CHAPARS: Baseline-characteristics of Patients Referred to a Secondary Spine Centre

Sponsor
Zuyderland Medisch Centrum (Other)
Overall Status
Recruiting
CT.gov ID
NCT04877470
Collaborator
(none)
3,000
1
26.2
114.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Consultation at 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Baseline-characteristics of Patients Referred to a Secondary Spine Centre
Actual Study Start Date :
Feb 24, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Newly referred patients visiting the spine-centre

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.

Outcome Measures

Primary Outcome Measures

  1. Age [01.01.2019-31.12.2019]

    Age in years.

  2. Gender [01.01.2019-31.12.2019]

    Male, female, other

  3. Body Mass Index (BMI) [01.01.2019-31.12.2019]

    BMI = kg/m2

  4. Smoking (current status) [01.01.2019-31.12.2019]

    Yes/no

  5. Duration of symptoms [01.01.2019-31.12.2019]

    Time since onset of symptoms in months.

  6. Type of complaints [01.01.2019-31.12.2019]

    Back pain, leg pain, arm pain or neck pain

  7. Diagnosis [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 [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 [01.01.2019-31.12.2019]

    Paracetamol, NSAID, opioid, neuropathic pain medication

  10. Reason for referral [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 [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 [01.01.2019-31.12.2019]

    Number of consultations at the spine-centre since referral.

  13. Follow-up period [01.01.2019-31.12.2019]

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

Secondary Outcome Measures

  1. EuroQol 5D [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 [01.01.2019-31.12.2019]

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

  3. Tampa Scale of Kinesiophobia [01.01.2019-31.12.2019]

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

  4. Visual Analogue Scale (VAS) [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 [01.01.2019-31.12.2019]

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

  6. Oxford Hip Score [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 [01.01.2019-31.12.2019]

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

  8. Örebro Musculoskeletal Pain Screening Questionnaire [01.01.2019-31.12.2019]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zuyderland MC Heerlen Limburg Netherlands 6419PC

Sponsors and Collaborators

  • Zuyderland Medisch Centrum

Investigators

  • Principal Investigator: Anouk Smeets, MD, PhD, Zuyderland Medisch Centrum

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier:
NCT04877470
Other Study ID Numbers:
  • Z2021026
First Posted:
May 7, 2021
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2022