Effect of ischemic compression associated with exercise in individuals with non-specific chronic neck pain: a randomized sham-controlled clinical trial

• Grant number: 25/16407-0
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: December 01, 2025
• End date: May 31, 2029
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Luiz Fernando Approbato Selistre
• Grantee: Maria Ramela Schalch Vivaldini
• Host Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil

Abstract

Introduction: Individuals with non-specific chronic neck pain may experience myofascial pain caused by myofascial trigger points (MTrPs) and alterations in central pain processing. Therapeutic exercises and manual therapy, such as ischemic compression (IC), are recommended, but the combination of these two approaches has been little explored. Furthermore, studies comparing active interventions with sham are essential to assess the true efficacy of manual therapy techniques, where placebo effects may influence outcomes. Objective: To compare the effect of IC combined with exercise versus sham IC combined with exercise in individuals with non-specific chronic neck pain. Methods: A randomized controlled clinical trial with 122 participants aged between 18 and 65 years who have experienced neck pain for more than 3 months will be conducted. Participants will be randomly assigned to one of two groups (treatment group [TG] and sham group [SG]) and will receive interventions for 8 weeks-twice a week in person and once a week asynchronously via remote sessions. Primary outcomes include pain intensity in the past 24 hours and disability measured by the Neck Disability Index (NDI). Secondary outcomes include range of motion, global perceived effect scale, patient satisfaction, and treatment adherence. Pain processing measures will also be assessed, such as pressure pain threshold (PPT), temporal summation (TS), and conditioned pain modulation (CPM), as well as pain catastrophizing and sleep quality. Assessments will be conducted at baseline, after 8 weeks of treatment, and at 1- and 6-month follow-ups. Statistical Analysis: Linear mixed models will be used to compare the long-term effects of the interventions, including the interaction between group (TG and SG) and time (baseline, post-intervention at 8 weeks, 1-month and 6-month follow-ups). Additionally, exploratory multiple linear regression models will be used to investigate whether PPT, TS, and CPM are significant mediators of the primary outcomes, and whether sleep quality and pain catastrophizing are predictors of pain intensity and disability.Objective: To compare the effect of IC combined with exercise versus sham IC combined with exercise in individuals with non-specific chronic neck pain.Methods: A randomized controlled clinical trial will be conducted with 96 participants aged between 18 and 65 years who have experienced neck pain for more than 3 months. Participants will be randomized into two groups (treatment group [TG] and sham group [SG]) and will receive interventions over 8 weeks: two sessions per week delivered asynchronously online and one session per week delivered in person.The primary outcomes are pain intensity in the last 24 hours and disability measured by the Neck Disability Index. The secondary outcomes include range of motion, Global Perceived Effect scale, patient satisfaction, and treatment adherence. Pain processing measures will also be assessed, including pressure pain threshold (PPT), temporal summation (TS), and conditioned pain modulation (CPM), as well as pain catastrophizing and sleep quality. Assessments will be conducted at baseline, after 8 weeks of treatment, and at 1- and 6-month follow-ups.Statistical analysis: Mixed linear models will be used to compare the long-term effects of the interventions, with interaction between groups (TG and SG) and time (baseline, post-intervention at 8 weeks, and 1- and 6-month follow-ups). Additionally, exploratory and secondary multiple linear regression models will be used to investigate whether PPT, TS, and CPM are significant mediators of the primary outcomes, and whether sleep quality and pain catastrophizing are predictors of pain intensity and disability. (AU)