Baseline-characteristics of Patients Referred to a Secondary Spine Centre

Completed

• Conditions: Spine Disease; Spinal Disease; Demography; Characteristics Disease

• Registration Number: NCT04877470
• Lead Sponsor: Zuyderland Medisch Centrum

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.

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 Timeline

• Study Start: 2021-02-24
• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-07
• Primary Completion: 2023-03-01
• Study Completion: 2023-05-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4855

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Smoking (current status)	01.01.2019-31.12.2019	Yes/no
Duration of symptoms	01.01.2019-31.12.2019	Time since onset of symptoms in months.
Diagnosis	01.01.2019-31.12.2019	Final diagnosis as mention in the patient file, e.g. lytic spondylolisthesis, herniated disc etc.
Age	01.01.2019-31.12.2019	Age in years.
Use of pain medication	01.01.2019-31.12.2019	Paracetamol, NSAID, opioid, neuropathic pain medication
Gender	01.01.2019-31.12.2019	Male, female, other
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.
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.
Number of consultations	01.01.2019-31.12.2019	Number of consultations at the spine-centre since referral.
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.
Follow-up period	01.01.2019-31.12.2019	Time between the first consultation and the last follow-up consultations, in months.
Body Mass Index (BMI)	01.01.2019-31.12.2019	BMI = kg/m2
Type of complaints	01.01.2019-31.12.2019	Back pain, leg pain, arm pain or neck pain

Secondary Outcome Measures

Name	Time	Method
Tampa Scale of Kinesiophobia	01.01.2019-31.12.2019	Score: 17-68. 17 means no kinesiophobia, 68 means severe kinesiophobia
Örebro Musculoskeletal Pain Screening Questionnaire	01.01.2019-31.12.2019	Score: 0-210. A higher score indicated more complaints and more disability.
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.
Roland Disability Questionnaire	01.01.2019-31.12.2019	Score: 0-24. A higher score indicated more disability.
Western Ontario and McMaster Universities Osteoarthritis Index	01.01.2019-31.12.2019	Score: 0-96. A higher score indicates more complaints and disability.
Oswestry Disability Index	01.01.2019-31.12.2019	Score: 0-100 . A higher scores indicated more disability.
Visual Analogue Scale (VAS)	01.01.2019-31.12.2019	Score: 0-10. 0 is no pain, 10 is maximum pain
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.

Trial Locations

Locations (1)

Zuyderland MC; 🇳🇱 Heerlen, Limburg, Netherlands