Contextual Factors-Enriched Standard Care on Mechanical Neck Pain

NCT06361472 | Recruiting

• 1 other identifier: 11695
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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

Conditions

Neck Pain

Keywords

neck pain; functional status; contextual factors; placebo; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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).

  4 weeks and 12 weeks after end of treatment

• Neck Disability

  Neck disability will be measured using the Argentinian version of the Northwick Park Neck Pain Questionnaire (NPQ-AR) (Aguirre et al., 2013). The questionnaire has 9 items relating to daily activities (personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation) and cervical spine pain. Each item is scored from 0 to 4, the total score is 36; higher scores represent higher pain or disability.

  4 weeks and 12 weeks after end of treatment

Secondary Outcomes (5)

• Active Range of Movement

  4 weeks and 12 weeks after end of treatment

• Global Rating of Change

  4 weeks and 12 weeks after end of treatment

• Satisfaction with treatment

  4 weeks and 12 weeks after end of treatment

• Expectations

  At baseline, at the end of week 2 (session 5), and at the conclusion of week 4 (session 9).

• Credibility

  At baseline, at the end of week 2 (session 5), and at the conclusion of week 4 (session 9).

Study Arms (2)

Standard Care (SC)

ACTIVE COMPARATOR

Treatment will be carried out based on the mechanical neck pain clinical practice guideline. Physiotherapists treating this group of patients will avoid enhancing the contextual factors mentioned in the intervention group.

Other: Standard Care

Contextual Factors-Enriched Standard Care (CFs+SC)

EXPERIMENTAL

Treatment will be carried out based on the mechanical neck pain clinical practice guideline. Additionally, Contextual Factors, which include physical, psychological, and social elements involved in the clinical encounter between the patient and the physiotherapist, will be deliberately enhanced in this group.

Other: Standard Care; Behavioral: Contextual Factors

Interventions

Standard Care OTHER

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).

Also known as: SC

Contextual Factors-Enriched Standard Care (CFs+SC); Standard Care (SC)

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.

Also known as: CFs

Contextual Factors-Enriched Standard Care (CFs+SC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• Universidad Nacional de la Matanza: lead

Study Sites (2)

Hospital Carlos G. Durand

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1405, Argentina

RECRUITING

Hospital Donación Francisco Santojanni

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1408, Argentina

RECRUITING

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MeSH Terms

Conditions

Neck Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mauro F Andreu, PhD

  Universidad Nacional de la Matanza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro F Andreu, PhD

CONTACT

(+54) 11 6878-8298; mfandreu@gmail.com

Federico J Villalba, PT

CONTACT

(+54) 11 3324-9413; federicojosevillalba@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study, blinding of both therapists and patients will not be feasible. However, to uphold the scientific validity of the study, specific descriptors and methodological details, such as terms like "placebo" or "CFs," have been intentionally excluded from the consent disclosure. To prevent any potential bias in participants' perceptions, information regarding the potential involvement of CFs in outcomes will not be provided. Instead, participants will be informed that the study aims to assess changes resulting from standard treatment for MNP. The person in charge of data statistical analysis and the evaluators who will assess all participants' pre- and post-intervention assessments will be blinded to the allocated intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Mauro Federico Andreu, PhD

Model Details: The ContextualizAR trial is designed as a two-arm, randomized, controlled, and blinded assessor superiority trial conducted at two centers. Patients will be allocated to one of two groups: a CFs+SC group and the SC group.

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2)