Failed Back Surgery Syndrome Clinical Trial
— OPERAOfficial title:
Objectifying Performance Assessments and Personalized Rehabilitation Trajectories to Improve Return to Work in Patients With Persistent Spinal Pain Syndrome Type II: a Randomized Controlled Trial.
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 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Moens Maarten | KU Leuven, University Ghent, Vrije Universiteit Brussel |
Belgium,
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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