NCT04877470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,855

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

April 22, 2021

Last Update Submit

February 1, 2024

Conditions

Spine DiseaseCharacteristics DiseaseSpinal DiseaseDemography

Outcome Measures

Primary Outcomes (13)

  • Age

    Age in years.

    01.01.2019-31.12.2019

  • Gender

    Male, female, other

    01.01.2019-31.12.2019

  • Body Mass Index (BMI)

    BMI = kg/m2

    01.01.2019-31.12.2019

  • Smoking (current status)

    Yes/no

    01.01.2019-31.12.2019

  • Duration of symptoms

    Time since onset of symptoms in months.

    01.01.2019-31.12.2019

  • Type of complaints

    Back pain, leg pain, arm pain or neck pain

    01.01.2019-31.12.2019

  • Diagnosis

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

    01.01.2019-31.12.2019

  • History of spinal surgery

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

    01.01.2019-31.12.2019

  • Use of pain medication

    Paracetamol, NSAID, opioid, neuropathic pain medication

    01.01.2019-31.12.2019

  • Reason for referral

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

    01.01.2019-31.12.2019

  • Diagnostics tests carried out

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

    01.01.2019-31.12.2019

  • Number of consultations

    Number of consultations at the spine-centre since referral.

    01.01.2019-31.12.2019

  • Follow-up period

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

    01.01.2019-31.12.2019

Secondary Outcomes (8)

  • EuroQol 5D

    01.01.2019-31.12.2019

  • Roland Disability Questionnaire

    01.01.2019-31.12.2019

  • Tampa Scale of Kinesiophobia

    01.01.2019-31.12.2019

  • Visual Analogue Scale (VAS)

    01.01.2019-31.12.2019

  • Western Ontario and McMaster Universities Osteoarthritis Index

    01.01.2019-31.12.2019

  • +3 more secondary outcomes

Study Arms (1)

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

Interventions

Consultation at spine-centreOTHER

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

Newly referred patients visiting the spine-centre

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of adult patients who are referred to the spine-centre at Zuyderland Medical Centre

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuyderland MC

Heerlen, Limburg, 6419PC, Netherlands

Location

Related Publications (8)

  • Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

    PMID: 24665116BACKGROUND

  • Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

    PMID: 22231424BACKGROUND

  • Deis N, Findlay JM. Appropriateness of lumbar spine referrals to a neurosurgical service. Can J Neurol Sci. 2010 Nov;37(6):843-8. doi: 10.1017/s0317167100051544.

    PMID: 21059549BACKGROUND

  • Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102.

    PMID: 19124635BACKGROUND

  • Saifi C, Cazzulino A, Laratta J, Save AV, Shillingford JN, Louie PK, Pugely AJ, Arlet V. Utilization and Economic Impact of Posterolateral Fusion and Posterior/Transforaminal Lumbar Interbody Fusion Surgeries in the United States. Global Spine J. 2019 Apr;9(2):185-190. doi: 10.1177/2192568218790557. Epub 2018 Aug 15.

    PMID: 30984499BACKGROUND

  • de Kunder SL, Rijkers K, Caelers IJMH, de Bie RA, Koehler PJ, van Santbrink H. Lumbar Interbody Fusion: A Historical Overview and a Future Perspective. Spine (Phila Pa 1976). 2018 Aug;43(16):1161-1168. doi: 10.1097/BRS.0000000000002534.

    PMID: 29280929BACKGROUND

  • Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. doi: 10.1001/jama.299.6.656.

    PMID: 18270354BACKGROUND

  • Weiner DK, Kim YS, Bonino P, Wang T. Low back pain in older adults: are we utilizing healthcare resources wisely? Pain Med. 2006 Mar-Apr;7(2):143-50. doi: 10.1111/j.1526-4637.2006.00112.x.

    PMID: 16634727BACKGROUND

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Anouk Smeets, MD, PhD

    Zuyderland Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

May 7, 2021

Study Start

February 24, 2021

Primary Completion

March 1, 2023

Study Completion

May 1, 2023

Last Updated

February 2, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)