Exploring Multimorbidity in Patients With Spinal Pain

NCT06402409 | Recruiting

• 1 other identifier: F2023-169
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Back Pain; Neck Pain; Comorbidities and Coexisting Conditions

Keywords

Multimorbidity; Comorbidities; Comorbidity; Neck Pain; Back Pain; Spinal pain

Outcome Measures

Primary Outcomes (1)

• 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.

  EQ-5D-5L will be collected at baseline, 3, 6, and 12 months of follow-up.

Secondary Outcomes (1)

• Brief Pain Inventory

  BPI will be collected at baseline, 3, 6, and 12 months of follow-up.

Other Outcomes (7)

• Multimorbidity Treatment Burden Questionnaire (MTBQ)

  MTBQ will be collected at baseline, 3, 6, and 12 months of follow-up.

• Selected items from work ability index

  The selected items from WAI will be collected at baseline, 3, 6, and 12 months of follow-up.

• Insomnia Severity Index

  ISI will be collected at baseline, 3, 6, and 12 months of follow-up.

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Withdraw consent

Sponsors & Collaborators

• Jacob Christiansen Gandløse: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Publications (13)

• 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.

  PMID: 20372766 BACKGROUND

• Rashid 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.

  PMID: 33761910 BACKGROUND

• Pedersen 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.

  PMID: 34980626 BACKGROUND

• Duncan 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.

  PMID: 29654011 BACKGROUND

• Janssen 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.

  PMID: 23184421 BACKGROUND

• Sorensen 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.

  PMID: 19535407 BACKGROUND

• Soer 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.

  PMID: 23199409 BACKGROUND

• Walters 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.

  PMID: 16110932 BACKGROUND

• Dworkin 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.

  PMID: 15621359 BACKGROUND

• Song 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.

  PMID: 26839985 BACKGROUND

• Kroenke 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.

  PMID: 14583691 BACKGROUND

• Sapra 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.

  PMID: 32582485 BACKGROUND

• Bastien 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.

  PMID: 11438246 BACKGROUND

MeSH Terms

Conditions

Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jacob Gandløse, PhD Student

CONTACT

50998483; j.gandloese@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)