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The (cost-)effectiveness of PREPARE (Pre-pain rehabilitation) treatment, a Motivational interviewing (MI)-based nurse-led intervention on motivation and adherence for, and participation after pain rehabilitation treatment in chronic non-specific musculoskeletal pain syndrome patients: a randomized controlled trial (RCT).

The (cost-)effectiveness of PREPARE (Pre-pain rehabilitation) treatment, a Motivational interviewing (MI)-based nurse-led intervention on motivation and adherence for, and participation after pain rehabilitation treatment in chronic non-specific musculoskeletal pain syndrome patients: a randomized controlled trial (RCT). - Pre-pain rehabilitation (PREPARE) treatment in chronic pain: a RCT

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36212
Enrollment
194
Registered
2011-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronische aspecifieke musculoskeletale pijn Chronic non-specific musculoskeletal pain

Interventions

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 o

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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 va

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)