The objective of the current study is two-fold. First, to identify the duration and severity of back pain in the elderly. Second, to identify possible predictive prognostic factors for developing chronic back pain.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Back pain is the most common musculoskeletal complaint in the elderly and
induces profound disability and economical costs. However, the clinical course
of back pain in the elderly remains largely unknown. Furthermore, the presence
of underlying pathology, and the predictive prognostic factors for developing
chronic back pain have received little scientific attention.
Study objective
The objective of the current study is two-fold. First, to identify the duration
and severity of back pain in the elderly. Second, to identify possible
predictive prognostic factors for developing chronic back pain.
Study design
In a prospective cohort design, 1000 patients will be followed for a period of
1 year. All patients will undergo a standardised physical examination, X-ray
investigation, and will fill-out a questionnaire at baseline, based on the
MMICS proposal. At 6 weeks and 3, 6, 9, 12, 24, 36, 48 and 60 months after
inclusion, patients will fill-out follow-up questionnaires. At 5 years
follow-up all patients will undergo a X-ray of their back, similar as the
baseline.
Study burden and risks
The risks and burden for the patient are relatively minor. Patients are
required to pay a single visit to a research location in their vicinity.
Furthermore, they undergo a physical examination, a venapunction, X-ray
investigation ( at baseline and at 5 years follow-up) and are required to fill
out several questionnaires. This will cost the patient a total of 6 hours over
the duration of 5 years. The patients will be guided throughout the study and
assistance with filling out the questionnaires can be provided. The information
that the study will collect will probably aid in the earlier detection and
better treatment of chronic back complaints in the elderly. A complaint which
is generally considered to be very disabling.
postbus 2040
3000 CA Rotterdam
NL
postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24829.078.08 |