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Contextual Factors-Enriched Standard Care on Mechanical Neck Pain
Sponsor: Universidad Nacional de la Matanza
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.
Official title: A Single-Center, Investigator-Blinded, Randomized, 4-Week, Parallel-Group, Superiority Study Comparing Contextual Factors-Enriched Standard Care Versus Standard Care Only for Patients with Mechanical Neck Pain (ContextualizAR Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2024-05-02
Completion Date
2026-05-30
Last Updated
2025-03-28
Healthy Volunteers
No
Conditions
Interventions
Standard Care
Standard Care includes exercises, mobilization, manual therapy, education, and Neck Wellness Home Care Guide (NWHCG). The rehabilitation program is based on current clinical practice guidelines aimed at reducing neck pain, improving range of motion, enhancing functionality, and promoting physical activity motivation. Each patient will receive active exercises and manual therapy techniques. Educational components will cover pain science, physical activity benefits, and return to normal activities , supplemented by a NWHCG. Treatment sessions will be conducted, featuring a one-to-one interaction between the participant and the physiotherapist. It will last 4 weeks, with two sessions per week, 45 minutes/session (8 treatment sessions).
Contextual Factors
Bundle of contextual factors divided into three categories: professional, treatment, and healthcare setting features. Regarding the professional contextual factors, they include reputation, appearance, and positive attitudes. The treatment contextual factors encompass positive attitudes, verbal communication, non-verbal communication, empathetic therapeutic alliance, therapeutic touch, and the use of a mirror to show the patient what is being performed. Finally, the healthcare setting contextual factors feature a comfortable setting, adequate environmental conditions, and appropriate design.
Locations (1)
Hospital Donación Francisco Santojanni
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina