Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-02-24 @ 11:40 AM
Study NCT ID:
NCT03560492
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2018-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postural Garment Versus Exercises for Women With Cervical Pain
Sponsor:
University of Andorra
Organization:
Study Overview
Official Title:
A Comparative Study of Postural Garment Versus Exercises for Women With Non-specific Cervical Pain: a Randomised Crossover Trial.
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: