Postural Garment Versus Exercises for Women With Cervical Pain

NCT ID: NCT03560492

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2021-01-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Posture Plus Force

Participants are provided with the posture garment. They have to wear it 2 to 4 h per day for a 3 month period. Participants receive a logbook that should be filled every day.

Group Type: EXPERIMENTAL

Posture garment

Intervention Type: DEVICE

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.

Exercise

A physiotherapist teaches exercises to participants (5 sessions of 20 minutes each of stretching and strengthening exercises). Exercises are focused on cervical and dorsal areas, Participants receive instructions to continue at home on a daily basis for 3 months. Participants receive a logbook that should be filled every day.

Group Type: ACTIVE_COMPARATOR

Exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Nurses and health allied professionals females with cervical pain
• Voluntarily signed informed consent
• Able to wear the garment and to do exercises and follow up assessments

Exclusion Criteria

• Pregnancy
• Malignancy or other severe disease
• Cervical pain with significant extremity symptoms and/or neurological dysfunction (cervical radiculopathy and cervical spondylotic myelopathy)
• Unable to perform exercises
• Unwilling to do follow up assessments
• Psychiatric disorders

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Andorra

OTHER

Sponsor Role: lead

Responsible Party

Merce AVELLANET

Head of Rehabilitation Department - Adjunct professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merce Avellanet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat d'Andorra

Locations

Hospital N Sra de Meritxell - Rehabilitation Department

Les Escaldes, Spanish, Andorra

Countries

Andorra

References

Avellanet M, Boada-Pladellorens A, Perrot JC, Loro L, Rodrigo Cansado L, Monterde D, Romagosa J, Gea E. Comparative Study of Postural Garment Versus Exercises for Patients With Nonspecific Cervical Pain: Protocol for a Randomized Crossover Trial. JMIR Res Protoc. 2020 Apr 16;9(4):e14807. doi: 10.2196/14807.

Reference Type: DERIVED

PMID: 32297876 (View on PubMed)

Other Identifiers

UA001GRCSSS

Identifier Type: -

Identifier Source: org_study_id