Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361472
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-07
Brief Title:
Contextual Factors-Enriched Standard Care on Mechanical Neck Pain
Sponsor:
Universidad Nacional de la Matanza
Organization:
Universidad Nacional de la Matanza
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 will be an assessor-blinded 2-group 11 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
Detailed Description:
The primary aim of this study is to determine if a Contextual Factors-Enriched Standard Care CFsSC 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 CFsSC 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 CFsSC 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 CFsSC 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 CFsSC 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 11 ratio to either the CFsSC group or the SC alone group Randomization will employ a blocked design with variable block lengths 24 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 wwwrandomizationcom 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 CFsSC 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 CFSC 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 015 80 power and a significance level of 005 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 CFsSC 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 wwwmawetoolscom 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 15032024 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
The secondary aims are
To determine whether CFsSC 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 CFsSC 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 CFsSC 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 CFsSC 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 11 ratio to either the CFsSC group or the SC alone group Randomization will employ a blocked design with variable block lengths 24 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 wwwrandomizationcom 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 CFsSC 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 CFSC 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 015 80 power and a significance level of 005 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 CFsSC 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 wwwmawetoolscom 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 15032024 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None