Contextual Factors-Enriched Standard Care on Mechanical Neck Pain - Trial NCT06361472

Timeline & Enrollment

Primary Outcome

Neck Pain Intensity,Neck Disability

Summary

The primary purpose of this study will be to determine if a CFs-Enriched Standard Care
 approach is an effective treatment for mechanical neck pain in terms of reducing pain and
 improving function. We hypothesize that a 4-week CFs-Enriched Standard Care approach will be
 superior to Standard Care alone in terms of patient-reported disability and pain, with
 measurements conducted using the Northwick Park Neck Pain Questionnaire and the Numeric Pain
 Rating Scale, respectively.
 
 This will be an assessor-blinded, 2-group (1:1) randomized clinical trial aiming to enroll 94
 participants with neck pain persisting for more than 4 weeks. Both groups will undergo 4
 weeks of standard care twice weekly, following established clinical practice guidelines. In
 the intervention group, CFs will be enhanced, encompassing the physical, psychological, and
 social elements inherent in the clinical encounter, based on existing evidence.
 
 The primary outcomes will encompass changes in Pain and Disability after 4 weeks of
 treatment, with a follow-up reassessment at week 12 post-treatment. Secondary outcomes will
 include changes in Active Range of Motion, Global Rating of Change, and Satisfaction with
 treatment. The change between groups after treatment and at the 12-week follow-up will be
 reported for all outcomes, considering the difference from scores recorded at baseline.

ICD-10 Classifications