Different trajectories for people with acute neck pain: associations with biological, psychosocial and treatment-related factors.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29268

Enrollment

Registered

2020-08-27

Start date

2020-10-25

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Acute non-specific neck pain

Interventions

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

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Latent trajectories whereby participants will be categorized based on their 2-, 4-, 6- weeks and 3-, 6- months NPRS and NDI score.	—

Secondary

Measure	Time frame
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-a 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).	—

Measure

Time frame

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-a 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).

—

Contacts

Public ContactIvo Lutke Schipholt

i.j.m.lutkeschipholt@vu.nl0031683995807

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)