPS and treatment as usual (the
intervention group), or 2) treatment as usual (the con-
trol
group).
The
randomization
will
be
conducted
through a randomization app called RandomizeIt with a
1:1 randomization ratio. A 2:1 randomization ratio will
be applied the first months of recruitment to ensure that
the employment specialists obtain sufficient clients in
their portfolio. Towards the end of the inclusion period,
a 1:2 randomization ratio will be applied to ensure simi-
lar group sizes. The principal investigator or the coord-
inator of the study will inform the participants about the
randomization outcome.
Interventions
Participants randomized to the intervention group will
receive job support according to the IPS model from an
employment specialist, in addition to treatment as usual.
The employment specialists will be included in the inter-
disciplinary treatment teams at the clinic. In addition to
ad hoc meetings on a regular basis, the employment spe-
cialists
and
the
pain
management
team
will
have
monthly meetings where they discuss all participants.
The employment specialists will deliver IPS employment
support according to a detailed manual [31], and adher-
ing to the eight principles of IPS: (1) eligibility based on
the patient’s own choice, (2) focus on competitive em-
ployment (i.e., jobs in integrated work settings in the
competitive job market at prevailing wages, with super-
vision provided by personnel employed by the business),
(3)
integration
of
mental
health
and
employment
services,1 (4) attention to patients’ preferences, (5) work
incentives planning, (6) rapid job search, (7) systematic
job development, and (8) individualized job support [32].
This implies that the job search and support is adapted
to the individual’s needs and challenges.
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Participants randomized to the control group will receive
treatment as usual, which involves interdisciplinary pain
management
provided
by
physicians
(anesthesiologist,
gynecologist, neurologist or specialist in physical medicine
and rehabilitation), psychologists, physiotherapists and
nurses. Usually, at least two professions follow the patients
over a time-period of one to twelve months, with a fre-
quency of every other week to once a month. In addition,
participants in the control group will receive a resource
manual with information about services and resources for
work disabled and unemployed, as well as self-help advice
and information about pain management. Finally, those
participants who are eligible for vocational rehabilitation
provided by the Norwegian Labor and Welfare Administra-
tion (NAV)2 are advised to contact their local NAV office
to receive employment services there.
Adaptations of the IPS model to the study context
IPS has traditionally been used for people with severe
mental illness. However, the model has also been used
for other populations, for example, people with post-
traumatic stress disorder, spinal cord injury, traumatic
brain injury, and autism spectrum disorder. In the
Supported Employment Fidelity Review Manual [33] the
authors specifically states that IPS units that serve other
populations will connect with another set of service pro-
viders than mental health practitioners. Employment
services in the current study are thus integrated with
interdisciplinary pain treatment and not mental health
treatment per se, although the interdisciplinary pain
treatment can involve a psychologist.
Furthermore, the organizational model in the current
study will include a NAV-coordinator located at the
clinic with access to the data systems of all the local
NAV offices surrounding the clinic. This position will
serve as a supplement to the services provided by the
employment specialists, and the position will mainly
serve the function of a case manager. Case management
in the United States emerged after the deinstitutionalization
of patients from the major psychiatric hospitals. A case
manager has a coordinating function and is responsible for
assessing needs and implementing plans. Although a case
manager initially had little direct contact with patients, the
modern clinical case manager’s role includes both clinical
and social work. In Norway, we do not have an equivalent
to a clinical case manager position. Here, the clinical func-
tion is placed within the mental health services, and the
social function at the local NAV offices. In the current
study, we want the NAV-coordinator to serve both these
functions. The coordinator will be the point of contact
between NAV and both participants and treatment pro-
viders, and one of the primary tasks for the coordinator will
thus be to give general advice on benefits and work incen-
tives. Since patients referred to the clinic belong to a wide
range of different NAV offices, we chose to make this adap-
tation in order to realistically be able to provide benefits
counselling and work incentives planning. Another import-
ant task for the coordinator is to provide support to the
participants when undergoing important changes in their
lives regarding work. The coordinator has training in
Motivational Interviewing (MI) and conducts regular meet-
ings with the participants. Most of the meetings take place
outside the clinic, often using assertive engagement and
outreach in the participants’ community. This part of the
coordinator role pertains to the clinical function of the case
manager.
Drop out and non-compliance
Participants who no longer wish to participate in the
study can inform the research group of their decision by
notifying their employment specialist, treatment pro-
vider, or the coordinator of the study. The research
coordinator will in any case contact participants who
drop out by phone, and ask if they want to report the
reason for withdrawal. If reasons are provided, these will
be registered on a dedicated drop out form. Whether
they only want to withdraw from further employment
support, or if they also want to withdraw from future
follow-ups, will also be registered. Finally, it will be reg-
istered if the participant gives permission for use of data
that has already been collected, or if they want these to
be deleted. Participants who drop out of the study will
still be included in the intention-to-treat (ITT) analyses.
Analyses
Sample size calculations
The sample size calculations are based on input-data
from international IPS studies, which have shown a
return to competitive employment rate of 23% for the
control group and 61% for the IPS group [34]. Consider-
ing these rates to be plausible, each group will require
31 participants to reach a statistically significant differ-
ence (using a 5% significance level and a strength of
90%). However, as IPS has never been investigated in
this patient group before, the effects found in this study
may be more moderate than those found in earlier stud-
ies conducted with people with severe mental illnesses.
A second possible scenario may be a return to competitive
work rate of 23% for the control group and 55% for the
IPS group, which would require 44 participants in each
group. Given that both these scenarios are plausible, we
aim to recruit at least 40 participants in each group.
Statistical analyses
The
analyses
will
follow
the
“intention
to
treat”
principle. The randomization will ensure that there are
no systematic differences between the IPS and control
group at baseline, both when it comes to observable as
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well as unobservable characteristics. We will compare
proportions employed in each group, and investigate
whether differences are statistically significant. Addition-
ally, we will perform regression analyses using logistic
regression models to investigate predictors of treatment
outcome. Groups will also be compared on secondary
outcome measures using survey data at baseline and 6
and 12 month follow-up.
Health economic analyses
Because IPS is provided in addition to TAU, the inter-
vention is more costly than TAU alone. A health eco-
nomic analysis will be conducted to investigate the
differences in costs relative to differences in effect (e.g.
competitive employment rates, hours of work, wage
rates, etc.) between the groups. This is commonly
referred to as the incremental cost-effectiveness ratio
(ICER). The analyses will also include data on health-
related quality of life as measured with the EQ-5D,
allowing for an estimation of costs per quality-adjusted
life-year (QALY).
IPS compliance
The IPS fidelity scale is an established measurement to
assess adherence to the IPS methodology [35], and fidel-
ity evaluations will be conducted in the initial phase of
the project (baseline) and every 6 months until recruit-
ment is completed. The evaluations will be conducted
by an independent and experienced evaluator adhering
to the well-established Norwegian translation of the IPS
fidelity scale [36], and will provide information on com-
petence and methodology in conducting the interven-
tion, as well as the frequency of contact and interaction
with the participants. In the Supported Employment Fi-
delity Review Manual [37] it is recommended that at
least two reviewers conduct fidelity reviews to increase
reliability of the findings. The recommendations for the
interviewing format is conversational rather than a
structured interview. There are recommendations for
sample questions for each fidelity item, organized by
stakeholder groups, although not a complete set of ques-
tions to answer each item or subcriteria item. After the
review the reviewers independently rate the project on
the IPS Fidelity Scale and then conducts consensus scor-
ing to compare ratings, resolve disagreements, and
decide upon final ratings. There are, however, several
challenges when conducting fidelity reviews this way.
One is that reviewer competency can be low, especially
in countries where IPS is relatively new, as in Norway,
or where the raters are not calibrated with the origina-
tors of the model. Another challenge is the unstructured
interview form, which makes it difficult to obtain high
inter-rater reliability. In addition, the risk of low consistency
between both reviews and reviewers due to the individual
approach to interview questions and interpretations of an-
swers and observations will always be present.
In the fidelity reviews for the current study we have
thus chosen a slightly different approach that involves:
1) a reviewer with operational experience on all levels of
IPS, training in doing fidelity reviews from the origina-
tors of the model, and calibration with The IPS Employ-
ment Center at The Rockville Institute, 2) a fidelity
review tool with a matrix of 260 questions specifically
developed to answer main items and subcriteria items in
the IPS fidelity scale. The 260 questions will be distrib-
uted to seven different interview objects, three observa-
tional objects and two document objects. All questions
are structured with answer options, eliminating the need
for interpretation of each question; and 3) a digital scor-
ing tool to avoid errors in scoring data transfer. We
believe this will ensure higher reliability as well as
consistency across fidelity reviews, with 50% less re-
sources needed.
Any significant deviations from the IPS principles
revealed by the fidelity reviews will be noted and com-
municated back to the employment specialists to ensure
and increase quality.
Confidentiality
Personal confidentiality is guaranteed for all participants.
All data collected in the study is regarded as confiden-
tial, and the memory sticks and all data containing per-
sonal information will be securely stored in a fireproof
safe.
Conclusion
To our knowledge, the IPS in Pain trial will be the first
RCT to investigate the effectiveness of IPS for patients
with chronic pain. The study will provide important
evidence-based information about the effectiveness of
repurposing the IPS model to this new patient group. It
will further provide evidence-based knowledge about the
value of integrating work rehabilitation in a somatic hos-
pital setting, and the feasibility and effectiveness of pro-
viding the job support in a parallel, as opposed to
sequential, way.
Endnotes
1See “Adaptations of the IPS model to the study
context”
2NAV administers schemes such as unemployment
benefit, work assessment allowance, sickness benefit,
pensions, child benefit and cash-for-care benefit.
Abbreviations
EQ-5D: European Quality of Life – 5 Dimensions; HSCL-25: Hopkins Symptom
Checklist - 25; IPS: Individual Placement and Support; ITT: Intention-To-Treat;
NAV: Norwegian Labor and Welfare Administration; NRS: Numeric Rating
Scale; RCT: Randomized Controlled Trial
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Funding
The project is funded by the Norwegian Ministry of Health and Ministry of
Labor. The funding sources do not have any role in the design of the study,
data collection, analysis and interpretation of data, or decisions to submit
articles for publication.
Availability of data and materials
The data collected and analysed in the study will be available from the
corresponding author on reasonable request. However, restrictions apply to
the availability of these data due to patient privacy concerns, and the data
will therefore not be publicly available.
Trial steering committee (TSC)/ scientific advisory board
The trial steering committee is responsible for the independent oversight of
the progress of the trial and investigation of any adverse events. The TSC is
composed of:

Professor Silje Endresen Reme (principal investigator)

Professor Audun Stubhaug

Dr. Lars-Petter Granan

Dr. Tone Marte Ljosaa

Dr. Henrik Børsting Jacobsen
Authors’ contributions
SER conceived the study design and developed the initial protocol for the
trial. SER is the principal investigator of the trial, while LTBL and LR are trial
coordinators. LTBL and SER drafted the manuscript, while TK, VS and KHH
drafted parts of the manuscript and revised the manuscript for critical
intellectual content. All authors read and approved the final manuscript.
Ethical approval and consent to participate
The project was submitted to the Norwegian Regional Ethical Committee
and therefrom referred to the Data Protection Officer at Oslo University
Hospital, who approved the study (project number: 2015/14224). All the
principles of the Helsinki declaration will be followed. After a complete
description of the study’s process and purposes has been given, each
participant will sign a declaration of voluntary participation. The right to
withdraw from the study at any time without any explanation, and without
any consequences for the further treatment at the clinic, will be emphasized.
Consent for publication
Not applicable.
Competing interests
TK is the sole proprietor of IPS Norway, a company that provides IPS services
and consulting services. The remaining authors declare that they have no
competing interests.
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Author details
1Department of Pain Management and Research, Oslo University Hospital,
Oslo, Norway. 2Uni Research Health, Uni Research, Bergen, Norway. 3Oslo
University Hospital, Oslo, Norway. 4Department of Psychology, Faculty of
Social Sciences, University of Oslo, Oslo, Norway. 5NORMENT, KG Jebsen
Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo
University Hospital, Oslo, Norway.
Received: 1 December 2017 Accepted: 6 February 2018
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