Contextual Factors-Enriched Standard Care on Mechanical Neck Pain

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Neck Pain

In brief

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. This study will be conducted at two sites in Buenos Aires, Argentina. Randomization will be stratified by site to ensure balanced allocation across centers.

Key facts

Study ID

NCT06361472

Run by

Universidad Nacional de la Matanza

People needed

94

Starts

2024-05-02

Expected to finish

2027-07-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged >18.
• Neck pain for more than 4 weeks without signs or symptoms suggestive of major structural pathology.
• Read, write, and understand the Spanish language.
• Signed consent form.

You may not qualify if…

• Numeric Pain Reporting Scale (NPRS) < 3 points (to ensure the exclusion of patients with minor disorders).
• Northwick Park Neck Pain Questionnaire (NPQ) < 10 points (to ensure the exclusion of patients with minor disorders).
• History of cervical spine trauma, fracture, or surgical procedures.
• Signs and symptoms of cervical myelopathy and/or cervical radiculopathy (to rule out cervical radicular pain, the Spurling Test, the Upper Limb Tension Test for the median nerve, and the Traction/Distraction test will be used).
• Red flags or serious pathologies, such as malignancy, inflammatory or rheumatic diseases, infections, and vascular conditions like cervical artery insufficiency.

Where it is running

• Hospital Carlos G. Durand — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Hospital Donación Francisco Santojanni — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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