A Two-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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 94
- Locations
- 3
- Primary Endpoint
- Neck Pain Intensity
Study Overview
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.
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 recruitment site, 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 personnel 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 and the evaluators who will assess all participants' pre- and post-intervention assessments will be blinded to the allocated intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Standard Care (Other)
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.
Intervention: Standard Care (Other)
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.
Intervention: Contextual Factors (Behavioral)
Outcomes
Primary Outcomes
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).
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.
Secondary Outcomes
- Active Range of Movement(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).)
- Global Rating of Change(4 weeks and 12 weeks after end of treatment)
Investigators
Mauro Federico Andreu
Prof. Mauro Federico Andreu, PhD
Universidad Nacional de la Matanza