Baseline-characteristics of Patients Referred to a Secondary Spine Centre

Spinal Disease Clinical Trial

— CHAPARS  

Official title:

Baseline-characteristics of Patients Referred to a Secondary Spine Centre

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877470
• Other study ID #: Z2021026
• Status: Completed
• Start date: February 24, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2024
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4855
• Est. completion date: May 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Characteristics Disease
• Demography
• Spinal Disease
• Spinal Diseases
• Spine Disease

Intervention

Other:
• Consultation at spine-centre
All patients who visited the spine-centre for the first time in 2019 are included in this group.

Locations

Country	Name	City	State
Netherlands	Zuyderland MC	Heerlen	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Age in years.	01.01.2019-31.12.2019
Primary	Gender	Male, female, other	01.01.2019-31.12.2019
Primary	Body Mass Index (BMI)	BMI = kg/m2	01.01.2019-31.12.2019
Primary	Smoking (current status)	Yes/no	01.01.2019-31.12.2019
Primary	Duration of symptoms	Time since onset of symptoms in months.	01.01.2019-31.12.2019
Primary	Type of complaints	Back pain, leg pain, arm pain or neck pain	01.01.2019-31.12.2019
Primary	Diagnosis	Final diagnosis as mention in the patient file, e.g. lytic spondylolisthesis, herniated disc etc.	01.01.2019-31.12.2019
Primary	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
Primary	Use of pain medication	Paracetamol, NSAID, opioid, neuropathic pain medication	01.01.2019-31.12.2019
Primary	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
Primary	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
Primary	Number of consultations	Number of consultations at the spine-centre since referral.	01.01.2019-31.12.2019
Primary	Follow-up period	Time between the first consultation and the last follow-up consultations, in months.	01.01.2019-31.12.2019
Secondary	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
Secondary	Roland Disability Questionnaire	Score: 0-24. A higher score indicated more disability.	01.01.2019-31.12.2019
Secondary	Tampa Scale of Kinesiophobia	Score: 17-68. 17 means no kinesiophobia, 68 means severe kinesiophobia	01.01.2019-31.12.2019
Secondary	Visual Analogue Scale (VAS)	Score: 0-10. 0 is no pain, 10 is maximum pain	01.01.2019-31.12.2019
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index	Score: 0-96. A higher score indicates more complaints and disability.	01.01.2019-31.12.2019
Secondary	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
Secondary	Oswestry Disability Index	Score: 0-100 . A higher scores indicated more disability.	01.01.2019-31.12.2019
Secondary	Örebro Musculoskeletal Pain Screening Questionnaire	Score: 0-210. A higher score indicated more complaints and more disability.	01.01.2019-31.12.2019