An observational study in Spine Disease, Characteristics Disease and Spinal Disease, sponsored by Zuyderland Medisch Centrum. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by Zuyderland Medisch Centrum · 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.
The incidence of back and neck pain is increasing in our ageing population. Back pain is amongst the conditions with the highest burden of disease in terms of years lived with disability (YLD). The majority of people experiences at least one period of back pain in their lifetime. The incidence of back complaints increases with age. Due to ageing of the population, the number of patients with back pain exponentially increases. Since 1980, the global population of people older than 60 years has doubled and this number is expected to double again by 2050. Patients with back or neck pain and/or symptoms of radiculopathy, and suspected spinal pathology, are often referred to a secondary spine centre. A large number of these patients will receive conservative treatment and only a small number eventually receives a surgical intervention. There is a broad array of conservative treatment options, including medication, manipulative care, physical therapy, treatment by pain specialists, and rehabilitation. The increasing incidence of spinal pathologies likewise leads to an increase in spinal surgeries. The ageing population is one of the most prominent factors by which the number of spine surgeries has increased and will even increase further in the future. Previous studies concerning the national US bill for spine related care in 2006 estimated that direct medical expenditures were over $85 billion. Over the last decades, the costs of spine related healthcare have increased at an alarming rate and will even increase further. To limit the increase of healthcare-related costs concerning spine-related healthcare in an ageing population, the selection and profiling of subgroups of patients requiring different types of treatment should be ameliorated to optimize spinal care. To date, adequate knowledge on baseline characteristics is lacking, and thereby insufficient to perform patient profiling.
This study aims to evaluate baseline characteristics, including baseline questionnaires, and information about the given treatments for all patients referred to the spine centre. Insight in the specific characteristics of different patient groups, for example different types of conservative interventions or conservative versus surgical interventions, could provide a valuable insight during counselling.
267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.
This study's enrollment of 4,855 is above the median of 108 across 87 observational studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Zuyderland Medisch Centrum is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
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The study population will consist of adult patients who are referred to the spine-centre at Zuyderland Medical Centre
Exclusion Criteria:
Newly referred patients visiting the spine-centre at Zuyderland Medical Centre Heerlen in 2019, from 01.01.2019 until 31.12.2019.
Other: Consultation at spine-centre
All patients who visited the spine-centre for the first time in 2019 are included in this group.
Age
Age in years.
Time frame: 01.01.2019-31.12.2019
Gender
Male, female, other
Time frame: 01.01.2019-31.12.2019
Body Mass Index (BMI)
BMI = kg/m2
Time frame: 01.01.2019-31.12.2019
Smoking (current status)
Yes/no
Time frame: 01.01.2019-31.12.2019
Duration of symptoms
Time since onset of symptoms in months.
Time frame: 01.01.2019-31.12.2019
Type of complaints
Back pain, leg pain, arm pain or neck pain
Time frame: 01.01.2019-31.12.2019
Diagnosis
Final diagnosis as mention in the patient file, e.g. lytic spondylolisthesis, herniated disc etc.
Time frame: 01.01.2019-31.12.2019
History of spinal surgery
Spinal surgeries in the past, as mentioned in the patient file, e.g. lumbar interbody fusion, discectomy, etc.
Time frame: 01.01.2019-31.12.2019
Use of pain medication
Paracetamol, NSAID, opioid, neuropathic pain medication
Time frame: 01.01.2019-31.12.2019
Reason for referral
Reason for referral, as mentioned in the general practitioner's file, e.g. persistent back pain, leg pain, etc.
Time frame: 01.01.2019-31.12.2019
Diagnostics tests carried out
Diagnostics as mentioned in the patient file, e.g. MRI, CT-scan, X-ray, EMG, etc.
Time frame: 01.01.2019-31.12.2019
Number of consultations
Number of consultations at the spine-centre since referral.
Time frame: 01.01.2019-31.12.2019
Follow-up period
Time between the first consultation and the last follow-up consultations, in months.
Time frame: 01.01.2019-31.12.2019
EuroQol 5D
Score per item, total score is based on Value Sets. A lower score indicated a better quality of life.
Time frame: 01.01.2019-31.12.2019
Roland Disability Questionnaire
Score: 0-24. A higher score indicated more disability.
Time frame: 01.01.2019-31.12.2019
Tampa Scale of Kinesiophobia
Score: 17-68. 17 means no kinesiophobia, 68 means severe kinesiophobia
Time frame: 01.01.2019-31.12.2019
Visual Analogue Scale (VAS)
Score: 0-10. 0 is no pain, 10 is maximum pain
Time frame: 01.01.2019-31.12.2019
Western Ontario and McMaster Universities Osteoarthritis Index
Score: 0-96. A higher score indicates more complaints and disability.
Time frame: 01.01.2019-31.12.2019
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.
Time frame: 01.01.2019-31.12.2019
Oswestry Disability Index
Score: 0-100 . A higher scores indicated more disability.
Time frame: 01.01.2019-31.12.2019
Örebro Musculoskeletal Pain Screening Questionnaire
Score: 0-210. A higher score indicated more complaints and more disability.
Time frame: 01.01.2019-31.12.2019
Plan to share: No
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Zuyderland Medisch Centrum