Clinical trial NCT04877470: Baseline-characteristics of Patients Referred to a Secondary Spine Centre
Official title: Baseline-characteristics of Patients Referred to a Secondary Spine Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Disease
Characteristics Disease
Spinal Disease
Demography
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 4855
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients who are referred to the spine-centre at Zuyderland Medical Centre

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Age
timeFrame: 01.01.2019-31.12.2019
measure: Gender
timeFrame: 01.01.2019-31.12.2019
measure: Body Mass Index (BMI)
timeFrame: 01.01.2019-31.12.2019
measure: Smoking (current status)
timeFrame: 01.01.2019-31.12.2019
measure: Duration of symptoms
timeFrame: 01.01.2019-31.12.2019
measure: Type of complaints
timeFrame: 01.01.2019-31.12.2019
measure: Diagnosis
timeFrame: 01.01.2019-31.12.2019
measure: History of spinal surgery
timeFrame: 01.01.2019-31.12.2019
measure: Use of pain medication
timeFrame: 01.01.2019-31.12.2019
measure: Reason for referral
timeFrame: 01.01.2019-31.12.2019
measure: Diagnostics tests carried out
timeFrame: 01.01.2019-31.12.2019
measure: Number of consultations
timeFrame: 01.01.2019-31.12.2019
measure: Follow-up period
timeFrame: 01.01.2019-31.12.2019
Secondary outcomes:
measure: EuroQol 5D
timeFrame: 01.01.2019-31.12.2019
measure: Roland Disability Questionnaire
timeFrame: 01.01.2019-31.12.2019
measure: Tampa Scale of Kinesiophobia
timeFrame: 01.01.2019-31.12.2019
measure: Visual Analogue Scale (VAS)
timeFrame: 01.01.2019-31.12.2019
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 01.01.2019-31.12.2019
measure: Oxford Hip Score
timeFrame: 01.01.2019-31.12.2019
measure: Oswestry Disability Index
timeFrame: 01.01.2019-31.12.2019
measure: Örebro Musculoskeletal Pain Screening Questionnaire
timeFrame: 01.01.2019-31.12.2019
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland MC
state: Limburg
Study officials:
affiliation: Zuyderland Medisch Centrum
name: Anouk Smeets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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