Contextual Factors-Enriched Standard Care on Mechanical Neck Pain

Neck Pain Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361472
• Other study ID #: 11695
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2024
• Source: Universidad Nacional de la Matanza
• Contact: Mauro F Andreu, PhD
• Phone: (+54) 11 6878-8298
• Email: mfandreu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: November 30, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

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).

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de la Matanza

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Active Range of Movement	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
Secondary	Global Rating of Change	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
Secondary	Satisfaction with 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
Secondary	Expectations	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).
Secondary	Credibility	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).