Individual and Group Exercise Program for Industrial Workers With CANS: Randomized Controlled Trial — Exercise  

Musculoskeletal Disorder of the Neck Clinical Trial

Official title: Individual Exercise Program for Industrial Workers With Complaints of the Arm, Neck, or Shoulder (CANS): Study Protocol for a Randomized Controlled Trial.

Status Recruiting

Clinical Trial Summary

This study is double-blinded RCT, whose aim is to assess if an individual exercise program is more effective to reduce complaints in neck, shoulders and arms that an group exercise program, in industrial workers.

The participants will be randomly allocated to receive 12 treatment sessions of individual exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes and will be held twice a week for 12 weeks. Participants will also be encouraged to continue the use of medicines and other health care.

Clinical Trial Description

This study is double-blinded RCT. Participants will be recruited from employees of the companies and industries located in the South of Bahia, Brazil or by referral from general practitioners, orthopedists, This study is single-blinded RCT, whose aim is to assess the efficacy of an individual exercise program for employees with complaints in neck, shoulders and arms. Participants will be recruited from employees of the companies and industries located in Brazil or by referral from general practitioners, orthopedists, neurologists or physiatrists.

The sample of 100 participants was determined by a sample size calculation designed to detect a clinically important difference of 10 points in the DASH Questionnaire (estimated standard deviation = 16,65 points). The following specifications will be considered: α=0.05, statistical power of 80% and follow-up loss of up to 15%.

The participants will be randomly allocated to receive 12 treatment sessions of individual exercise training (IET) or in group exercise training (GET). Sessions will last 30 minutes and will be held twice a week for 12 weeks. Participants will also be encouraged to continue the use of medicines and other health care. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal Disorder of the Neck

• NCT number: NCT02188030
• Study type: Interventional
• Source: Universidade Cidade de Sao Paulo
• Contact: Maria Luiza Comper, Msc.
• Phone: +557388220614
• Email: marialuizacaires21@hotmail.com
• Status: Recruiting
• Phase: N/A
• Start date: June 2014
• Completion date: December 2015