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临床试验/NCT04877470
NCT04877470已完成不适用

Baseline-characteristics of Patients Referred to a Secondary Spine Centre

Zuyderland Medisch Centrum1 个研究点 分布在 1 个国家目标入组 4,855 人开始时间: 2021年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,855
试验地点
1
主要终点
Body Mass Index (BMI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly referred patients visiting the spine-centre at Zuyderland Medical Centre Heerlen in 2019, from 01.01.2019 until 31.12.
  • Minimum age of 18 years.
  • Documented treatment (surgical or conservative).

排除标准

  • Documented objection to participate in scientific research.
  • No baseline questionnaires available

结局指标

主要结局

Body Mass Index (BMI)

时间窗: 01.01.2019-31.12.2019

BMI = kg/m2

Smoking (current status)

时间窗: 01.01.2019-31.12.2019

Yes/no

Duration of symptoms

时间窗: 01.01.2019-31.12.2019

Time since onset of symptoms in months.

Diagnosis

时间窗: 01.01.2019-31.12.2019

Final diagnosis as mention in the patient file, e.g. lytic spondylolisthesis, herniated disc etc.

Age

时间窗: 01.01.2019-31.12.2019

Age in years.

Use of pain medication

时间窗: 01.01.2019-31.12.2019

Paracetamol, NSAID, opioid, neuropathic pain medication

Gender

时间窗: 01.01.2019-31.12.2019

Male, female, other

Type of complaints

时间窗: 01.01.2019-31.12.2019

Back pain, leg pain, arm pain or neck pain

History of spinal surgery

时间窗: 01.01.2019-31.12.2019

Spinal surgeries in the past, as mentioned in the patient file, e.g. lumbar interbody fusion, discectomy, etc.

Diagnostics tests carried out

时间窗: 01.01.2019-31.12.2019

Diagnostics as mentioned in the patient file, e.g. MRI, CT-scan, X-ray, EMG, etc.

Number of consultations

时间窗: 01.01.2019-31.12.2019

Number of consultations at the spine-centre since referral.

Reason for referral

时间窗: 01.01.2019-31.12.2019

Reason for referral, as mentioned in the general practitioner's file, e.g. persistent back pain, leg pain, etc.

Follow-up period

时间窗: 01.01.2019-31.12.2019

Time between the first consultation and the last follow-up consultations, in months.

次要结局

  • Tampa Scale of Kinesiophobia(01.01.2019-31.12.2019)
  • Örebro Musculoskeletal Pain Screening Questionnaire(01.01.2019-31.12.2019)
  • Roland Disability Questionnaire(01.01.2019-31.12.2019)
  • EuroQol 5D(01.01.2019-31.12.2019)
  • Western Ontario and McMaster Universities Osteoarthritis Index(01.01.2019-31.12.2019)
  • Oswestry Disability Index(01.01.2019-31.12.2019)
  • Visual Analogue Scale (VAS)(01.01.2019-31.12.2019)
  • Oxford Hip Score(01.01.2019-31.12.2019)

研究者

发起方
Zuyderland Medisch Centrum
申办方类型
Other
责任方
Sponsor

研究点 (1)

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