Pre-pain rehabilitation (PREPARE) treatment in chronic pain: a randomized controlled trial (RCT)

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.
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.
As participation is the ultimate goal and key rehabilitation outcome in the
long term, this is also the primary outcome measure of the proposed study. This
is in accordance with the ICF (International Classification of Functioning,
Disability and Health).
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 and motivation of the
patient. 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
Unfortunately, in the current rehabilitation care, non-adherence and drop-out
are major problems. 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).
In order to improve adherence and motivation to prevent drop-out, motivational
interviewing (MI) has been proposed.
Nowadays, MI has also been applied with promising results in twee RCT-studies
within chronic pain conditions. MI as treatment approach is fairly new in the
field of chronic pain,
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.
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).
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).

1. What is the effectiveness of MIP (MI-based pre-treatment) compared to UC
(usual care) on the level of participation and treatment drop-out in patients
with chronic non-specific musculoskeletal pain following pain rehabilitation?
2. What is the cost-effectiveness and cost-utility of a MI-based pre-treatment
(MIP), compared to UC (usual care) from a societal perspective?
3. What are the mediating mechanisms of MIP versus UC in patients with chronic
non-specific musculoskeletal pain?
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)?

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 features of the UC condition, below first the usual practice in
pain rehabilitation will be explained.

Usual practice in pain rehabilitation
In the usual practice in pain rehabilitation, patients are selected for
rehabilitation treatment by the consultant in rehabilitation medicine during an
intake interview. The judgement of a patient*s readiness for behavioural
rehabilitation at the intake interview will be based on expert opinion by the
consultant in rehabilitation medicine.
The intake consists of two parts. 1) Screening whether the patient is a
potential candidate for rehabilitation treatment by the evaluation of both
medical and motivational factors, and in the case of indication for
rehabilitation treatment. 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.
In the case of an indication for rehabilitation treatment, 2) Providing
education on 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) and providing information about the goal of pain
rehabilitation. The education is provided by nurses specialized in the field of
rehabilitation.

As there exists a waiting list lasting on average 12 weeks between the
indication for treatment by the consultant in rehabilitation medicine and the
ultimate start of the treatment, all patients receive the two pain education
sessions provided by nurses during this time.
At the start of the rehabilitation treatment, the first phase of treatment will
take place: the assessment. This phase is aiming for a clear picture about
functional limitations, and the origin of the pain, resulting in a treatment
plan including treatment goals.
This phase starts with a clinical assessment battery. Patients are asked to
fill in a set of questionnaires.
In addition, the patient will be interviewed by different professionals such as
occupational therapists, physiotherapists and/ or psychologists to objectify a
patient*s current situation on the level of impairment, activities and
participation. In addition, interfering personal and environmental factors (see
ICF mentioned before) will be identified.
Finally, the last part of the assessment phase is the preparation of a
treatment plan with concrete treatment goals to work on during treatment.
Post treatment and three months follow up; the clinical assessment battery is
repeated aiming at treatment evaluation.

The situation during the PREPARE study
In the PREPARE study, the situation continues unchanged. The unique feature of
the PREPARE study is that a Motivational Interviewing-based intervention is
compared with the usual care pain education before the ultimate start of the
rehabilitation treatment during the time on the waiting list.
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 an indication for treatment and a medium to high
level of motivation will be asked to sign an interest form to receive 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 UC.
Participants will receive the MIP or UC condition during the period they will
be on a waiting list for treatment. In this way, the actual date for the start
of treatment will be unchanged.

All patients will be invited to come to the rehabilitation department for two
sessions with a nurse at the rehabilitation department.
Total contact time in both conditions is identical. The content of the
conditions is different.

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.
During the 1st appointment, a trustful relationship between participant 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 usual care
In the usual care condition, participants 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 a nurse. The ultimate
goal is to provide the participant with information. Contrary to the MIP
condition, no feedback is given related to the stage of change of the
participant. 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).

Nurses
Both the usual care condition (UC) and the MIP (intervention condition) are
administered by registered nurses working in the field of rehabilitation.
Nurses will guide participants in only one condition, and will thus be trained
to provide only one of the two study conditions. Before the start of the study,
the nurses are extensively trained by different certified trainers in skills
necessary for the intervention condition cq. the control condition.
All the nurses involved in the MIP intervention condition have already been
trained in MI. The nurses selected for delivering the MI condition, are
experienced MI coaches. For this project, their knowledge and experience in MI
in the specific context of chronic pain rehabilitation will be updated. The
training will be tailored to their specific needs and will be provided in an
evidence-based manner to the nurses (Miller, Yahne et al. 2004; Miller and
Moyers 2007; Lane, Hood et al. 2008; Söderlund, Nilsen et al. 2008; Madson,
Loignon et al. 2009). Training will also include intervision during the
project. Therefore, the emphasis of the subsequent training will be on
additionally regular intervision, supervision, training-on-the job and direct
feedback on MIP sessions.
Nurses of the usual care condition will receive a refresher training in general
communication skills and health information. These nurses are selected based on
no prior knowledge about counselling and MI in particular. The training in the
UC condition was provided by a person experienced in the training communication
skills of health professionals. This is another trainer than in the MIP
intervention condition.

In both conditions the nurses will receive a detailed manual that gives
specific instructions for each session.

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). The research-related
assessments at T0 and T3 will be integrated in the clinical assessment battery
of usual care. To complete the questionnaire T0 and T2, T3, T4, 45 minutes are
required. T1 takes 20 minutes.