Lumbar Disc HerniationSpine PROMCONCT05963815
The Spine PROMCO Study
An observational study of Lumbar Disc Herniation and Spondylolisthesis, run by Park Medical centrum at 1 site in Netherlands.
Trial summary
Our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Disc Herniation, Spondylolisthesis, Spinal Stenosis
- What is being tested?
- Spine surgery
- How many people
- 4,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jan 2023to 13 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.
Who may be able to join
- All patients who are eligible for elective surgery of the lumbar spine.
- All patients with degenerative disorder of the lumbar spine including: herniated disk, stenosis, discopathy and spondylolisthesis.
- Patients must be able to fill in the questionnaire online
- Patients with imaging (Magnetic resonance imaging (MRI)) confirmed lumbar disc herniation, stenosis, discopathy, or listhesis.
- Elective cases
- Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.
Who cannot join
- Patients who cannot speak nor read the Dutch language
- Patients who are not able to complete the digital questionnaires, according to the including doctor
- Patients with fractures, primary infections of the spine, or with spinal malignant- cies.
- Patients in a traumatic setting.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Park Medical Center
Rotterdam, South Holland, 30677 GH
Annegien Boeykens, MD, 010 436 1537, a.boeykens@parkmc.nl
B.Sanjay Harhangi, MD, PhD
About this study
Official title: Spine Patient Reported Outcome Measures: a Cohort Observational Study
Our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program.
Read the detailed description
This observational prospective unicenter cohort study includes patients who are eligible for elective lumbar spine surgery due to a degenerative spine disease (e.g. herniated disk, spinal canal stenosis, discopathy and spondylolisthesis). An enrolment rate of at least 80% is pursued within minimal 1.5 years of inclusion. A digital survey is used including self-reporting questionnaires that pertain to outcomes as pain, functionality and disability (COMI Back), health status (EQ-5D-5L), re-operations and complications, and satisfaction. The survey is sent at given time-intervals (e.g. baseline 2 weeks prior to surgery, 6 weeks post surgery and 6, 12, 36 months post surgery). Besides descriptive statistics and multivariate analysis, an economic evaluation will be performed from a societal perspective.
- Conditions
- Lumbar Disc Herniation, Spondylolisthesis, Spinal Stenosis
- Being tested
- Spine surgery
- Keywords
- Patient related outcome measures, Prognosis, Degenerative Spine disease
- Medical subject headings
- Intervertebral Disc Displacement, Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine surgeryOther
Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.
| Study group | Role | What they receive |
|---|---|---|
| Degenerative spine disorder | Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis. Receives: Other: Spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and functionality - COMI BACK
The Core Outcome Measures Index (COMI) Back index score (range 0-10) is calculated by averaging transformed core-item scores from each domain of the five domains: pain symptoms (including NRS-scale), functionality of back, symptom-specific well-being, general well-being, and disability. Although the Oswestry disability index (ODI) is the most commonly used and cited tool, the COMI Back was chosen instead to assess pain intensity, functionality and disability within the study group. The COMI back is relatively short (7 questions), includes the NRS-scale (painscore from 0 (no pain) - 10 (worst possible pain), and has been cross-culturally adapted and validated in several languages, including in Dutch. It is the preferred tool of the Eurospine Registry.
Measured: Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
Health status - EQ5DL
The eq-5D-5L (Euroquality 5 domains 5 level) health questionnaire provides a simple descriptive profile and a single index value for health status. The EQ-VAS is part of the EQ-5D-5L and it is a visual scale in which the patient can indicate the perception of their health status at the time of assessment, with 100 being perfect health status and 0 the worst health status. With the EQ-5D-5L we can assess the quality-adjusted life years (QALY).
Measured: Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
Secondary outcomes (3)
Number of Re-operations
Re-operation due to a complication or recidive is self-reported and registered in the Electronic medical record.
Measured: post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
Complication
Complications are systematically assessed by self-reported questionnaires (e.g. Cerebro spinal fluid leakage, sensomotoric deficits, incontinence, infections, etc).
Measured: post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
Satisfaction
Patient's satisfaction will be assessed using a 5-point Likert Scale to touch on the subject of: (1) hospital satisfaction, (2) treatment satisfaction, (3) recovery satisfaction and (4) response burden of the study. With 1 being very dissatisfied and 5 very satisfied.
Measured: 6 weeks, 6-12-36 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start13 Jan 2023
- Primary completion13 Jan 2030 (estimated)
- Study completion13 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Park Medical centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963815
- Sponsor's protocol ID
- 0000090
- Acronym
- Spine PROMCO
- Status last verified
- Sep 2023
- First submitted
- 19 Jul 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870Hoy 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 24665116Parenteau CS, Lau EC, Campbell IC, Courtney A. Prevalence of spine degeneration diagnosis by type, age, gender, and obesity using Medicare data. Sci Rep. 2021 Mar 8;11(1):5389. doi: 10.1038/s41598-021-84724-6.
PubMed 33686128Konstantinou K, Dunn KM. Sciatica: review of epidemiological studies and prevalence estimates. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2464-72. doi: 10.1097/BRS.0b013e318183a4a2.
PubMed 18923325Grotle M, Smastuen MC, Fjeld O, Grovle L, Helgeland J, Storheim K, Solberg TK, Zwart JA. Lumbar spine surgery across 15 years: trends, complications and reoperations in a longitudinal observational study from Norway. BMJ Open. 2019 Aug 1;9(8):e028743. doi: 10.1136/bmjopen-2018-028743.
PubMed 31375617Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.
PubMed 26571179Asher AL, Knightly J, Mummaneni PV, Alvi MA, McGirt MJ, Yolcu YU, Chan AK, Glassman SD, Foley KT, Slotkin JR, Potts EA, Shaffrey ME, Shaffrey CI, Haid RW, Fu KM, Wang MY, Park P, Bisson EF, Harbaugh RE, Bydon M. Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry. Neurosurg Focus. 2020 May 1;48(5):E2. doi: 10.3171/2020.2.FOCUS207.
PubMed 32357320van Hooff ML, Jacobs WC, Willems PC, Wouters MW, de Kleuver M, Peul WC, Ostelo RW, Fritzell P. Evidence and practice in spine registries. Acta Orthop. 2015;86(5):534-44. doi: 10.3109/17453674.2015.1043174.
PubMed 25909475Gadjradj PS, Chin-See-Chong TC, Donk D, Depauw P, Tulder MWV, Harhangi BS. Cross-Cultural Adaptation and Psychometric Validation of the Dutch Version of the Core Outcome Measures Index for the Neck in Patients Undergoing Surgery for Degenerative Disease of the Cervical Spine. Neurospine. 2021 Dec;18(4):798-805. doi: 10.14245/ns.2142682.341. Epub 2021 Dec 31.
PubMed 35000334Mannion AF, Vila-Casademunt A, Domingo-Sabat M, Wunderlin S, Pellise F, Bago J, Acaroglu E, Alanay A, Perez-Grueso FS, Obeid I, Kleinstuck FS; European Spine Study Group (ESSG). The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity. Eur Spine J. 2016 Aug;25(8):2638-48. doi: 10.1007/s00586-015-4292-4. Epub 2015 Oct 30.
PubMed 26519374Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.
PubMed 28194657
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Patient Reported Outcome Measures: a Cohort Observational Study
- ClinicalTrials.gov ID
- NCT05963815
- Acronym / sponsor ID
- Spine PROMCO / 0000090
- Conditions
- Lumbar Disc Herniation, Spondylolisthesis, Spinal Stenosis
- Keywords
- Patient related outcome measures, Prognosis, Degenerative Spine disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Park Medical centrumUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 13 Jan 2030 (estimated)
- Study completion
- 13 Jan 2030 (estimated)
- First posted
- 27 Jul 2023 (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.
Our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program.
Detailed description
This observational prospective unicenter cohort study includes patients who are eligible for elective lumbar spine surgery due to a degenerative spine disease (e.g. herniated disk, spinal canal stenosis, discopathy and spondylolisthesis). An enrolment rate of at least 80% is pursued within minimal 1.5 years of inclusion. A digital survey is used including self-reporting questionnaires that pertain to outcomes as pain, functionality and disability (COMI Back), health status (EQ-5D-5L), re-operations and complications, and satisfaction. The survey is sent at given time-intervals (e.g. baseline 2 weeks prior to surgery, 6 weeks post surgery and 6, 12, 36 months post surgery). Besides descriptive statistics and multivariate analysis, an economic evaluation will be performed from a societal perspective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degenerative spine disorder | – | Other: Spine surgeryPatients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.
Key inclusion criteria (6 listed)
- All patients who are eligible for elective surgery of the lumbar spine.
- All patients with degenerative disorder of the lumbar spine including: herniated disk, stenosis, discopathy and spondylolisthesis.
- Patients must be able to fill in the questionnaire online
- Patients with imaging (Magnetic resonance imaging (MRI)) confirmed lumbar disc herniation, stenosis, discopathy, or listhesis.
- Elective cases
Key exclusion criteria (4 listed)
- Patients who cannot speak nor read the Dutch language
- Patients who are not able to complete the digital questionnaires, according to the including doctor
- Patients with fractures, primary infections of the spine, or with spinal malignant- cies.
- Patients in a traumatic setting.
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 |
|---|---|---|
| Spine surgeryPatients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis. | Other | Degenerative spine disorder |
Primary outcome
Pain and functionality - COMI BACK
Time frame: Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
The Core Outcome Measures Index (COMI) Back index score (range 0-10) is calculated by averaging transformed core-item scores from each domain of the five domains: pain symptoms (including NRS-scale), functionality of back, symptom-specific well-being, general well-being, and disability. Although the Oswestry disability index (ODI) is the most commonly used and cited tool, the COMI Back was chosen instead to assess pain intensity, functionality and disability within the study group. The COMI back is relatively short (7 questions), includes the NRS-scale (painscore from 0 (no pain) - 10 (worst possible pain), and has been cross-culturally adapted and validated in several languages, including in Dutch. It is the preferred tool of the Eurospine Registry.
Health status - EQ5DL
Time frame: Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
The eq-5D-5L (Euroquality 5 domains 5 level) health questionnaire provides a simple descriptive profile and a single index value for health status. The EQ-VAS is part of the EQ-5D-5L and it is a visual scale in which the patient can indicate the perception of their health status at the time of assessment, with 100 being perfect health status and 0 the worst health status. With the EQ-5D-5L we can assess the quality-adjusted life years (QALY).
3 secondary outcomes
Number of Re-operations
Time frame: post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
Complication
Time frame: post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
Satisfaction
Time frame: 6 weeks, 6-12-36 months post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 29573870Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
- 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 33686128Parenteau CS, Lau EC, Campbell IC, Courtney A. Prevalence of spine degeneration diagnosis by type, age, gender, and obesity using Medicare data. Sci Rep. 2021 Mar 8;11(1):5389. doi: 10.1038/s41598-021-84724-6.
- Background: PubMed 18923325Konstantinou K, Dunn KM. Sciatica: review of epidemiological studies and prevalence estimates. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2464-72. doi: 10.1097/BRS.0b013e318183a4a2.
- Background: PubMed 31375617Grotle M, Smastuen MC, Fjeld O, Grovle L, Helgeland J, Storheim K, Solberg TK, Zwart JA. Lumbar spine surgery across 15 years: trends, complications and reoperations in a longitudinal observational study from Norway. BMJ Open. 2019 Aug 1;9(8):e028743. doi: 10.1136/bmjopen-2018-028743.
- Background: PubMed 26571179Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.
- Background: PubMed 32357320Asher AL, Knightly J, Mummaneni PV, Alvi MA, McGirt MJ, Yolcu YU, Chan AK, Glassman SD, Foley KT, Slotkin JR, Potts EA, Shaffrey ME, Shaffrey CI, Haid RW, Fu KM, Wang MY, Park P, Bisson EF, Harbaugh RE, Bydon M. Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry. Neurosurg Focus. 2020 May 1;48(5):E2. doi: 10.3171/2020.2.FOCUS207.
- Background: PubMed 25909475van Hooff ML, Jacobs WC, Willems PC, Wouters MW, de Kleuver M, Peul WC, Ostelo RW, Fritzell P. Evidence and practice in spine registries. Acta Orthop. 2015;86(5):534-44. doi: 10.3109/17453674.2015.1043174.
- Background: PubMed 35000334Gadjradj PS, Chin-See-Chong TC, Donk D, Depauw P, Tulder MWV, Harhangi BS. Cross-Cultural Adaptation and Psychometric Validation of the Dutch Version of the Core Outcome Measures Index for the Neck in Patients Undergoing Surgery for Degenerative Disease of the Cervical Spine. Neurospine. 2021 Dec;18(4):798-805. doi: 10.14245/ns.2142682.341. Epub 2021 Dec 31.
- Background: PubMed 26519374Mannion AF, Vila-Casademunt A, Domingo-Sabat M, Wunderlin S, Pellise F, Bago J, Acaroglu E, Alanay A, Perez-Grueso FS, Obeid I, Kleinstuck FS; European Spine Study Group (ESSG). The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity. Eur Spine J. 2016 Aug;25(8):2638-48. doi: 10.1007/s00586-015-4292-4. Epub 2015 Oct 30.
- Background: PubMed 28194657Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.
- 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.
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 Lumbar Disc Herniation and Spondylolisthesis, run by Park Medical 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Sep 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annegien Boeykens, MD (010 436 1537, a.boeykens@parkmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and functionality - COMI BACK (time frame: Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery). The study lists 2 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 NCT05963815, which also lists 11 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 28 Sep 2023.