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Baseline-characteristics of Patients Referred to a Secondary Spine Centre

Baseline-characteristics of Patients Referred to a Secondary Spine Centre

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04877470
Acronym
CHAPARS
Enrollment
4855
Registered
2021-05-07
Start date
2021-02-24
Completion date
2023-05-01
Last updated
2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Characteristics Disease, Demography, Spinal Disease, Spine Disease

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.

Interventions

OTHERConsultation at spine-centre

All patients who visited the spine-centre for the first time in 2019 are included in this group.

Sponsors

Zuyderland Medisch Centrum
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Follow-up period01.01.2019-31.12.2019Time between the first consultation and the last follow-up consultations, in months.
Duration of symptoms01.01.2019-31.12.2019Time since onset of symptoms in months.
Type of complaints01.01.2019-31.12.2019Back pain, leg pain, arm pain or neck pain
Diagnosis01.01.2019-31.12.2019Final diagnosis as mention in the patient file, e.g. lytic spondylolisthesis, herniated disc etc.
History of spinal surgery01.01.2019-31.12.2019Spinal surgeries in the past, as mentioned in the patient file, e.g. lumbar interbody fusion, discectomy, etc.
Use of pain medication01.01.2019-31.12.2019Paracetamol, NSAID, opioid, neuropathic pain medication
Reason for referral01.01.2019-31.12.2019Reason for referral, as mentioned in the general practitioner's file, e.g. persistent back pain, leg pain, etc.
Diagnostics tests carried out01.01.2019-31.12.2019Diagnostics as mentioned in the patient file, e.g. MRI, CT-scan, X-ray, EMG, etc.
Number of consultations01.01.2019-31.12.2019Number of consultations at the spine-centre since referral.
Age01.01.2019-31.12.2019Age in years.
Gender01.01.2019-31.12.2019Male, female, other
Body Mass Index (BMI)01.01.2019-31.12.2019BMI = kg/m2
Smoking (current status)01.01.2019-31.12.2019Yes/no

Secondary

MeasureTime frameDescription
Roland Disability Questionnaire01.01.2019-31.12.2019Score: 0-24. A higher score indicated more disability.
Tampa Scale of Kinesiophobia01.01.2019-31.12.2019Score: 17-68. 17 means no kinesiophobia, 68 means severe kinesiophobia
Visual Analogue Scale (VAS)01.01.2019-31.12.2019Score: 0-10. 0 is no pain, 10 is maximum pain
Western Ontario and McMaster Universities Osteoarthritis Index01.01.2019-31.12.2019Score: 0-96. A higher score indicates more complaints and disability.
Oxford Hip Score01.01.2019-31.12.2019Score: 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.
Oswestry Disability Index01.01.2019-31.12.2019Score: 0-100 . A higher scores indicated more disability.
Örebro Musculoskeletal Pain Screening Questionnaire01.01.2019-31.12.2019Score: 0-210. A higher score indicated more complaints and more disability.
EuroQol 5D01.01.2019-31.12.2019Score per item, total score is based on Value Sets. A lower score indicated a better quality of life.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026