Contextual Factors-Enriched Standard Care on Mechanical Neck Pain

ConditionNeck Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversidad Nacional de la Matanza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Standard Care
Other intervention
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
Behavioral
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.

Treatment groups

94 Participants

are divided into 2 treatment groups

Group A: Standard Care (SC)Active comparator 1 intervention

Group B: Contextual Factors-Enriched Standard Care (CFs+SC)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Neck Pain Intensity

Neck pain intensity will be measured using a Numerical Pain Rating Scale (NPRS) composed of an 11-point scale, ranging from 0 ("no pain") to 10 ("the "worst pain imaginable") (Hawker et al., 2011; Kahl \& Cleland, 2005). In this study patients will be asked about their average pain intensity in the last 7 days (Jensen 1999).

Time frame