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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| UHasselt | UNKNOWN |
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To compare the current rehabilitation pathway with the implementation of a newly developed rehabilitation pathway for patients with a single and double level lumbar arthrodesis.
This involves a prospective interventional study with a one year follow-up. The investigators will compare the outcomes of the current rehabilitation pathway with a newly developed (based on systematic review and delphi study) rehabilitation pathway for patients with a single and double level lumbar arthrodesis. The usual care group (n= 30) will be compared with the intervention group (n= 30).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | usual care |
|
| Intervention group | Experimental | Rehabilitation with a biopsychosocial focus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation with a biopsychosocial focus | Behavioral | Rehabilitation with a biopsychosocial focus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 1 week |
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 6 weeks |
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 3 months |
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 6 months |
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating scale (NRS) | Severity of low back pain will be scored by the Numerical Rating Scale (NRS) from zero ('no pain') to ten ('worst pain imaginable') (Jensen, M.P., Karoly, P., Braver, S. (1986). The measurement of clinical pain intensity: a comparison of six methods. Pain 27, 117-126.) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bart Depreitere, PhD, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Thijs Swinnen, MSc, PT | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Tinne Thys, MSc, PT | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Wim Dankaerts, PhD, PT | KU Leuven | Principal Investigator |
| Simon Brumagne, PhD, PT | KU Leuven | Principal Investigator |
| Peter Van Wambeke, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Lieven Moke, PhD, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Sebastiaan Schelfaut, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Ann Spriet, MSc, PT | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ/KU Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Control group | Behavioral | usual care |
|
| Tampa scale for Kinesiophobia (TSK) | The Tampa Scale for Kinesiophobia (TSK), which ranges from 17 ('low') to 68 ('high'), was completed to identify fear of (re)injury following movements or activities in the participants with low back pain (Kori, K.S., Miller, R.P., Todd, D.D. (1990). Kinesiophobia: A new view of chronic pain behaviour. Pain 3, 35-43.) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |
| Pain Catastrophizing scale (PCS) | People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness. | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |
| Depression Anxiety stress scale (DASS) | A higher score on the DASS indicates greater severity or frequency of negative emotional symptoms, ranging from 0-126. | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |
| EuroQol five dimensions questionnaire (EQ-5D) | questionnaire measuring general health | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |
| Sit-to-stand | time to perform 5 times sit-to-stand-to-sit | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |
| Patient Specific Functional Scale (PSFS) | The PSFS is a questionnaire measuring disability related to low back pain. The Scale is developed by "Stratford, P., Gill, C., Westaway, M., & Binkley, J. (1995). Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada, 47, 258-263." Three to five activities are scored on a Visual Analogue Scale (VAS) from 0 ('not able to perform activity') to 10 ('can perform activity without any problems'). Lower scores indicate a worse outcome on function. The total score is the sum of the VAS scores of the 3 to 5 activities. | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |
| Return-to-work | questionnaire on work resumption | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |
| Lotte Janssens, PhD, PT |
| Hasselt University |
| Principal Investigator |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |