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Completed

NCT Number: NCT04877470

Baseline-characteristics of Patients Referred to a Secondary Spine Centre

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuyderland MC

Heerlen, Limburg, 6419PC, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consultation at spine-centre

Other

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

Primary outcomes

  1. Age

    Time frame: 01.01.2019-31.12.2019

    Age in years.

  2. Gender

    Time frame: 01.01.2019-31.12.2019

    Male, female, other

  3. Body Mass Index (BMI)

    Time frame: 01.01.2019-31.12.2019

    BMI = kg/m2

  4. Smoking (current status)

    Time frame: 01.01.2019-31.12.2019

    Yes/no

  5. Duration of symptoms

    Time frame: 01.01.2019-31.12.2019

    Time since onset of symptoms in months.

  6. Type of complaints

    Time frame: 01.01.2019-31.12.2019

    Back pain, leg pain, arm pain or neck pain

  7. Diagnosis

    Time frame: 01.01.2019-31.12.2019

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

  8. History of spinal surgery

    Time frame: 01.01.2019-31.12.2019

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

  9. Use of pain medication

    Time frame: 01.01.2019-31.12.2019

    Paracetamol, NSAID, opioid, neuropathic pain medication

  10. Reason for referral

    Time frame: 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.

  11. Diagnostics tests carried out

    Time frame: 01.01.2019-31.12.2019

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

  12. Number of consultations

    Time frame: 01.01.2019-31.12.2019

    Number of consultations at the spine-centre since referral.

  13. Follow-up period

    Time frame: 01.01.2019-31.12.2019

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

Secondary outcomes

  1. EuroQol 5D

    Time frame: 01.01.2019-31.12.2019

    Score per item, total score is based on Value Sets. A lower score indicated a better quality of life.

  2. Roland Disability Questionnaire

    Time frame: 01.01.2019-31.12.2019

    Score: 0-24. A higher score indicated more disability.

  3. Tampa Scale of Kinesiophobia

    Time frame: 01.01.2019-31.12.2019

    Score: 17-68. 17 means no kinesiophobia, 68 means severe kinesiophobia

  4. Visual Analogue Scale (VAS)

    Time frame: 01.01.2019-31.12.2019

    Score: 0-10. 0 is no pain, 10 is maximum pain

  5. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: 01.01.2019-31.12.2019

    Score: 0-96. A higher score indicates more complaints and disability.

  6. Oxford Hip Score

    Time frame: 01.01.2019-31.12.2019

    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.

  7. Oswestry Disability Index

    Time frame: 01.01.2019-31.12.2019

    Score: 0-100 . A higher scores indicated more disability.

  8. Örebro Musculoskeletal Pain Screening Questionnaire

    Time frame: 01.01.2019-31.12.2019

    Score: 0-210. A higher score indicated more complaints and more disability.

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Registry information

Acronym: CHAPARS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 7, 2021
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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