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

Rosimeire Simprini Padula

Status: Unknown

Conditions: Musculoskeletal Disorder of the Neck

Treatments: Other: Group Exercise Program; Other: Individual Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02188030

480.968

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group Exercise Training (GET).

Active Comparator group

Description:

Group Exercise Program. The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum 12. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.

Treatment:

Other: Group Exercise Program

Individual Exercise Training

Active Comparator group

Description:

Individual Exercise Program. The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al. and Sundstrup et al . During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session.

Treatment:

Other: Individual Exercise Program