NCT03560492

Postural Garment Versus Exercises for Women With Cervical Pain

A Comparative Study of Postural Garment Versus Exercises for Women With Non-specific Cervical Pain: a Randomised Crossover Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Andorra · Academic / Other
• Sex: Female
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aim to compare a new postural garment (Posture Plus Force ®) versus exercises in women with non specific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work related musculoskeletal disorders.

Detailed description

OBJECTIVE: To investigate the effects of a postural garment versus exercises in nurses with non-specific cervical pain. DESIGN: Randomized cross over clinical trial with a 3 months sequence treatment and a 3 months washout period.. PARTICIPANTS: Nurses and allied health professionals with cervical pain aged 21 to 55 years. INTERVENTIONS: Participants are allocated at random to receive interventions in two groups: * P+ : a postural garment (Posture Plus Force - FGP srl ® - Italy) to be worn from 2 to 4 hours per day, during 90 days. * Ex: five physiotherapy sessions to learn stretching and strengthening exercises (20 minutes) with instructions to continue at home on a daily basis for 90 days. The subjects in each group will be cross over after three months of wash out period. MAIN OUTCOME MEASURES: The primary outcomes are postural control and pain intensity. Pictures on sagittal and frontal plane as well as measurements of static posturography with a scan (SpinalMouse ®) are conducted at T0 (pre-intervention), T1 immediately after garment fitting for P+ group and after the 5th session for Ex group, T30, T60 and T90 at day 30, day 60 and day 90 of follow-up. Pain is measured by visual analogue scale (VAS) on the same assessment days. STATISTICAL ANALYSIS: Statistical analysis is conducted following intention-to-treat principles, and the treatment effects calculated using linear mixed models.

Conditions

• Posture
• Cervical Pain

Interventions

Type	Name	Description
OTHER	Exercises	5 sessions of exercises of 20 minutes each. Participants have to do a set of cervical, dorsal and abdominal stretching and strengthening exercises. Participants receive instructions to continue at home on a daily basis for 3 months and record compliance in a logbook.
DEVICE	Posture garment	Participants are provided with the appropriate size of a posture garment which includes thoracic and abdominal tensional bands. They are instructed to wear it 2 to 4 h per day for a 3 month period and record compliance in a logbook daily.

Timeline

• Start date: 2017-04-20
• Primary completion: 2019-01-01
• Completion: 2021-01-30
• First posted: 2018-06-18
• Last updated: 2021-02-08

Locations

1 site across 1 country: Andorra