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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37696
Enrollment
160
Registered
2011-11-28
Start date
2012-01-31
Completion date
Unknown
Last updated
2024-05-06

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

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

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 65 years. Eligible and indicated for outpatient pain rehabilitation treatment as it turns out from the main indication criteria: Non-specific chronic (pain duration >3 months) musculoskeletal pain syndrome. And sufficient motivation for pain rehabilitation from the consultant). 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. 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 difference in change in level of participation of the participants at 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). 2nd research question (cost-effectiveness and cost-utility To evaluate the economic effects of MIP and UC, relevant cost categories of resource use and volumes of these categories must be measured. Finally, volumes have to be multiplied by the belonging costs. According to the principles of economic evaluations for interventions of chronic musculoskeletal pain by Goossens et al., (1999), the following cost categories will be included. 1) Direct health care costs inside which include the costs of the pain rehabilitation treatment and the pain-related health care utilisation during the follow-up period; 2) Direct costs outside the health sector which include costs of (un)paid help, out-of pocket expenses, and travel costs of attending the pain rehabilitation treatment; and 3) Indirect costs outside the health sector, which include production losses (absenteeism) due to the chronic pain problem (Hakkaart- van Roijen, Tan et al. Geactualiseerde versie 2010). To analyse differences in costs, costs per patient-year will be calculated. This means that the observed cos

Secondary

MeasureTime frame
Secondary study parameters focused on the goal of activity-based cognitive-behavioral pain rehabilitation are level of functioning, pain intensity, pain-catastrophizing, pain-related fear, patient-related complaints, depression, credibility and expectancy, acceptance, and flexible goal-adjustment. Secondary study parameters focused on the immediate goal of the pre-treatment are adherence to the pre-treatment, drop-out, motivation, and self-efficacy. Study parameters focused on the process of the intervention are feasibility in terms of a) integrity and b) fidelity of the intervention, and satisfaction with the pre-pain rehabilitation treatment and the pain rehabilitation treatment in patients, nurses and consultants in rehabilitation medicine.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)