Back PainNCT06402409
Exploring Multimorbidity in Patients With Spinal Pain
An observational study of Back Pain and Neck Pain, run by Jacob Christiansen Gandløse at 1 site in Denmark.
Trial summary
Spinal pain is frequently accompanied by other chronic conditions (multimorbidity) and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Neck Pain, Comorbidities and Coexisting Conditions
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2024to 1 Oct 2026
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred with spinal pain to Aalborg University Hospital's Department of Rheumatology or the Medical Spine Clinic in Silkeborg during the recruitment time.
Who may be able to join
- 18 years old or above
- Are diagnosed with neck or back pain
- Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)
- Speak, read and understand Danish
Who cannot join
- Withdraw consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Jacob Gandløse, PhD student, 50998483, j.gandloese@rn.dk
About this study
Official title: Workpackage 1: Baseline Prevalence and Implications of Multimorbidity for the Management of Spinal Pain Workpackage 2: The Influence of Multimorbidity Treatment Burden on Long-term Prognosis of Individuals With Spinal Pain
Spinal pain is frequently accompanied by other chronic conditions (multimorbidity) and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions.
Therefore the aims of the two studies are to:
Read more
Work package 1 - Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics. Examine associations with relevant health-related factors and cover the significance of multimorbidity in the diagnostic process, referral patterns and healthcare utilization.
Work package 2: Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation.
Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital (AaUH) or the Medical Spine Clinic in Silkeborg (MSCS).
Read the detailed description
Background:
Spinal pain is frequently accompanied by other chronic conditions (multimorbidity) and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions.
Objectives:
Work package 1: Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics. Examine associations with various health-related factors and cover the significance of multimorbidity in the diagnostic process, referral patterns and healthcare utilization.
Work package 2: Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation.
Methods:
The project consists of two work packages: A cross sectional study (Work package 1) and a prospective observational cohort study (Work package 2).
Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital (AaUH) or the Medical Spine Clinic in Silkeborg (MSCS). In work package 1 patients with scheduled appointments at the Departments are identified via the hospital's electronic booking system. Secure questionnaires are sent via E-Boks.
Data for the work packages will be collected through the hospital's electronic journal systems, patient-reported outcome measures (PROMs) and external danish registers. PROMS will be collected with REDCap at baseline and 3, 6, and 12 months after the initial consultation in the outpatient clinics. The patients' unique civil registration number (CPR) will be linked to external Danish registries facilitated by the Danish Civil Registration System (CRS).
Variables:
Electronic questionnaires: Name, CPR number, Marital status, Height and weight, Smoking and alcohol habits, and PROMS (elaborated elsewhere)
Medical records: Past and current medication use, referral source (general practitioner, specialist, hospital), Past treatment attempts (physiotherapy, chiropractic, etc.), Information on any scans performed (if any), Signs of radiculopathy, Number of consultations.
External registries:
- "The Danish Civil Registration System": Age, sex, Migration status, Vital status.
- "The Danish National Patient Registry": Concurrent diseases (ICD-10 codes), Period from referral date to treatment start date, Start and end dates of outpatient treatment.
- "The Danish National Prescription Registry": All dispensed medications from Danish pharmacies (ATC codes).
- "The Population Education Register": Highest completed level of education (short, medium, long)
- "DREAM database": Income status and public financial support.
Statistical considerations:
Work package 1: A cross-sectional study
Prevalence of multimorbidity and frequency of other diseases will be reported as percentages and total counts and presented in a table. Regression analysis will be emplyed to determine whether the number of chronic conditions or specific clusters of chronic conditions are associated with the primary outcome, EQ-5D-5L, other patient-reported measures, and use of healthcare services. Additionally, patients will be divided into groups categorized by the Multimorbidity Treatment Burden Questionnaire following the classification established by Duncan et al. These categories will divide participants into four distinct categories: no burden (score 0), low burden (score <10), medium burden (score 10-22), and high burden (score ≥22). Analysis of Covariance (ANCOVA) will be employed to determine whether there are statistically significant differences in EQ-5D-5L scores between the groups while accounting for potential confounding covariates. Individual plots will be generated to visually depict the distribution of patient scores on EQ-5D-5L and Brief Pain Inventory across the four groups.
Work package 2: An observational prospective cohort study
As in work package 1, patients will be categorized into groups based on their baseline treatment burden. Mixed model with repeated measures will be utilized to determine whether there are statistically significant differences in EQ-5D-5L scores and BPI-scores between groups over time (baseline, 3-6-12 months follow-up), while accounting for potential confounding covariates. Line graphs with error bars will be generated to visually depict the changes in EQ-5D-5L and BPI across the four groups.
For both workpackages missing data will be addressed by multiple imputation or other means if not deemed appropiate. The imputation model will be informed by existing literature and by a dropout analysis. In addition, the selection of covariates for inclusion in the statistical models will be guided by current evidence and clinical reasoning to account for potential confounding factors.
In assessing the prevalence of multimorbidity, it is defined as the presence of two concurrent chronic diseases in a single individual. To discern which ICD-10 codes correspond to chronic health conditions, a unique script has been devised. This script draws from previous studies, particularly those focused on determining multimorbidity prevalence, and incorporates recommendations from international consensus on multimorbidity measurement in research. The validation of ICD-10 codes in the Danish National Patient Registry (DNPR) and the Primary Care Referral Registry (PCRR) has been systematically conducted across various diagnoses and studies, affirming their accuracy for research purposes.
- Keywords
- Multimorbidity, Comorbidities, Comorbidity, Neck Pain, Back Pain, Spinal pain
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: No treatment burden | Individuals scoring a total of 0 points on the Multimorbidity Treatment Burden Questionnaire, reflecting no perceived treatment burden. | |
| Group 2: Low treatment burden | Individuals scoring a total of below 10 points (but over 0) on the Multimorbidity Treatment Burden Questionnaire, reflecting low perceived treatment burden. | |
| Group 3: Medium treatment burden | Individuals scoring a total of between 10 and 22 points on the Multimorbidity Treatment Burden Questionnaire, reflecting medium perceived treatment burden. | |
| Group 4: High treatment burden | Individuals scoring a total of over 22 points on the Multimorbidity Treatment Burden Questionnaire, reflecting high perceived treatment burden. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
The EQ-5D-5L questionnaire is a standardized measure of health-related quality of life recommended for multimorbidity research. The EQ-5D-5L assesses health status across five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-point ordinal scale ranging from 1 (indicating no problems) to 5 (indicating extreme difficulties) The EQ-5D index score can be regarded as a continuous outcome and ranges from -0.624 to 1, with higher scores indicating better general health and quality of life.
Measured: EQ-5D-5L will be collected at baseline, 3, 6, and 12 months of follow-up.
Secondary outcomes (1)
Brief Pain Inventory
The Brief Pain Inventory (BPI) is considered the secondary outcome variable. The questionnaire assesses pain in two dimensions: pain intensity and pain interference with function, mood, sleep, and social life, and is a recommended core outcome measure in clinical trials of chronic pain. All items are scored from 0-10, with 0 indicating no pain or interference and 10 indicating worst imaginable pain/completely interference. Hence the sum 0-40 is averaged between the four items about pain intensity, and the sum 0-70 is averaged between the seven items about pain interference.
Measured: BPI will be collected at baseline, 3, 6, and 12 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Apr 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies 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
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jacob Christiansen Gandløse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacob Christiansen Gandløse, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402409
- Sponsor's protocol ID
- F2023-169
- Status last verified
- Oct 2025
- First submitted
- 3 May 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including questionnaire responses, pain scores, and functional outcomes) will be made available upon reasonable request to qualified researchers. Data will be shared after publication of the main study results. Requests must include a research proposal and be approved by the study investigators. Data will be shared under a data use agreement to ensure confidentiality and compliance with Danish data protection regulations.
Publications
Ahlstrom L, Grimby-Ekman A, Hagberg M, Dellve L. The work ability index and single-item question: associations with sick leave, symptoms, and health--a prospective study of women on long-term sick leave. Scand J Work Environ Health. 2010 Sep;36(5):404-12. doi: 10.5271/sjweh.2917. Epub 2010 Apr 7.
PubMed 20372766Rashid M, Heiden M, Nilsson A, Kristofferzon ML. Do work ability and life satisfaction matter for return to work? Predictive ability of the work ability index and life satisfaction questionnaire among women with long-term musculoskeletal pain. BMC Public Health. 2021 Mar 24;21(1):584. doi: 10.1186/s12889-021-10510-8.
PubMed 33761910Pedersen MH, Duncan P, Lasgaard M, Friis K, Salisbury C, Breinholt Larsen F. Danish validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and findings from a population health survey: a mixed-methods study. BMJ Open. 2022 Jan 3;12(1):e055276. doi: 10.1136/bmjopen-2021-055276.
PubMed 34980626Duncan P, Murphy M, Man MS, Chaplin K, Gaunt D, Salisbury C. Development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ). BMJ Open. 2018 Apr 12;8(4):e019413. doi: 10.1136/bmjopen-2017-019413.
PubMed 29654011Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
PubMed 23184421Sorensen J, Davidsen M, Gudex C, Pedersen KM, Bronnum-Hansen H. Danish EQ-5D population norms. Scand J Public Health. 2009 Jul;37(5):467-74. doi: 10.1177/1403494809105286. Epub 2009 Jun 17.
PubMed 19535407Soer R, Reneman MF, Speijer BL, Coppes MH, Vroomen PC. Clinimetric properties of the EuroQol-5D in patients with chronic low back pain. Spine J. 2012 Nov;12(11):1035-9. doi: 10.1016/j.spinee.2012.10.030.
PubMed 23199409Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.
PubMed 16110932Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PubMed 15621359Song CY, Lin SF, Huang CY, Wu HC, Chen CH, Hsieh CL. Validation of the Brief Pain Inventory in Patients With Low Back Pain. Spine (Phila Pa 1976). 2016 Aug 1;41(15):E937-E942. doi: 10.1097/BRS.0000000000001478.
PubMed 26839985Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
PubMed 14583691Sapra A, Bhandari P, Sharma S, Chanpura T, Lopp L. Using Generalized Anxiety Disorder-2 (GAD-2) and GAD-7 in a Primary Care Setting. Cureus. 2020 May 21;12(5):e8224. doi: 10.7759/cureus.8224.
PubMed 32582485Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workpackage 1: Baseline Prevalence and Implications of Multimorbidity for the Management of Spinal Pain Workpackage 2: The Influence of Multimorbidity Treatment Burden on Long-term Prognosis of Individuals With Spinal Pain
- ClinicalTrials.gov ID
- NCT06402409
- Acronym / sponsor ID
- F2023-169
- Keywords
- Multimorbidity, Comorbidities, Comorbidity, Neck Pain, Back Pain, Spinal pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Jacob Christiansen GandløseUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 May 2024 (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.
Spinal pain is frequently accompanied by other chronic conditions (multimorbidity) and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions.
Therefore the aims of the two studies are to:
Work package 1 - Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics. Examine associations with relevant health-related factors and cover the significance of multimorbidity in the diagnostic process, referral patterns and healthcare utilization.
Work package 2: Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation.
Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital (AaUH) or the Medical Spine Clinic in Silkeborg (MSCS).
Detailed description
Background:
Spinal pain is frequently accompanied by other chronic conditions (multimorbidity) and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions.
Objectives:
Work package 1: Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics. Examine associations with various health-related factors and cover the significance of multimorbidity in the diagnostic process, referral patterns and healthcare utilization.
Work package 2: Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation.
Methods:
The project consists of two work packages: A cross sectional study (Work package 1) and a prospective observational cohort study (Work package 2).
Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital (AaUH) or the Medical Spine Clinic in Silkeborg (MSCS). In work package 1 patients with scheduled appointments at the Departments are identified via the hospital's electronic booking system. Secure questionnaires are sent via E-Boks.
Data for the work packages will be collected through the hospital's electronic journal systems, patient-reported outcome measures (PROMs) and external danish registers. PROMS will be collected with REDCap at baseline and 3, 6, and 12 months after the initial consultation in the outpatient clinics. The patients' unique civil registration number (CPR) will be linked to external Danish registries facilitated by the Danish Civil Registration System (CRS).
Variables:
Electronic questionnaires: Name, CPR number, Marital status, Height and weight, Smoking and alcohol habits, and PROMS (elaborated elsewhere)
Medical records: Past and current medication use, referral source (general practitioner, specialist, hospital), Past treatment attempts (physiotherapy, chiropractic, etc.), Information on any scans performed (if any), Signs of radiculopathy, Number of consultations.
External registries:
- "The Danish Civil Registration System": Age, sex, Migration status, Vital status.
- "The Danish National Patient Registry": Concurrent diseases (ICD-10 codes), Period from referral date to treatment start date, Start and end dates of outpatient treatment.
- "The Danish National Prescription Registry": All dispensed medications from Danish pharmacies (ATC codes).
- "The Population Education Register": Highest completed level of education (short, medium, long)
- "DREAM database": Income status and public financial support.
Statistical considerations:
Work package 1: A cross-sectional study
Prevalence of multimorbidity and frequency of other diseases will be reported as percentages and total counts and presented in a table. Regression analysis will be emplyed to determine whether the number of chronic conditions or specific clusters of chronic conditions are associated with the primary outcome, EQ-5D-5L, other patient-reported measures, and use of healthcare services. Additionally, patients will be divided into groups categorized by the Multimorbidity Treatment Burden Questionnaire following the classification established by Duncan et al. These categories will divide participants into four distinct categories: no burden (score 0), low burden (score <10), medium burden (score 10-22), and high burden (score ≥22). Analysis of Covariance (ANCOVA) will be employed to determine whether there are statistically significant differences in EQ-5D-5L scores between the groups while accounting for potential confounding covariates. Individual plots will be generated to visually depict the distribution of patient scores on EQ-5D-5L and Brief Pain Inventory across the four groups.
Work package 2: An observational prospective cohort study
As in work package 1, patients will be categorized into groups based on their baseline treatment burden. Mixed model with repeated measures will be utilized to determine whether there are statistically significant differences in EQ-5D-5L scores and BPI-scores between groups over time (baseline, 3-6-12 months follow-up), while accounting for potential confounding covariates. Line graphs with error bars will be generated to visually depict the changes in EQ-5D-5L and BPI across the four groups.
For both workpackages missing data will be addressed by multiple imputation or other means if not deemed appropiate. The imputation model will be informed by existing literature and by a dropout analysis. In addition, the selection of covariates for inclusion in the statistical models will be guided by current evidence and clinical reasoning to account for potential confounding factors.
In assessing the prevalence of multimorbidity, it is defined as the presence of two concurrent chronic diseases in a single individual. To discern which ICD-10 codes correspond to chronic health conditions, a unique script has been devised. This script draws from previous studies, particularly those focused on determining multimorbidity prevalence, and incorporates recommendations from international consensus on multimorbidity measurement in research. The validation of ICD-10 codes in the Danish National Patient Registry (DNPR) and the Primary Care Referral Registry (PCRR) has been systematically conducted across various diagnoses and studies, affirming their accuracy for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: No treatment burden | – | –Individuals scoring a total of 0 points on the Multimorbidity Treatment Burden Questionnaire, reflecting no perceived treatment burden. |
| Group 2: Low treatment burden | – | –Individuals scoring a total of below 10 points (but over 0) on the Multimorbidity Treatment Burden Questionnaire, reflecting low perceived treatment burden. |
| Group 3: Medium treatment burden | – | –Individuals scoring a total of between 10 and 22 points on the Multimorbidity Treatment Burden Questionnaire, reflecting medium perceived treatment burden. |
| Group 4: High treatment burden | – | –Individuals scoring a total of over 22 points on the Multimorbidity Treatment Burden Questionnaire, reflecting high perceived treatment burden. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred with spinal pain to Aalborg University Hospital's Department of Rheumatology or the Medical Spine Clinic in Silkeborg during the recruitment time.
Key inclusion criteria (4 listed)
- 18 years old or above
- Are diagnosed with neck or back pain
- Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)
- Speak, read and understand Danish
Key exclusion criteria (1 listed)
- Withdraw consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health related quality of life
Time frame: EQ-5D-5L will be collected at baseline, 3, 6, and 12 months of follow-up.
The EQ-5D-5L questionnaire is a standardized measure of health-related quality of life recommended for multimorbidity research. The EQ-5D-5L assesses health status across five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-point ordinal scale ranging from 1 (indicating no problems) to 5 (indicating extreme difficulties) The EQ-5D index score can be regarded as a continuous outcome and ranges from -0.624 to 1, with higher scores indicating better general health and quality of life.
1 secondary outcome
Brief Pain Inventory
Time frame: BPI will be collected at baseline, 3, 6, and 12 months of follow-up.
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 14 Apr 2026.
- Background: PubMed 20372766Ahlstrom L, Grimby-Ekman A, Hagberg M, Dellve L. The work ability index and single-item question: associations with sick leave, symptoms, and health--a prospective study of women on long-term sick leave. Scand J Work Environ Health. 2010 Sep;36(5):404-12. doi: 10.5271/sjweh.2917. Epub 2010 Apr 7.
- Background: PubMed 33761910Rashid M, Heiden M, Nilsson A, Kristofferzon ML. Do work ability and life satisfaction matter for return to work? Predictive ability of the work ability index and life satisfaction questionnaire among women with long-term musculoskeletal pain. BMC Public Health. 2021 Mar 24;21(1):584. doi: 10.1186/s12889-021-10510-8.
- Background: PubMed 34980626Pedersen MH, Duncan P, Lasgaard M, Friis K, Salisbury C, Breinholt Larsen F. Danish validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and findings from a population health survey: a mixed-methods study. BMJ Open. 2022 Jan 3;12(1):e055276. doi: 10.1136/bmjopen-2021-055276.
- Background: PubMed 29654011Duncan P, Murphy M, Man MS, Chaplin K, Gaunt D, Salisbury C. Development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ). BMJ Open. 2018 Apr 12;8(4):e019413. doi: 10.1136/bmjopen-2017-019413.
- Background: PubMed 23184421Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
- Background: PubMed 19535407Sorensen J, Davidsen M, Gudex C, Pedersen KM, Bronnum-Hansen H. Danish EQ-5D population norms. Scand J Public Health. 2009 Jul;37(5):467-74. doi: 10.1177/1403494809105286. Epub 2009 Jun 17.
- Background: PubMed 23199409Soer R, Reneman MF, Speijer BL, Coppes MH, Vroomen PC. Clinimetric properties of the EuroQol-5D in patients with chronic low back pain. Spine J. 2012 Nov;12(11):1035-9. doi: 10.1016/j.spinee.2012.10.030.
- Background: PubMed 16110932Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.
- Background: PubMed 15621359Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
- Background: PubMed 26839985Song CY, Lin SF, Huang CY, Wu HC, Chen CH, Hsieh CL. Validation of the Brief Pain Inventory in Patients With Low Back Pain. Spine (Phila Pa 1976). 2016 Aug 1;41(15):E937-E942. doi: 10.1097/BRS.0000000000001478.
- Background: PubMed 14583691Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
- Background: PubMed 32582485Sapra A, Bhandari P, Sharma S, Chanpura T, Lopp L. Using Generalized Anxiety Disorder-2 (GAD-2) and GAD-7 in a Primary Care Setting. Cureus. 2020 May 21;12(5):e8224. doi: 10.7759/cureus.8224.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including questionnaire responses, pain scores, and functional outcomes) will be made available upon reasonable request to qualified researchers. Data will be shared after publication of the main study results. Requests must include a research proposal and be approved by the study investigators. Data will be shared under a data use agreement to ensure confidentiality and compliance with Danish data protection regulations.
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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 Back Pain and Neck Pain, run by Jacob Christiansen Gandløse at 1 site in Denmark.
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 4 inclusion and 1 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 14 Apr 2026. 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 Denmark. 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 Jacob Gandløse, PhD Student (50998483, j.gandloese@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: EQ-5D-5L will be collected at baseline, 3, 6, and 12 months of follow-up.). 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 NCT06402409, which also lists 13 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 14 Apr 2026.