Spinal Disease Clinical Trial
— CHAPARSOfficial title:
Baseline-characteristics of Patients Referred to a Secondary Spine Centre
NCT number | NCT04877470 |
Other study ID # | Z2021026 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 24, 2021 |
Est. completion date | May 1, 2023 |
Verified date | February 2024 |
Source | Zuyderland Medisch Centrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A retrospective cohort study will be conducted in Zuyderland Medical Centre Heerlen, the Netherlands. All patients that were referred to the spine-centre between 01.01.2019 and 31.12.2019 will be included for analysis. This study aims to evaluate baseline characteristics, including baseline questionnaires, and information about the given treatments for all patients referred to the spine centre.
Status | Completed |
Enrollment | 4855 |
Est. completion date | May 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Newly referred patients visiting the spine-centre at Zuyderland Medical Centre Heerlen in 2019, from 01.01.2019 until 31.12.2019. - Minimum age of 18 years. - Documented treatment (surgical or conservative). Exclusion Criteria: - Documented objection to participate in scientific research. - No baseline questionnaires available |
Country | Name | City | State |
---|---|---|---|
Netherlands | Zuyderland MC | Heerlen | Limburg |
Lead Sponsor | Collaborator |
---|---|
Zuyderland Medisch Centrum |
Netherlands,
de Kunder SL, Rijkers K, Caelers IJMH, de Bie RA, Koehler PJ, van Santbrink H. Lumbar Interbody Fusion: A Historical Overview and a Future Perspective. Spine (Phila Pa 1976). 2018 Aug;43(16):1161-1168. doi: 10.1097/BRS.0000000000002534. — View Citation
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Saifi C, Cazzulino A, Laratta J, Save AV, Shillingford JN, Louie PK, Pugely AJ, Arlet V. Utilization and Economic Impact of Posterolateral Fusion and Posterior/Transforaminal Lumbar Interbody Fusion Surgeries in the United States. Global Spine J. 2019 Apr;9(2):185-190. doi: 10.1177/2192568218790557. Epub 2018 Aug 15. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Age | Age in years. | 01.01.2019-31.12.2019 | |
Primary | Gender | Male, female, other | 01.01.2019-31.12.2019 | |
Primary | Body Mass Index (BMI) | BMI = kg/m2 | 01.01.2019-31.12.2019 | |
Primary | Smoking (current status) | Yes/no | 01.01.2019-31.12.2019 | |
Primary | Duration of symptoms | Time since onset of symptoms in months. | 01.01.2019-31.12.2019 | |
Primary | Type of complaints | Back pain, leg pain, arm pain or neck pain | 01.01.2019-31.12.2019 | |
Primary | Diagnosis | Final diagnosis as mention in the patient file, e.g. lytic spondylolisthesis, herniated disc etc. | 01.01.2019-31.12.2019 | |
Primary | History of spinal surgery | Spinal surgeries in the past, as mentioned in the patient file, e.g. lumbar interbody fusion, discectomy, etc. | 01.01.2019-31.12.2019 | |
Primary | Use of pain medication | Paracetamol, NSAID, opioid, neuropathic pain medication | 01.01.2019-31.12.2019 | |
Primary | Reason for referral | Reason for referral, as mentioned in the general practitioner's file, e.g. persistent back pain, leg pain, etc. | 01.01.2019-31.12.2019 | |
Primary | Diagnostics tests carried out | Diagnostics as mentioned in the patient file, e.g. MRI, CT-scan, X-ray, EMG, etc. | 01.01.2019-31.12.2019 | |
Primary | Number of consultations | Number of consultations at the spine-centre since referral. | 01.01.2019-31.12.2019 | |
Primary | Follow-up period | Time between the first consultation and the last follow-up consultations, in months. | 01.01.2019-31.12.2019 | |
Secondary | EuroQol 5D | Score per item, total score is based on Value Sets. A lower score indicated a better quality of life. | 01.01.2019-31.12.2019 | |
Secondary | Roland Disability Questionnaire | Score: 0-24. A higher score indicated more disability. | 01.01.2019-31.12.2019 | |
Secondary | Tampa Scale of Kinesiophobia | Score: 17-68. 17 means no kinesiophobia, 68 means severe kinesiophobia | 01.01.2019-31.12.2019 | |
Secondary | Visual Analogue Scale (VAS) | Score: 0-10. 0 is no pain, 10 is maximum pain | 01.01.2019-31.12.2019 | |
Secondary | Western Ontario and McMaster Universities Osteoarthritis Index | Score: 0-96. A higher score indicates more complaints and disability. | 01.01.2019-31.12.2019 | |
Secondary | Oxford Hip Score | Score: 12-60. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome. | 01.01.2019-31.12.2019 | |
Secondary | Oswestry Disability Index | Score: 0-100 . A higher scores indicated more disability. | 01.01.2019-31.12.2019 | |
Secondary | Örebro Musculoskeletal Pain Screening Questionnaire | Score: 0-210. A higher score indicated more complaints and more disability. | 01.01.2019-31.12.2019 |
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