Clinical trial NCT02188030: Individual and Group Exercise Program for Industrial Workers With CANS: Randomized Controlled 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Disorder of the Neck
Keywords: musculoskeletal symptom
industrial workers
physical-activity program
resistance training
randomized controlled trial
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnose of nontraumatic complaints of the arm, neck or shoulder with minimum intensity of 4 points on the visual analogue pain scale1, for at least 6 weeks2.

Exclusion Criteria:

* Participants with contraindication to physical exercise
* Participants who had been diagnosed with cervical disc hernia; shoulder instability; fractures; frozen shoulder; systemic diseases such as rheumatoid arthritis or diabetes; neurological diseases or other severe medical or psychiatric disorders

Primary outcomes:
measure: Change in pain intensity during and after treatment
timeFrame: 6th and 12th week after the start of treatment
Secondary outcomes:
measure: Global Impression of Recovery
timeFrame: 6th and 12th week after treatment
measure: Disability
timeFrame: Baseline, 6th and 12th week after treatment
Other outcomes:
Locations:
city: Itabuna
country: Brazil
facility: União Metropolitana de Ensino e Cultura (UNIME)
state: Bahia
Study officials:
affiliation: Universidade Cidade de São Paulo (UNICID)
name: Rosimeire Padula, Doctor
role: PRINCIPAL_INVESTIGATOR
References: