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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
112
Usual care after Spinal Cord Stimulation implantation
A personalized biopsychosocial rehabilitation program specifically targeting return to work.
UZ Gent
Ghent, Belgium
RECRUITINGJessa Ziekenhuis
Hasselt, Belgium
RECRUITINGUniversitair Ziekenhuis Brussel
Jette, Belgium
RECRUITINGWork ability
Work ability, evaluated with the Work Ability Index
Time frame: 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
Functional capacity evaluation will be performed using a shortened version of the Isernhagen Work Systems.
Time frame: 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 status and participation
Work Rehabilitation Questionnaire will be used to evaluate functioning in Vocational Rehabilitation
Time frame: 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).
Time frame: 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.
Time frame: 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.
Lisa Goudman, PhD
CONTACT
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AZ Nikolaas
Sint-Niklaas, Belgium
NOT_YET_RECRUITINGAZ Turnhout
Turnhout, Belgium
NOT_YET_RECRUITINGPhysical activity
Physical activity will be objectively measured with actigraphy.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.