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

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.

Study Overview

• Status: Completed
• Conditions: Spine Disease; Spinal Disease; Characteristics Disease; Demography
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 4855

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419PC
      • Zuyderland MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: JAMA. 2008 Jun 11;299(22):2630.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: Z2021026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No