1) Identify and describe different trajectories in the clinical course of people with acute neck pain. 2) Assess which biological-, psychosocial factors and treatments characteristics, differ between, and are most associated with the different…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Latent trajectories of the course of acute neck pain for pain intensity and
disability.
Secondary outcome
The participants will be checked for differences between and associations with
trajectories in inflammatory markers, psychosocial factors, clinical
characteristics and treatment related factors. Questionnaires will be filled in
using paper questionnaires.
Background summary
Preventing persistence of non-specific neck pain will help to reduce the total
burden of neck pain. Acute neck pain can be considered as a complex condition
and several biological- and psychosocial factors interact bi-directionally and
affect recovery. Currently, we are unable to predict who will recover and
detailed information about the clinical course of people with acute neck pain
is lacking. Recent insights show that the level of systemic inflammation and
various psychosocial factors differ between recovered and non-recovered
patients. Since the clinical course of people with acute neck pain is
heterogeneous, it is important to identify different trajectories, and explore
which biological-, psychosocial and treatment related factors are associated
with recovery, and are different compared to non-recovery.
Study objective
1) Identify and describe different trajectories in the clinical course of
people with acute neck pain.
2) Assess which biological-, psychosocial factors and treatments
characteristics, differ between, and are most associated with the different
trajectories.
Study design
Prospective longitudinal cohort study with 6-months follow-up.
Study burden and risks
The participants undergo in total 6 venipunctures of 5 ml each over a period of
6 months. Participants undergo physical tests, filling in questionnaires and
venipunctures at baseline, week 2, week 4, week 6, month 3, and month 6. In
total 30 ml whole blood will be taken. The process of venipuncture can be
accompanied with small discomfort and small haemorrhage. All venipunctures will
be performed by qualified personal with experience in blood taking. In the
morning prior the venipunctures the salivary cortisol awakening response will
be determined. Directly after awakening, 4 times salivary fluid will be
extracted in a time period of one hour. Patients will be followed for a period
of six months and it is allowed to receive treatment as usual during the time
of the study.
Insight in different trajectories in the clinical course of acute neck pain and
the complex interaction with biological-, psychosocial-, and treatment factors
will lead to patient stratification and early insight into those who will
recover poorly. Thanks to the acquired knowledge from this study, healthcare
providers can be educated to deal with such complexity and increase recovery in
the normally non-recovery group. This will reduce the burden of neck pain for
the patient and society. To encounter the participant for any inconvenience 100
euro will be reimbursed after completion of the study. Travel and parking
expenses will be reimbursed. The patients have a minimal of four days to
consider if they want to participate in this study. By shortening the time to
consider participation, it is possible to provide insight into different
trajectories, even in the acute phase of acute pain.
Van der Boechorsstraat 9
Amsterdam 1081BT
NL
Van der Boechorsstraat 9
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
People with non-specific neck pain will be eligible for participation if they
are: 1) at least 18 years old, 2) within 2 weeks of onset of an acute neck pain
episode, 3) lasting for >24h, and 4) having sufficient knowledge of the Dutch
language.
Exclusion criteria
* Pregnancy or postpartum for not more than 9 months or those who give
breastfeeding;
* Contra-indications for venipuncture;
* Taking one of the following medications during the last 6 weeks:
corticosteroids (e.g. prednisone), immunomodulatory medication (e.g.
methotrexate, infliximab) and the use of botox for the last 3 months;
* Current participation in another clinical trial;
* Having a medical disease with immune system involvement (e.g. MS, Spondylitis
Ankylpoetica).
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 | NL75140.028.20 |
| Other | NL8892 |