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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04877470
Other study ID # Z2021026
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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