No registrations found.
ID
Source
Brief title
Health condition
Acute non-specific neck pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
Latent trajectories whereby participants will be categorized based on their 2-, 4-, 6- weeks and 3-, 6- months NPRS and NDI score.
Secondary outcome
The participants will be checked for differences between trajectories in inflammatory markers, psychosocial factors, clinical characteristics and treatment related factors. Questionnaires will be filled in using paper questionnaires.
Inflammatory markers: Serum levels of high-sensitive CRP, TNF-α and salivary cortisol awakening response (CAR).
Psychosocial: catastrophising (PCS), anxiety, depression, stress (DASS21), sleep (PSQI), work, sports, physical activity (IPAQ), Illness perception (IPQ), kinesiophobia (Tampa).
Clinical characteristics: pain intensity (NPRS), disability (NDI), pain pressure threshold (PPT), wind-up, condition pain modulation (CPM), global perceived effect (GPE), range of motion (CROM).
Treatment related factors: Given treatment, number of treatments, medication use, used diagnostics (e.g. MRI, X-ray).
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
We hypothesize that there will be different trajectories related to recovery in acute neck pain patients and that several biological, psychosocial and treatment related factors are associated with distinct trajectories. We hypothesize that the recovery trajectory will be associated with an early robust inflammatory response with intact cortisol awakening response (CAR). The non-recovery trajectory will be associated with ongoing inflammatory responses, a reduced CAR and more psychosocial discomfort compared to the recovery trajectory. In the current study we will use advances in biomedical and psychosocial assessment techniques to explore a range of characteristics from patients with acute neck pain. This exploratory study builds further on very recent developments within pain science and can lead to a subsequent study with more participants.
Study design
All inflammatory markers, clinical characteristics and psychosocial assessments will be performed at baseline (T0), two weeks evaluation (T1), four weeks evaluation (T2), six weeks evaluation (T3), three months evaluation (T4) and six months evaluation (T5).
Intervention
Participants will not receive any treatment in the context of the present study. However, they are free to consume usual care conservative treatment such as physiotherapy or general practitioner care or self care. The number and modality of treatments will be recorded. We are interested in the different trajectories in the clinical course of people with neck pain. If the patients fits the inclusion/exclusion criteria the participant is eligible with or without treatment.
Inclusion criteria
Non-specific neck pain patients 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, 4) having sufficient knowledge of the Dutch language.
Exclusion criteria
A potential participant who meets any of the following criteria will be excluded from participation in this study:
• Pregnancy or postpartum for not more than 9 months or those who give breastfeeding;
• Contra-indications for venipuncture (e.g. phlebitis);
• 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
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8892 |
| Other | METC Brabant : Not yet received. |