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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05269212
Other study ID # OPERA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2022
Est. completion date August 2025

Study information

Verified date May 2022
Source Universitair Ziekenhuis Brussel
Contact Maarten Moens, Prof. dr.
Phone +3224775514
Email stimulusresearchgroup@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work (RTW) compared with usual care.


Description:

A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work compared with usual care. The primary scientific objective is to examine whether the ability to work in PSPS-T2 patients after SCS implantation is different with a personalized biopsychosocial rehabilitation program specifically targeting RTW, compared to usual care. The secondary objective of the study is to examine if a personalized biopsychosocial rehabilitation program specifically targeting RTW, compared to usual care, is different in improving functional capacity, improving work status and participation, obtaining pain relief, increasing health-related quality of life, increasing functioning and physical activity, improving sleep quality, decreasing kinesiophobia, increasing self-management, decreasing anxiety and depression and decreasing healthcare expenditure. Patients will be randomly allocated (1:1 ratio) to a personalized rehabilitation program or usual care using random, permuted blocks of 2 or 4 patients stratified by investigational site and the duration of sick leave. Participants randomly allocated to the usual care intervention will undergo the usual care trajectory. This program is delivered at each of the participating centres. Patients will follow the usual care as it is implemented in Belgian hospitals, after SCS implantation. Participants randomly allocated to the personalized biopsychosocial return to work program will receive an individualized 14-week rehabilitation program. Therapy is provided at each implantation centres and will start 6 weeks after definitive SCS implantation. Within a 14-week period, patients in this group receive treatment sessions from trained physiotherapists, occupational therapists and psychologists. All therapists will be trained by experts in the different therapy modalities. Outcome assessments will take place at baseline, immediately before the intervention, immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 112
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Persistent Spinal Pain Syndrome Type II (PSPS-T2) - Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment. - Dutch speaking persons - Patient has been informed of the study procedures and has given written informed consent - Patient willing to comply with study protocol including attending the study visits Exclusion Criteria: - Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma). - Pregnancy

Study Design


Intervention

Other:
Usual Care trajectory
Usual care after Spinal Cord Stimulation implantation
A biopsychosocial rehabilitation program
A personalized biopsychosocial rehabilitation program specifically targeting return to work.

Locations

Country Name City State
Belgium UZ Gent Gent
Belgium Jessa Ziekenhuis Hasselt
Belgium Universitair Ziekenhuis Brussel Jette
Belgium AZ Nikolaas Sint-Niklaas
Belgium AZ Turnhout Turnhout

Sponsors (4)

Lead Sponsor Collaborator
Moens Maarten KU Leuven, University Ghent, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Work ability Work ability, evaluated with the Work Ability Index The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Functional capacity evaluation Functional capacity evaluation will be performed using a shortened version of the Isernhagen Work Systems. The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Work status and participation Work Rehabilitation Questionnaire will be used to evaluate functioning in Vocational Rehabilitation The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Overall pain intensity with Visual Analogue Scale (VAS) Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm). The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Health related quality of life Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels. The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Physical activity Physical activity will be objectively measured with actigraphy. The change between the baseline screening and the evaluation immediately after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Functional disability The functional disabilities will be assessed with the Oswestry Disability Index (ODI). The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Sleep quality Perceived sleep quality will be measured with the Pittsburgh Sleep Quality Index. The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Kinesiophobia The Tampa Scale for Kinesiophobia will be used to measure kinesiophobia. The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Healthcare utilisation Healthcare expenditure will be investigated by self-reporting methods. The change in healthcare utilisation starting from the the baseline screening up to 12 months after the intervention.
Secondary Anxiety and depression The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression. The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Patients' individual competencies for self-management Patient activation measure-13 (PAM) is a 13-item instrument which assesses self-reported behaviour, knowledge, and confidence for self-management of one's health. The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
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