Evaluation of a proactive program to prevent chronic pain, fatigue and/or dizziness

1. Background

Medically unexplained physical symptoms (MUPS) are an important health problem in primary
care, with a spectrum from mild to chronic. The burden of chronic MUPS is substantial for
patients, health care professionals and society. Therefore, early identification of patients with
moderate MUPS is needed, enabling prevention of chronicity. We developed the PRESUME
screenings method using data from the electronic medical record of the general practitioner and
demonstrated its prognostic accuracy to identify patients with moderate MUPS. In the next step
we developed a proactive blended and integrated mental health and physiotherapy intervention
program (PARASOL), to reduce complaints of moderate MUPS, stimulate self-management and
prevent chronicity. The primary objective of this study is to investigate the effectiveness of the
blended PARASOL intervention on the impact of symptoms and quality of life in patients with
moderate MUPS compared with usual care.



2. Research questions

1. What is the effectiveness of the PARASOL intervention on impact of symptoms and physical
and mental dimensions of quality of life in patients with moderate MUPS compared with usual
care?

2. What is the influence of the PARASOL intervention on severity of symptoms, general health,
physical behaviour, illness perception and self-efficacy in patients with moderate MUPS
compared with usual care?

3. What is the cost-effectiveness of the PARASOL intervention in patients with moderate MUPS
compared with usual care?



3. Study design

We will perform a multicenter cluster randomized clinical trial. Adult patients with moderate
MUPS will be identified in electronic medical record data using the PRESUME screening and
proactively recruited for participation in the study. Cluster randomization will be performed at the
level of the participating health care centers. In total 248 patients with moderate MUPS (per arm
124 patients) are needed. The PARASOL intervention is a 12-week blended primary care
program consisting of four face to face consultations with the mental health nurse and five
physiotherapy sessions, supplemented with a web-based program. The web-based program
contains of (1) information modules and video’s on self-management and educative themes, (2)
video’s and instructions on prescribed home exercises and (3) assignments to gradually
increasing physical activity program. The program is directed at patients’ perception of
symptoms, and modifiable prognostic risk factors for chronicity using therapeutic neuroscience
education and encouraging self-management as well as an active lifestyle using a cognitive
behavioural approach and graded activity. Primary outcomes are impact of symptoms and
quality of life. Secondary outcomes are severity of (psychosocial) symptoms, general health,
physical behaviour, illness perceptions, self-efficacy and cost-effectiveness. All measurements
will be performed at baseline, three and twelve months after baseline. Retrospective cost
questionnaires will also be sent at six and nine months after baseline, used for the cost-
effectiveness analysis.

Medically unexplained physical symptoms (MUPS) are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic MUPS is substantial for patients, health care professionals and society. We developed a proactive blended and multidisciplinary preventive intervention to reduce complaints of moderate MUPS and to prevent chronicity, called the PARASOL intervention. It is hypothesised that the PARASOL intervention can reduce impact and severity of symptoms and increase quality of life, general health, physical behaviour, illness perception and self-efficacy in patients with moderate MUPS.

Three moments (0, 3 and 12 months) will be used for data collection. In addition, cost questionnaires will also be sent at 6 and 9 months. Furthermore, impact of symptoms will be measured weekly between 0 and 3 months, and monthly between 6 and 12 months.

The PARASOL intervention is a 12-week blended primary care program consisting of four face to face consultations with the mental health nurse and five sessions of physical therapy, supplemented with a web-based program.



The control group will get care as usual without any restrictions.