Back complaints in the elderly: clinical course and prognostic factors.

Back complaints in the elderly: clinical course and prognostic factors. - Back complaints in the elderly

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35201

Enrollment

1000

Registered

2009-03-23

Start date

2009-04-14

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

back ache back pain

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients, older than 55 years, who visit their GP in the region of Rotterdam with a new episode of back pain (from mid-thoracic downwards). A new episode of back pain is defined as current back pain, preceded by a period of 6 months without consulting the GP for similar complaints.

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they do not have enough cognitive capacities to fill out the questionnaires (f.e. due to dementia) or have difficulties speaking and writing the Dutch language. Patients that have severe mobility impairments (f.e. are wheelchair bound) are excluded as well.

Design outcomes

Primary

Measure	Time frame
The primary outcome measures are back pain (NRS), disability (Roland Disability Questionnaire RDQ; loss of productivity (PRODISQ)), quality of life (short form 36 (SF-36)) and self-perceived recovery (7-point scale).	—

Secondary

Measure	Time frame
To identify possible predictive prognostic factors, information will be collected on demographics (age, gender, ethnicity, smoking, alcohol use, education, type of job and marital status), co-morbidity (self-administered comorbidity questionnaire (SCQ) and GP charts), depression (depression scale (CES-D)), kinesiophobia (fear avoidance beliefs questionnaire (FABQ), pain catastrophizing (PCS), back beliefs (back beliefs questionnaire, BBQ), pain response to activities and position (PRAP), widespread pain (ACR-criteria), sleep quality, expectations on recovery (5-point scale), medical consumption, physical activity (IPAQ-short), physical workload (Dutch musculoskeletal questionnaire (DMQ)), and satisfaction with job, with health care and with the patients* current physical condition (5-point scale). During a physical exam, neurological symptoms, muscle strength, spinal deformities, bone mineral density (heel densitometry), infection markers (CRP, c-reactive protein), mobility (timed-up-and-go and 10m walking test), as well as the presence of red flag symptoms and the history of back pain will be further assessed. Vertebral degeneration will be quantified based on X-rays. Underlying severe pathology (malignancy, infection, fracture, severe neurological compromise, inflammatory spondylarthritis) will be registered based on GP charts. In order to be able to perform additional analyses such as genetic polymorphisms in a later phase of the study the remaining blood samples will be kept frozen and stored.	—

Measure

Time frame

To identify possible predictive prognostic factors, information will be collected on demographics (age, gender, ethnicity, smoking, alcohol use, education, type of job and marital status), co-morbidity (self-administered comorbidity questionnaire (SCQ) and GP charts), depression (depression scale (CES-D)), kinesiophobia (fear avoidance beliefs questionnaire (FABQ), pain catastrophizing (PCS), back beliefs (back beliefs questionnaire, BBQ), pain response to activities and position (PRAP), widespread pain (ACR-criteria), sleep quality, expectations on recovery (5-point scale), medical consumption, physical activity (IPAQ-short), physical workload (Dutch musculoskeletal questionnaire (DMQ)), and satisfaction with job, with health care and with the patients* current physical condition (5-point scale). During a physical exam, neurological symptoms, muscle strength, spinal deformities, bone mineral density (heel densitometry), infection markers (CRP, c-reactive protein), mobility (timed-up-and-go and 10m walking test), as well as the presence of *red flag* symptoms and the history of back pain will be further assessed. Vertebral degeneration will be quantified based on X-rays. Underlying severe pathology (malignancy, infection, fracture, severe neurological compromise, inflammatory spondylarthritis) will be registered based on GP charts. In order to be able to perform additional analyses such as genetic polymorphisms in a later phase of the study the remaining blood samples will be kept frozen and stored.

—

Countries

Netherlands

Outcome results