Contextual Factors-Enriched Standard Care on Mechanical Neck Pain

March 24, 2025 updated by: Mauro Federico Andreu, Universidad Nacional de la Matanza

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this study is to determine if a Contextual Factors-Enriched Standard Care (CFs+SC) approach is an effective treatment for MNP in terms of reducing pain and improving function. We hypothesize that a 4-week Contextual Factors-Enriched Standard Care will be superior to Standard Care alone in terms of patient-reported disability and pain, with measurements conducted using the Argentine version of the Northwick Park Neck Pain Questionnaire (NPQ-AR) and the Numerical Pain Rating Scale (NPRS), respectively.

The secondary aims are:

  • To determine whether CFs+SC is more effective than SC in terms of active range of motion (ROM) enhancement, global perceived effect (GROC), and satisfaction with treatment after the 4-week intervention.
  • To determine if a CFs+SC approach is effective in treating MNP in terms of disability improvement, pain reduction, active ROM enhancement, global perceived effect (GROC), and satisfaction with treatment 12 weeks after a 4-week treatment plan.
  • To explore differences in treatment credibility and expectations between the CFs+SC group and the SC group at both the 2-week and 4-week intervals.
  • To investigate whether individuals identified with at least one negative psychosocial condition (such as anxiety, fear of movement, stress, catastrophizing, and depression) will experience greater benefits from the CFs+SC intervention compared to those without negative psychosocial conditions.

Consecutive patients meeting all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to either the CFs+SC group or the SC alone group. Randomization will employ a blocked design with variable block lengths (2:4) and will be stratified based on baseline pain ('mild-moderate' or 'severe,' determined by whether they report between 3 and 7 points or ≥ 8 points on the baseline NPRS, respectively) and participants' expectations ('high' or 'low') regarding the effectiveness of standard care treatment.

The randomization process will be generated and conducted by SS and PP, who will not be involved in data analysis or patient enrollment. The website www.randomization.com will be used for this process. To maintain allocation concealment during the study, sequential, numbered, and sealed opaque envelopes will be utilized. Patients will be allocated to one of two groups: a CFs+SC group and the SC group. Due to the nature of the study, blinding of both therapists and patients will not be feasible. The person in charge of data statistical analysis (FV) and the evaluators who will assess all participants' pre- and post-intervention assessments (MLL and AR) will be blinded to the allocated intervention.

Both groups will undergo 4 weeks of standard care twice weekly following established clinical practice guidelines, and including exercises, mobilization, manual therapy, education, and a neck wellness home care guide. In the intervention group, CFs will be enhanced, encompassing the physical, psychological, and social elements inherent in the clinical encounter, based on existing evidence.

At the onset of treatment, patients will receive a schedule outlining the dates of the next 8 visits. One day before each session, an individual not involved in the study will send a text message (SMS) reminder. Should a scheduled session be missed, it will be rescheduled. However, patients who miss two consecutive scheduled sessions will be deemed dropouts and analyzed using the intention-to-treat (ITT) approach, with the last observed value taken into consideration. Additionally, participants will be asked to refrain from undergoing any other treatments until the end of the 12-week follow-up period. During this period, participants are only permitted to adhere to the NWHCG. If a participant reports undergoing any other treatments, they will be considered as dropouts and analyzed using the ITT approach.

Physiotherapists will undergo a comprehensive training program comprising 8 hours of formal instruction, tailored to provide the necessary skills and proficiency for both therapeutic contexts under investigation. To ensure treatment fidelity, a Manual of Treatment (MOT) was developed. Therapist adherence to the MOT will be evaluated through self-assessment ratings provided by the therapists themselves. After each session, therapists will rate their adherence to the manual using a form specifically designed for this study. Additionally, monthly audits will assess compliance with the MOT, and frequent meetings with providers will be held to mitigate any deviations in provider adherence to the MOT, ensuring its consistency over time.

The sample size for this study was determined using a linear mixed effects model to account for within-subject correlation arising from repeated measures over time. The model includes fixed effects, such as treatment group (CF+SC and SC groups), and time points (baseline, 4 weeks, and 12 weeks after treatment), along with the interaction between treatment group and time to assess potential changes in treatment effects over time. Random effects for individual subjects were also included to address repeated measures within the same subjects. Based on an assumed medium effect size (f2 = 0.15), 80% power, and a significance level of 0.05 (two-tailed), the estimated sample size required for this study was calculated to be 85 subjects. To accommodate a projected dropout rate of 10%, the sample size was adjusted, resulting in a final target sample size of 94 subjects (47 participants per group).

Outcomes will be analyzed on an ITT basis, with reporting of sample characteristics and descriptive statistics. Linear mixed models will be used for primary analysis to verify the differences between the average effects of interventions (CFs+SC and SC) in reassessments carried out 4 weeks after random allocation and 12 weeks after treatment. The differences between groups will be calculated by interaction terms of groups versus time. All statistical procedures will be performed using SPSS, developed by SPSS Inc., Chicago, IL, USA.

Trial procedures and evaluations will be conducted by trained personnel (MLL, AR, MM, GD, and FR) using paper-based Case Report Forms (CRFs), with implemented quality control measures. Subsequently, MM, GD, and FR will enter the data into an electronic database using MAWE® Data Collection Tools (www.mawetools.com). An independent data monitoring committee (MFA, SS, FV, and PP) will oversee the entire data collection process to ensure its quality and integrity. Monitoring of the study will be overseen by MFA and FV, encompassing verification of adherence to predefined inclusion and exclusion criteria, monitoring overall study progress, and ensuring accurate data recording in CRFs. Auditing responsibilities will be carried out weekly by the principal investigator to ensure completeness and accuracy across critical study components, including participant consent forms, paper forms, and recruitment rates.

The trial will be conducted in compliance with the principles of the Declaration of Helsinki, Good Clinical Practice, and all applicable regulatory requirements. Ethical approval has been obtained from the Institutional Review Board (IRB) (#11695, approved on 15/03/2024). The principal investigator and researchers affirm no financial or other competing interests. Access to final trial data will be provided to designated individuals and authorized personnel, with any contractual restrictions transparently disclosed. Upon trial completion, results will be published in peer-reviewed journals, following authorship guidelines established by the ICMJE and CRediT framework.

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1408
        • Recruiting
        • Hospital Donación Francisco Santojanni
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care (SC)
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
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).
Other Names:
  • SC
Experimental: Contextual Factors-Enriched Standard Care (CFs+SC)
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
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).
Other Names:
  • SC
Behavioral: 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.
Other Names:
  • CFs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Pain Intensity
Time Frame: 4 weeks and 12 weeks after end of treatment
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
Time Frame: 4 weeks and 12 weeks after end of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active Range of Movement
Time Frame: 4 weeks and 12 weeks after end of treatment
AROM will be measured with the "clinometer" iPhone and/or Android app as described by Monreal (2021): Cervical flexion, extension, and lateral flexion measurements will be conducted with participants in a seated position
4 weeks and 12 weeks after end of treatment
Global Rating of Change
Time Frame: 4 weeks and 12 weeks after end of treatment
The GROC is designed to quantify a patient's improvement or deterioration over time. It requires the subject to evaluate his or her current health status and compare it to his or her previous condition (Kamper et al., 2009). To assess this construct the 10th question of the NPQ will be used. This item has 5 categories: ''much worse'', "Slightly worse", "The same", "Slightly better" and ''much better'' (Aguirre 2013).
4 weeks and 12 weeks after end of treatment
Satisfaction with treatment
Time Frame: 4 weeks and 12 weeks after end of treatment
Overall treatment satisfaction will be evaluated with question number 11 of the MedRisk questionnaire. (Beattie 2005) Patient will score from 1 (strongly disagree) to 5 (strongly agree), the following sentence: "Overall, I am completely satisfied with the services I receive from my therapist" (Beattie 2005).
4 weeks and 12 weeks after end of treatment
Expectations
Time Frame: At baseline, at the end of week 2 (session 5), and at the conclusion of week 4 (session 9).
Four questions, each corresponding to the specific intervention in the therapeutic plan (active exercises, manual therapy, education, and 'Neck Wellness Home Care Guide'), will be used to assess participants' expectations for the effectiveness of treatment. Participants will respond to the statement: 'I believe [intervention] will significantly help to improve this episode of my neck pain,' using a five-point scale: 'definitely agree,' 'agree,' 'neutral,' 'disagree,' and 'definitely disagree,' with 'neutral' representing the midpoint response (Bishop et al., 2013b).
At baseline, at the end of week 2 (session 5), and at the conclusion of week 4 (session 9).
Credibility
Time Frame: At baseline, at the end of week 2 (session 5), and at the conclusion of week 4 (session 9).
The credibility regarding the treatment will be evaluated by the first three questions of the Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000). The three items addressing therapy credibility relate to: 1) the extent to which the treatment appears logical, 2) the extent to which the treatment appears useful, 3) the confidence with which the patient would recommend the treatment to a friend having the same problem.
At baseline, at the end of week 2 (session 5), and at the conclusion of week 4 (session 9).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de la Matanza

Investigators

  • Principal Investigator: Mauro F Andreu, PhD, Universidad Nacional de la Matanza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11695

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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