Spine DiseaseCHAPARSNCT04877470
Baseline-characteristics of Patients Referred to a Secondary Spine Centre
An observational study of Spine Disease and Characteristics Disease, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spine Disease, Characteristics Disease, Spinal Disease
- What is being tested?
- Consultation at spine-centre
- How many people
- 4,855 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Feb 2021to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult patients who are referred to the spine-centre at Zuyderland Medical Centre
Who may be able to join
- 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).
Who cannot join
- Documented objection to participate in scientific research.
- No baseline questionnaires available
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spine Disease, Characteristics Disease, Spinal Disease, Demography
- Being tested
- Consultation at spine-centre
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation at spine-centreOther
All patients who visited the spine-centre for the first time in 2019 are included in this group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Consultation at spine-centre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age in years.
Measured: 01.01.2019-31.12.2019
Gender
Male, female, other
Measured: 01.01.2019-31.12.2019
Body Mass Index (BMI)
BMI = kg/m2
Measured: 01.01.2019-31.12.2019
Smoking (current status)
Yes/no
Measured: 01.01.2019-31.12.2019
Duration of symptoms
Time since onset of symptoms in months.
Measured: 01.01.2019-31.12.2019
Type of complaints
Back pain, leg pain, arm pain or neck pain
Measured: 01.01.2019-31.12.2019
Diagnosis
Final diagnosis as mention in the patient file, e.g. lytic spondylolisthesis, herniated disc etc.
Measured: 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.
Measured: 01.01.2019-31.12.2019
Use of pain medication
Paracetamol, NSAID, opioid, neuropathic pain medication
Measured: 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.
Measured: 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.
Measured: 01.01.2019-31.12.2019
Number of consultations
Number of consultations at the spine-centre since referral.
Measured: 01.01.2019-31.12.2019
Follow-up period
Time between the first consultation and the last follow-up consultations, in months.
Measured: 01.01.2019-31.12.2019
Secondary outcomes (8)
EuroQol 5D
Score per item, total score is based on Value Sets. A lower score indicated a better quality of life.
Measured: 01.01.2019-31.12.2019
Roland Disability Questionnaire
Score: 0-24. A higher score indicated more disability.
Measured: 01.01.2019-31.12.2019
Tampa Scale of Kinesiophobia
Score: 17-68. 17 means no kinesiophobia, 68 means severe kinesiophobia
Measured: 01.01.2019-31.12.2019
Visual Analogue Scale (VAS)
Score: 0-10. 0 is no pain, 10 is maximum pain
Measured: 01.01.2019-31.12.2019
Western Ontario and McMaster Universities Osteoarthritis Index
Score: 0-96. A higher score indicates more complaints and disability.
Measured: 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.
Measured: 01.01.2019-31.12.2019
Oswestry Disability Index
Score: 0-100 . A higher scores indicated more disability.
Measured: 01.01.2019-31.12.2019
Örebro Musculoskeletal Pain Screening Questionnaire
Score: 0-210. A higher score indicated more complaints and more disability.
Measured: 01.01.2019-31.12.2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start24 Feb 2021
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,855 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anouk Smeets, MD, PhD, Principal investigator, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877470
- Sponsor's protocol ID
- Z2021026
- Acronym
- CHAPARS
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2021
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24665116Hoy 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.
PubMed 22231424Deis 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.
PubMed 21059549Deyo 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.
PubMed 19124635Saifi 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.
PubMed 30984499de 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.
PubMed 29280929Martin 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.
PubMed 18270354Weiner 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.
PubMed 16634727
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline-characteristics of Patients Referred to a Secondary Spine Centre
- ClinicalTrials.gov ID
- NCT04877470
- Acronym / sponsor ID
- CHAPARS / Z2021026
- Conditions
- Spine Disease, Characteristics Disease, Spinal Disease, Demography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,855 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly referred patients visiting the spine-centre | – | Other: Consultation at spine-centreNewly referred patients visiting the spine-centre at Zuyderland Medical Centre Heerlen in 2019, from 01.01.2019 until 31.12.2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients who are referred to the spine-centre at Zuyderland Medical Centre
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Documented objection to participate in scientific research.
- No baseline questionnaires available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consultation at spine-centreAll patients who visited the spine-centre for the first time in 2019 are included in this group. | Other | Newly referred patients visiting the spine-centre |
Primary outcome
Age
Time frame: 01.01.2019-31.12.2019
Age in years.
Gender
Time frame: 01.01.2019-31.12.2019
Male, female, other
Body Mass Index (BMI)
Time frame: 01.01.2019-31.12.2019
BMI = kg/m2
Smoking (current status)
Time frame: 01.01.2019-31.12.2019
Yes/no
Duration of symptoms
Time frame: 01.01.2019-31.12.2019
Time since onset of symptoms in months.
Type of complaints
Time frame: 01.01.2019-31.12.2019
Back pain, leg pain, arm pain or neck pain
Diagnosis
Time frame: 01.01.2019-31.12.2019
Final diagnosis as mention in the patient file, e.g. lytic spondylolisthesis, herniated disc etc.
History of spinal surgery
Time frame: 01.01.2019-31.12.2019
Spinal surgeries in the past, as mentioned in the patient file, e.g. lumbar interbody fusion, discectomy, etc.
Use of pain medication
Time frame: 01.01.2019-31.12.2019
Paracetamol, NSAID, opioid, neuropathic pain medication
Reason for referral
Time frame: 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.
Diagnostics tests carried out
Time frame: 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
Time frame: 01.01.2019-31.12.2019
Number of consultations at the spine-centre since referral.
Follow-up period
Time frame: 01.01.2019-31.12.2019
Time between the first consultation and the last follow-up consultations, in months.
8 secondary outcomes
EuroQol 5D
Time frame: 01.01.2019-31.12.2019
Roland Disability Questionnaire
Time frame: 01.01.2019-31.12.2019
Tampa Scale of Kinesiophobia
Time frame: 01.01.2019-31.12.2019
Visual Analogue Scale (VAS)
Time frame: 01.01.2019-31.12.2019
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 01.01.2019-31.12.2019
Oxford Hip Score
Time frame: 01.01.2019-31.12.2019
Oswestry Disability Index
Time frame: 01.01.2019-31.12.2019
Örebro Musculoskeletal Pain Screening Questionnaire
Time frame: 01.01.2019-31.12.2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 24665116Hoy 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.
- Background: PubMed 22231424Hoy 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.
- Background: PubMed 21059549Deis 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.
- Background: PubMed 19124635Deyo 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.
- Background: PubMed 30984499Saifi 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.
- Background: PubMed 29280929de 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.
- Background: PubMed 18270354Martin 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.
- Background: PubMed 16634727Weiner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anouk Smeets, MD, PhD principal investigator
Zuyderland Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Disease and Characteristics Disease, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: 01.01.2019-31.12.2019). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877470, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.