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| Name | Class |
|---|---|
| Vrije Universiteit Brussel | OTHER |
| University Ghent | OTHER |
| KU Leuven | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator |
| |
| Personalized biopsychosocial rehabilitation program | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care trajectory | Other | Usual care after Spinal Cord Stimulation implantation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maarten Moens, Prof. dr. | Contact | +3224775514 | stimulusresearchgroup@gmail.com | |
| Lisa Goudman, PhD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Recruiting | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36471349 | Derived | Moens M, Goudman L, Van de Velde D, Godderis L, Putman K, Callens J, Lavreysen O, Ceulemans D, Leysen L; OPERA consortium; De Smedt A. Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study. Trials. 2022 Dec 5;23(1):974. doi: 10.1186/s13063-022-06895-5. |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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| A biopsychosocial rehabilitation program |
| Other |
A personalized biopsychosocial rehabilitation program specifically targeting return to work. |
|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Jessa Ziekenhuis | Recruiting | Hasselt | Belgium |
|
| Universitair Ziekenhuis Brussel | Recruiting | Jette | 1090 | Belgium |
|
| AZ Nikolaas | Not yet recruiting | Sint-Niklaas | Belgium |
|
| AZ Turnhout | Not yet recruiting | Turnhout | Belgium |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |