The primary objective of this current project is to study the (cost-) effectiveness of Motivational interviewing in non-specific musculoskeletal chronic pain patients who are indicated for pain rehabilitation treatment. It is hypothesized that an MI…
ID
Source
Brief title
Condition
- Other condition
- Musculoskeletal and connective tissue disorders NEC
Synonym
Health condition
Chronische aspecifieke musculoskeletale pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1st research question (effect evaluation)
The primary outcome of the effect-evaluation will be the mean level of
participation of the participants at baseline (T0), T2, T3, and T4.
Participation will be measured by the Utrecht Scale for Evaluation of
Rehabilitation-Participation (USER-P) (van der Zee, Post et al. 2008; van der
Zee, Priesterbach et al. 2010). The USER-P covers three aspects of
participation by three separate scales namely Frequency, Restriction, and
Satisfaction. It consists of 32 items and it was tested for reproducibility
(van der Zee, Priesterbach et al. 2010). Each of the three sum scores is
converted to a scale ranging from 0-100 scale, where higher scores reflect more
social participation (each higher frequency, less restrictions, higher
satisfaction). The psychometric qualities are studied at this moment (Van der
Zee, Kap et al. 2011; Van der Zee and Post 2011).
Primary process measure of the first research question is treatment drop-out.
Drop-out will be registered in the patient registry in the institution by as
whether the patient was finally indicated for rehabilitation (or was
dropped-out by the professionals), and has finished the pain rehabilitation as
proposed or dropped out prematurely.
2nd research question (mediation)
Adherence to the pre-treatment intervention and to the rehabilitation treatment
(which is also assessed for research question 1) could mediate the relationship
between treatment and outcome.
3rd research question (cost-effectiveness and cost-utility)
To evaluate the economic effects of MIP and ACC, relevant cost categories of
resource use and volumes of these categories must be measured. Finally, volumes
have to be multiplied by the belonging costs.
Costs can be divided in direct and indirect costs and sub classified in health
care costs and non-health care costs(Hakkaart- van Roijen, Tan et al.
Geactualiseerde versie 2010). Four cost categories are resulting from this.
Direct costs inside the health sector are costs which result directly from a
certain intervention or treatment. They include in this study costs of the pain
rehabilitation treatment and the economic consequences of the intervention
condition in terms of changes in health care utilisation. Indirect costs inside
the health sector are medical costs in gained life years due to a special care
or treatment and do not apply here. Direct costs outside the health sector
include costs of (un)paid help, out-of pocket expenses, and travel costs of
attending the pain rehabilitation treatment. Indirect costs outside the health
sector include production losses (absenteeism) due to the chronic pain
problem(Hakkaart- van Roijen, Tan et al. Geactualiseerde versie 2010)
Indirect (non-)health care costs such as medical consumption is assessed by a
cost diary in which the participants record medical consumption related to
their chronic pain(Goossens, Rutten-van Molken et al. 2000) and costs of
informal care and domestic help. Therefore, the Trimbos/iMTA questionnaire for
Costs associated with Psychiatric Illness (Tic-p) (Hakkaart-van Roijen, van
Straten et al. 2002) is used. This self-reporting questionnaire consists of 15
items and assesses health care use a recall period of 3 months.
Productivity losses are assessed by the Short Form Health and Labor
Questionnaire (SF-HLQ)(Hakkaart-van Roijen and Bouwmans 2007). The SF-HLQ
measures the extent of production losses of paid and unpaid work in four
modules: absence from work, reduced productivity at paid work, unpaid labor
production and impediments to paid and unpaid labor. It consists of 11 items
and is added to the TIC-P.
Costs will be calculated by multiplying quantity (volume) by cost price and
calculating the sum total of the various types of costs(Drummond and McGuire
2001). To analyse differences in costs, costs per patient-year were calculated.
This means that the observed costs of the participants will be extrapolated to
a 1-year period. The updated Dutch manual for cost analysis in health care
research will be used containing guidelines for standardized cost
prices(Hakkaart- van Roijen, Tan et al. Geactualiseerde versie 2010). Where no
standard cost prices are available, real costs or tariffs will be used to
estimate costs. Cost prices will be presented in Euros and the baseline year is
2012, or otherwise discounted. The discounting rate of costs is 4%, these of
effects 1.5%(Oostenbrink, Koopmanschap et al. 2002; O'Brien, Staud et al. 2010;
Hakkaart- van Roijen, Tan et al. Geactualiseerde versie 2010).
To weight costs against effects of the MIP-/ ACC intervention, participation as
well as quality of life is used as effect measure. Participation is the primary
outcome measure and described above, quality of life is measured by the
Short-Form 36 (SF-36) General Health Survey. This is a general self-report
measure of health status and includes eight health concepts which can be used
to measure physical and mental functioning(Ware and Kosinski 2001). This
questionnaire has been extensively tested for validity in various countries,
disease groups, and settings(Aaronson, Muller et al. 1998).
For the cost-utility analysis (CUA), costs per year are weighted by utility.
Therefore, costs as mentioned above are used. To measure utility, the quality
of life measure is also used.
4th research question (process evaluation)
Feasibility of the planned intervention in terms of pre-treatment integrity and
fidelity (dose of treatment) is assessed by questionnaires which the
participating nurses have to fill after every pre-treatment session. The
certain steps taken during the intervention, the content of the discussion
during the sessions, and the clients* active participation have to be
documented in this semi-structured questionnaire. The structure will be based
on the work of Steckler and Linnan (Steckler and Linnan 2002) and adapted to
the specific situation of our study.
Also given the explicit emphasis in MI as a spirit rather than a
technique(Rollnick, Butler et al. 2010), the check of treatment integrity and
treatment fidelity is necessary. Therefore, the MI Treatment Integrity Code
(MITI version 3.1)(Moyers, Martin et al. 2010) will be used. It has shown to be
a cost-effective and reliable tool (!!! INVALID CITATION !!!) which is also a
validated instrument to check MI-fidelity(Forsberg, Berman et al. 2008; Moyers,
Martin et al. 2010) . Although the MITI is developed with the intention to be
used in non-research settings(Moyers, Martin et al. 2010), Moyers et al. (2005)
state that it also can be used in trials examining MI. Feedback during the
training and during intervision sessions will be also given based on the MITI.
Research has also shown that proficiency rating by skilled coders predicted
treatment outcome (Miller and Mount 2001; Moyers, Martin et al. 2003; Madson
and Campbell 2006). To be able to do so, all pre-treatment sessions are audio
taped, and a random sample will be scored by the above mentioned MITI
instrument.
5th research question (process evaluation)
Satisfaction in participants, and satisfaction and experiences with the
intervention in nurses and rehabilitation consultants will be explored. Also
the perceived client-centeredness is assessed.
In participants, the satisfaction with the pre-pain rehabilitation treatment
and the pain rehabilitation treatment will be assessed separately by means of a
structured questionnaire. At the end of the pre-treatment (either MIP or ACC)
and at the end of the rehabilitation treatment it will be assessed. Both
questionnaires are rated on a 4-point Likert scale ranging from totally
disagree (0) up to totally agree (4).
In the case of drop-out from the treatment, the participant is still asked for
ratings on satisfaction with the (pre-)treatment and about reasons for drop-out
from treatment. The information will be used to evaluate satisfaction with pain
rehabilitation and of reasons for drop-out from treatment for the process
evaluation. It has to be said that we are interested in reasons for dropping
out from the treatment not about reasons for dropping out from the study. In
the latter case, we do not ask the participant to give any reason for this.
The stage of change is assessed by the Multidimensional Pain Readiness to
Change Questionnaire 2 (short version). It measures the chronic pain
participants* readiness to change. The questionnaire is based upon the
transtheoretical model of behavior change of Prochaska and DiClemente. The
MPRCQ2-26 consists of 26 items and is scores on a 7-point Likert scale
(Nielson, Jensen et al. 2003; Nielson, Jensen et al. 2008; Nielson, Armstrong
et al. 2009). Psychometric properties are evaluated and appeared to be
satisfactory (Nielson, Armstrong et al. 2009).
Client-centredness is evaluated by the Client Centred Care Questionnaire
(CCCQ). The questionnaire was originally developed for the use in clients
receiving homecare(de Witte, Schoot et al. 2006). By making some minor
revisions, it can also be used in the rehabilitation setting(Schoot, Friesen et
al. 2010). It has shown good psychometric qualities(de Witte, Schoot et al.
2006).
In the participating nurses, experiences will be explored during the
supervision meetings. The nurses are also asked to fill in a semi-structured
questionnaire about their satisfaction and experiences with the intervention
and related barriers and improvements at the end of the intervention.
Secondary outcome
Secondary outcomes of the first research question are motivation, adherence to
the (pre)treatment, level of functioning, pain intensity, quality of life
(SF-36), credibility of the treatment, self-efficacy, and self-reported main
complaints.
Motivation is assessed by the Treatment Motivation Questionnaire (TMQ). The TMQ
assesses intrinsic and extrinsic information about entering and remaining
treatment(Ryan, Plant et al. 1995). It consists of 26 items representing the
factors internal and external motivation, interpersonal help seeking and
confidence in treatment. Items are slightly adapted to the rehabilitation
context.
Adherence to the pre-treatment intervention (MIP and ACC) is computed by
dividing the number of the intervention sessions that an individual participant
has indeed visited and two offered pre-treatment sessions. Adherence to the
rehabilitation treatment is computed by dividing the number of planned
treatment sessions (which amount is tailored to the patients* needs) that an
individual participant has indeed visited by the number of indicated pain
rehabilitation treatment sessions. Level of functioning will be measured by the
Pain Disability Index (PDI) (Pollard 1984) which has shown good psychometric
properties(Chibnall and Tait 1994). It will be used to assess the participants*
self-reported level of functioning and disability resulting from chronic pain.
The PDI rates on an 11-point Likert scale ranging from 0 (no disability) to 10
(total disability) the degree of pain interference with functioning. Seven
areas such as family/ home responsibilities and occupational activity are
assessed. A total score is derived by summing up the item responses, thus the
score range is 0 up to 70. Higher scores indicate more disability (Pollard
1984). A one-factor structure was confirmed and normative data are
available(Chibnall and Tait 1994).
Pain intensity is assessed by a 10-cm Visual Analogue Scale (VAS). The VAS is a
common and valid tool for measuring pain intensity (Revill, Robinson et al.
1976; Carlsson 1983).
Quality of life is also used for the cost-effectiveness analysis (CEA) and the
cost-utility analysis (CUA) of research question 3. It is described there.
Credibility and expectancy is measured by the Credibility and Expectancy
Questionnaire (CEQ)(Devilly and Borkovec 2000). The CEQ demonstrated good
psychometric properties(Devilly and Borkovec 2000).
General self-efficacy is assessed by the Dutch General Self-efficacy
questionnaire(Schwarzer and Jerusalem 1995).
In order to evaluate the change of the participants* self-reported main
complaints, those are assessed by the questionnaire Patient Specific Complaints
(PSC)(Köke 2007) (Beurskens, de Vet et al. 1999). The participants select from
a list 3 to 5 most important physical health complaints related to chronic
pain(Beurskens, de Vet et al. 1999). It is sufficiently tested for patients
with chronic musculoskeletal pain(Beurskens, de Vet et al. 1996).
Secondary outcome 2nd research question
Acceptance, flexible goal-adjustment, pain catastrophizing, pain-related fear
(kinesiophobia), and depression are additionally taken into account as possible
mediators of the relationship between (pre)treatment and outcome.
Acceptance is assessed by the 10-item Acceptance and Action Questionnaire-II
(AAQ-II)(Bond and Hayes in preparation). The Dutch version has shown a high
internal consistency and a good validity(Jacobs, Kleen et al. 2008). Answers
have to be given on a 7-point Likert scale ranging from *never be true* up to
*always true*.
Flexible goal-adjustment (FGA), an component of psychological flexibility is
measured with the Tenacious Goal Pursuit and Flexible Goal Adjustment Scale
Brandstädter and Renner Questionnaire(Brandtstadter and Renner 1990). The scale
describes the tendency to adjust personal goals and standard to situational
limitations. It consists of 15 items with belonging five possible answers
ranging from *totally agree* up to *not agree at all*. Therefore, total scores
range from 0 to 60. The scale*s internal consistency is satisfactory ( *=
0.80)(Brandtstadter and Renner 1990).
Pain-catastrophizing is assessed by the Pain Catastrophizing Scale-Dutch
version (PCS-DV). 13 statements (items) have to be scored on a 5-point Likert
scale ranging from 0 (*not at all*) to 4 (*always*). An example of a statement
is: *I anxiously want the pain to go away.* The total score is calculated by
summing up the scores of the three subscales. The PCS has shown good
psychometric characteristics (Osman, Barrios et al. 2000; Van Damme, Crombez et
al. 2002), this is also valid for the Dutch version (DV).
Pain-related fear is measured by the Tampa Scale of Kinesiophobia (TSK). The
TSK is developed to measure fear of movement/(re)injury during movement. It
consists of 17 statements which have to be rated on a 4-point Likert scale
ranging from *strongly disagree* to *strongly agree*. The TSK has predictive
validity and is sufficient reliable (* =.77). The scale*s psychometric
properties are good(Swinkels-Meewisse, Swinkels et al. 2003).
Depression is assessed by the Becks Depression Inventory (BDI)(Beck, Steer et
al. 1988; Beck and R.A. 1993). The BDI is a well-known in pain research and a
reliable, valid and widely used instrument(Beck, Steer et al. 1988).
Background summary
Chronic non-specific musculoskeletal pain is a major health burden. It occurs
in approximately 10% of the general population(Gran 2003) and causes
disability(Badley, Webster et al. 1995), medical expenses(Meerding, Bonneux et
al. 1998) and a high amount of work absenteeism(Koes, van Tulder et al. 2006).
Nowadays, medication, exercise, and behavioural therapy are mostly used in
management of non-specific musculoskeletal pain.
In the latest decennia, more evidence came available supporting the positive
effect of behavioural therapy in chronic pain. The main assumption underlying
the approach of behavioural therapy is that pain and resulting disability are
not only influenced by biomedical factors, but also by psychological and social
factors. In treatment, to this is referred as biopsychosocial approach(Gatchel,
Peng et al. 2007). Therefore, the ultimate goal of behavioural therapy is to
alter maladaptive thoughts, feelings, and behaviours in order to influence
disability by increasing the level of functioning. The primary aim of
rehabilitation treatment, based on cognitive behavioural therapy, is thus to
learn to cope with pain and not curing pain with the intention to increase a
patients level of participation in society and his/her quality of life..
In order to obtain this, rehabilitation will focus on teaching the patient to
influence his/ her health state positively and getting insight in the relation
between complaints and the circumstances in which they occur (Köke 2005).
However, in order to be effective, behavioural treatment needs cooperation of
both the patient and the practitioner, and the adherence of the patient.
Unfortunately, in the current rehabilitation care, non-adherence and drop-out
are major problems. Adherence has been defined by the WHO as *the extent to
which a person's behaviour * taking medication, following a diet, and/or
executing lifestyle changes- corresponds with agreed recommendations from a
health-care provider(Sabate 2003).
Adherence rates are low in patients with chronic conditions(Sabate 2003) and
subsequently drop-out in pain rehabilitation programmes is high . Drop out
ranges from 9-42% (Peters, Large et al. 1992; Rainville, Ahern et al. 1993;
Bendix, Bendix et al. 1998).
It is known that adherence is influenced by multiple factors such as the health
care provider- patient relationship, the patient*s self-efficacy to be able to
make changes (Bandura 1997), and patients* satisfaction with improvement
(Hirsh, Atchison et al. 2005).
Predictors for drop-out in low back pain rehabilitation are high level of pain
severity (Carosella, Lackner et al. 1994; Lansinger, Nordholm et al. 1994),
patients* beliefs and expectations about the success of a given
treatment(Sloots, Dekker et al. 2010; !!! INVALID CITATION !!!), being less
active in sports(Bendix, Bendix et al. 1998), having a high number of sick
leave days before the start of the treatment (Carosella, Lackner et al. 1994;
Lansinger, Nordholm et al. 1994; Bendix, Bendix et al. 1998), and a lower
age(Carosella, Lackner et al. 1994) are all predictors for drop out.
Previous research showed that adherence and non-drop-out to treatment is
related to a better outcome in physical and emotional functioning and pain
severity (Curran, Williams et al. 2009).
In order to improve adherence and motivation to prevent drop-out, motivational
interviewing (MI) has been proposed. MI was originally developed for problem
drinkers(Miller 1983) and in the beginning applied in the addiction field only
(e.g. (Skutle and Berg 1987; Heather, Rollnick et al. 1996). Miller and
Rollnick, the founders of MI, defined it as *directive, client-centred
counselling style for eliciting behaviour change by helping clients to explore
and resolve ambivalence*(Miller and Rollnick 1991). The overall goal is to
increase the clients* intrinsic motivation to change and enhance behavioural
change(Mesters 2009). A review on working mechanisms in MI found evidence for
three constructs: Firstly, change talk and clients* experience of discrepancy
was related to better outcomes. Secondly, therapist MI-inconsistent behaviour
was related to worse outcomes. Thirdly, the use of a decisional balance
exercise showed also a strong association to better outcomes (Apodaca and
Longabaugh 2009).
Nowadays, MI has also been applied in some studies with chronic pain
conditions. Habib et al. (2005) found significantly increases in participation
after a 2-session Motivational interviewing (MI)-based feedback interview
compared with an attention placebo interview in chronic pain patients(Habib,
Morrissey et al. 2005). Another recent study found an MI-adapted intervention
added to physiotherapy in the treatment of chronic low back pain effectively
enhancing motivation and exercise compliance compared to physiotherapy
alone(Vong, Cheing et al. 2011). In 2010, a Cochrane review in interventions
to improve adherence in chronic musculoskeletal pain indicated that those who
got an exercise programme containing an additional motivation programme were
more likely to attend the exercise classes(Jordan, Holden et al. 2010).
At this moment, no evidence is available in patients with chronic non-specific
musculoskeletal pain in the rehabilitation setting. Those patients are
characterized by a high level of disability and complex problems, mostly of
psychosocial origin.
As meta-analyses ranging from applications ranging for addiction-related
problems to parenting skills showed that using MI as a pretreatment*wherein MI
was designed to prepare clients for further treatment such as
cognitive-behavioral therapy (CBT) or an inpatient program*yielded the best
outcomes (Burke, Arkowitz et al. 2003; Hettema, Steele et al. 2005; Lundahl and
Burke 2009).
In this project MI is introduced as an add- on intervention before a
rehabilitation programme for patients with chronic musculoskeletal pain. The
project has 3 major goals.
First, we want to know whether MI, when used as add-on to a rehabilitation
programme will lead to better adherence to treatment and less drop-out and as a
consequence to better patient outcome. The (cost-) effectiveness of MI will be
compared to an attention control.
Second, since MI is fairly new in chronic pain rehabilitation, the goal is to
get insight into the working elements of MI in this setting. Depression, pain
catastrophizing, pain related fear, treatment expectancy and credibility,
acceptance, flexibility, motivation and treatment integrity are seen as
possible mediators for MI. Partly because these were found previously for
exposure and cognitive behavioural treatment for chronic pain (pain
catastrophizing, pain related fear, flexibility, expectancy and
credibility(Goossens, Vlaeyen et al. 2005; Smeets, Vlaeyen et al. 2006; Leeuw,
Houben et al. 2007; Smeets, Beelen et al. 2008), and partly because these are
identified as the basis elements of MI (motivation, change talk, etc.)
(Apodaca and Longabaugh 2009).
Third goal is to assess the fidelity of the MI, since the impact of MI largely
depends on performance of the MI intervention (Glasziou, Chalmers et al. 2010).
Thereby, also satisfaction of both clients and practitioners, client
centeredness are important factors to take into account(Emmons and Rollnick
2001).
Study objective
The primary objective of this current project is to study the (cost-)
effectiveness of Motivational interviewing in non-specific musculoskeletal
chronic pain patients who are indicated for pain rehabilitation treatment. It
is hypothesized that an MI-based intervention facilitates the patients*
preparedness regarding rehabilitation treatment following the biopsychosocial
approach in terms of expectations and motivation.
As we are as well interested in the improvement of adherence and a decrease of
drop-out in pain rehabilitation and in participation and functioning after
rehabilitation, our study consists of two phases which each have different main
purposes. During phase one, the pre-treatment phase till the standard
screening, we are especially interested in the amount of drop-out caused by the
patient and by means of the subsequent multiprofessional screening, and the
level of the patient*s motivation. In the second phase, the follow-up, we are
especially interested to evaluate participation and functioning.
The main research questions are:
1. What is the effectiveness of MIP(MI-based pre-treatment), compared to ACC
(attention control condition) as an add-on to pain rehabilitation in terms of
participation and treatment drop-out in patients with chronic non-specific
musculoskeletal pain?
3. What are the mediating mechanisms of MIP versus ACC as an add-on to pain
rehabilitation in patients with chronic non-specific musculoskeletal pain?
2. What is the cost-effectiveness of a MI-based pre-treatment (MIP), compared
to control ACC (attention control condition) as an add-on to pain
rehabilitation from a societal perspective?
4. What is the feasibility of the MIP intervention in terms of MI-fidelity
(process evaluation)?
5. What are experiences of nurses, rehabilitation consultants and patients in
terms of satisfaction with and barriers of the MIP intervention (process
evaluation)?
Study design
The PREPARE study is a single-blind randomized controlled trial with a total
follow-up of six months. The study will take place in two departments of
rehabilitation medicine; one academic hospital (Maastricht University Medical
Centre, MUMC+) and one hospital for regional care (Atrium hospital Heerlen). To
understand the unique features of the ACC and MIP conditions, below first the
usual practice in the pain rehabilitation will be explained.
Usual practice in pain rehabilitation
In the usual practice in pain rehabilitation, patients will be selected for
rehabilitation treatment by the consultant in rehabilitation medicine. In
patients with insufficient knowledge about chronic pain, the consultant in
rehabilitation medicine provides additionally more information about the
aetiology, treatment and prognosis of chronic non-specific musculoskeletal pain
based on the book *Mastering pain* (in Dutch: *De pijn de baas*)(Winter 2008).
In order to judge a patient*s readiness for behavioural rehabilitation at the
intake interview, the consultant in rehabilitation medicine will evaluate
whether (1) medical and/or (2) motivational aspects are present and whether
these will interfere with treatment progress (step 1). Additionally, a
questionnaire about pain status, pain-related fear and other topics is taken at
the intake moment.
The medical aspects evaluated are the origin and severity of the pain problem
and the seriousness of interfering co-morbidity. In case to the consultant*s
opinion, a medical or motivational reason is present that seems contra
productive during treatment, the consultant will renounce rehabilitation
treatment. A patient with a medium to high level of motivation will be
indicated for pain rehabilitation.
Between step 1 and 2 patients will be placed at a waiting list for on average
12 weeks.
At step 2, a standard multiprofessional screening for pain rehabilitation will
take place. At these screening, different professionals such as occupational
therapists, physiotherapists and psychologists evaluate the situation of the
patient. Additionally, questionnaires such as about the severity of the pain,
psychiatric co morbidity and pain-related fear are taken. The screening will
result in an indication for pain rehabilitation or a reference outside the pain
rehabilitation. At step 3 finally the rehabilitation can start. Directly after
the treatment and after three months follow-up, other questionnaires are taken
by the patient for evaluative reasons.
The situation during the PREPARE study
In the PREPARE study, the situation as illustrated in figure 1 will be hold.
The unique feature of the PREPARE study is that it adds on a pre-treatment
before the ultimate decision for rehabilitation during the standard
multiprofessional screening between step 1 and 2.
Instead of the consultant in rehabilitation medicine who gives education, this
is delegatded to a trained nurse. Figure 2 illustrates the situation during the
PREPARE study.
To standardize and facilitate the motivation criterion, a 10-point Visual
Analogue Scale (VAS) will be used to mark the patients* motivation for pain
rehabilitation. Patients with a medium to high level of motivation will be
asked for a written consent to receive further information about the PREPARE
study.
In the case of written consent, the study team will provide the patient with
further information about the PREPARE study.
After informed consent of the participant and the baseline measurement, the
participant is randomized to receive either MIP or ACC. For a detailed
description of both interventions see section *treatment of subjects*.
During the waiting-list period, patients will receive the ACC or MIP
intervention in order to prepare them for rehabilitation treatment.
Assessment periods
For the (cost-)effectiveness evaluation, measurements will be carried out at
baseline (T0), after the MIP/ ACC (T1), after the multiprofessional screening
(T2), after finishing pain rehabilitation treatment (T3) and six months after
finishing rehabilitation (T4) (research question 1-3). To take into account
drop-out from and adherence to the (pre-) rehabilitation treatment, process
measures such as start date of the treatment and no show are also taken by the
means of the administrative patient registry. Cost measurements will be carried
out at three moments; T0, T2 and T4.
At T0 and T3, other questionnaires are added to the existing standard set of
questionnaires which have to be undertaken by the patient.
The current study is divided in two parts, phase 1 and phase 2. Phase 1
consists of the two pre-treatment sessions (either MIP or ACC) and the standard
multiprofessional screening.
As we are focusing on a suitable preparation for patients who are probably
ambivalent regarding the bio psychosocial approach of behavioural pain
rehabilitation treatment, the number of patients who are finally indicated for
rehabilitation by the screening is of great interest (phase 1). Also loss to
follow up during pre-treatment, and non-adherence to as well our pre-treatment
intervention as the treatment, are for us of interest. Also, as an indirect
effect, in the patient*s level of motivation we are interested.
Loss to follow up during treatment, non-adherence to as well our study as the
treatment, and drop-out during the rehabilitation treatment are *additionally
to our primary outcome measure participation - important process measures
(phase 2).
Intervention
Common features of the MIP (intervention condition) and ACC (control condition)
are that the participant is invited for two appointments with a nurse at the
rehabilitation department. The duration of the two sessions in both conditions
is approximately 45 minutes up to 1 hour.
Unique features of the MIP intervention condition
The four general principles of MI are incorporated into all sessions in the
MIP- condition. These four general principles of MI are:
1. expressing empathy by the use of reflective listening,
2. developing discrepancy between client goals and current problem behaviour,
3. rolling with resistance by avoiding argumentation by assuming that the
client is responsible for the decision to change,
4. and supporting self-efficacy and optimism for change(Emmons and Rollnick
2001).
The content of each of the appointments is individually tailored to the
patients* readiness to change. This means that the nurse is instructed to
respond in a proper way upon the actual stage of motivation of the patient
which is measured by a checklist before the first session and also will become
obvious during the session.
The nurse is directive within this process, but the patients* autonomy is
strengthened and his or her right to decide is respected.
During the 1st appointment, a trustful relationship between patient and nurse
is built, the actual (life) situation, burden and impairments of the chronic
pain in daily life, motivation, self-efficacy, and readiness to change for
behaviour change is assessed and enhanced, the session is summarized and closed.
The 2nd appointment is a brief Motivational feedback session. The process of
the 1st appointment will be discussed with the participant by giving feedback
adapted to the state of readiness- to- change. Therein, motivation and
self-efficacy for behaviour change is enhanced. In addition, topics related to
chronic pain and treatment, such as education about the influence of exercise
and a back ground in the bio psychosocial approach be part of the MIP
intervention. Then, the session is summarized and closed.
Unique features of the ACC control condition
In the control condition patients will receive pain education according to the
information in the book *De pijn de baas*(Winter 2008) (mastering pain). In
current care, education based on information provided in *de pijn de baas* is
already part of the treatment and is provided by the consultant. However,
literature shows that patients with chronic pain benefit are less likely to
benefit from education compared with pain patients in an acute (or short-term)
state(Engers, Jellema et al. 2008). The ultimate goal of the attention control
condition (ACC) is to provide the participant with information.
The content of the two sessions is as follows:
The 1st session starts with a general health education about topics related to
chronic pain and treatment which are also part of the *Mastering pain*-book.
The 2nd session is guided by the same book about chronic pain and pain
rehabilitation. Also information is provided regarding core elements of pain
rehabilitation such as the bio psychosocial approach inherent rehabilitation
treatment and the importance to exercise. Contrary to the MIP condition, no
feedback is given related to the stage of change of the participant.
Study burden and risks
Patients who are participating in the study need to complete questionnaires
with regard to effect evaluation, cost-effectiveness evaluation, and process
evaluation at 5 moments (T0, T1, T2, T3, and T4). Some questionnaires are
currently already part of usual care, whereas others are integrated for this
study only. To complete the questionnaire T0 and T2, T3, T4, 45 minutes are
required. T1 takes 20 minutes.
Posbus 616
6200 MD Maastricht
Nederland
Posbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Non-specific chronic musculoskeletal pain syndrome.
Pain duration >3 months [16].
Age between 18 and 65 years.
Eligible and (as yet) indicated for outpatient pain rehabilitation treatment, main indication criteria: chronic pain.
Medium to high level of motivation for pain rehabilitation from the consultant*s perspective.
The chronic pain syndrome is not attributable to a recognisable, known specific pathology (e.g. infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis), radicular syndrome or cauda equina syndrome)
Adequate literacy to complete assessment measures.
Exclusion criteria
Pregnancy
Surgery planned in the foreseeable future.
Patient involved in litigation procedures.
Psychopathology which makes the indication for the pain rehabilitation treatment impossible.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36029.068.11 |
| Other | TC= 2841 |