protocolSection identificationModule nctId: NCT06361472, orgStudyIdInfo id: 11695, briefTitle: Contextual Factors-Enriched Standard Care on Mechanical Neck Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universidad Nacional de la Matanza, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The ContextualizAR trial is designed as a two-arm, randomized, controlled, and blinded assessor superiority trial conducted at a single center. Patients will be allocated to one of two groups: a CFs+SC group and the SC group., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: 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 (FV) and the evaluators who will assess all participants' pre- and post-intervention assessments (MLL and AR) will be blinded to the allocated intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: Standard Care, interventions name: Contextual Factors, outcomesModule primaryOutcomes measure: Neck Pain Intensity, primaryOutcomes measure: Neck Disability, secondaryOutcomes measure: Active Range of Movement, secondaryOutcomes measure: Global Rating of Change, secondaryOutcomes measure: Satisfaction with treatment, secondaryOutcomes measure: Expectations, secondaryOutcomes measure: Credibility, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False