Failed Back Surgery Syndrome, Spinal Cord Stimulation
Conditions
Brief 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.
Detailed 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.
Interventions
OTHERUsual Care trajectory
Usual care after Spinal Cord Stimulation implantation
OTHERA biopsychosocial rehabilitation program
A personalized biopsychosocial rehabilitation program specifically targeting return to work.
Sponsors
Vrije Universiteit Brussel
University Ghent
KU Leuven
Moens Maarten
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work ability | 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. | Work ability, evaluated with the Work Ability Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional disability | 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. | The functional disabilities will be assessed with the Oswestry Disability Index (ODI). |
| Functional capacity evaluation | 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. | Functional capacity evaluation will be performed using a shortened version of the Isernhagen Work Systems. |
| Work status and participation | 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. | Work Rehabilitation Questionnaire will be used to evaluate functioning in Vocational Rehabilitation |
| Overall pain intensity with Visual Analogue Scale (VAS) | 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, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm). |
| Health related quality of life | 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, evaluated with the EuroQol with five dimensions and 5 levels. |
| Sleep quality | 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. | Perceived sleep quality will be measured with the Pittsburgh Sleep Quality Index. |
| 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. | The Tampa Scale for Kinesiophobia will be used to measure kinesiophobia. |
| Healthcare utilisation | The change in healthcare utilisation starting from the the baseline screening up to 12 months after the intervention. | Healthcare expenditure will be investigated by self-reporting methods. |
| 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. | The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression. |
| Patients' individual competencies for self-management | 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. | 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. |
| Physical activity | The change between the baseline screening and the evaluation immediately after the intervention, 6 months after the intervention and 12 months after the intervention. | Physical activity will be objectively measured with actigraphy. |
Countries
Belgium
Contacts
Primary ContactMaarten Moens, Prof. dr.
Backup ContactLisa Goudman, PhD
Outcome results
None listed