Comparative Study of Postural Garment Versus Exercises for Patients With Nonspecific Cervical Pain: Protocol for a Randomized Crossover Trial.
cervical exercises
cervical pain
musculoskeletal disorder
postural garment
posture
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
16 Apr 2020
16 Apr 2020
Historique:
received:
29
05
2019
accepted:
14
01
2020
revised:
08
12
2019
entrez:
17
4
2020
pubmed:
17
4
2020
medline:
17
4
2020
Statut:
epublish
Résumé
There is a high prevalence of work-related musculoskeletal disorders among health care professionals. Posture is an essential point to be addressed for health care professionals with musculoskeletal disorders. Cervical pain can result from several conditions. Treatment should include posture modification and home exercise. This study aims to compare a new postural garment (Posture Plus Force; Medi, Bayreuth, Germany) with exercises for women with nonspecific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work-related musculoskeletal disorders. This randomized crossover clinical trial has a 3-month treatment sequence and a 3-month washout period. Participants will include nurses and allied health professionals 21 to 55 years of age with cervical pain. Participants are allocated at random to two intervention groups: a postural garment (Posture Plus Force) to be worn for 2 to 4 hours per day for 90 days (P+ group) and five physiotherapy sessions (20 minutes each) to learn stretching and strengthening exercises with instructions to continue at home on a daily basis for 90 days (Ex group). The participants in each group will crossover interventions after a 3-month washout period. The primary outcomes are postural control and pain intensity. A static posturography will be performed with a scan (SpinalMouse; Idiag AG, Fehraltorf, Switzerland). The visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual participants. The secondary outcomes are cervical pain-related disability, catastrophizing, the global perceived effect of treatment, and the evaluation of garment comfort. Physical activity is assessed with the International Physical Activity Questionnaire. Assessment of primary and secondary outcomes is performed at T0 (pre-intervention), T1 (immediately after garment fitting for P+ group), T30, T60, and T90. The same measurements are recorded after the washout period and during the second intervention following the same sequence. All patients are provided with a logbook for compliance recording, over the counter drug use, pain evaluation, and sick leave. Statistical analysis is conducted following intention-to-treat principles and the treatment effects calculated using linear mixed models. The study design has been approved by the Ethics Commission of Hospital N Sra de Meritxell, Andorra in March 2017. A total of 32 participants are already enrolled in the study. An extension of the study is planned in a Spanish university hospital to achieve a larger sample. Study results are expected to be published during 2020. The Postural garment is expected to improve cervical pain by enhancing posture. ClinicalTrials.gov NCT03560492; https://clinicaltrials.gov/ct2/show/NCT03560492. DERR1-10.2196/14807.
Sections du résumé
BACKGROUND
BACKGROUND
There is a high prevalence of work-related musculoskeletal disorders among health care professionals. Posture is an essential point to be addressed for health care professionals with musculoskeletal disorders. Cervical pain can result from several conditions. Treatment should include posture modification and home exercise.
OBJECTIVE
OBJECTIVE
This study aims to compare a new postural garment (Posture Plus Force; Medi, Bayreuth, Germany) with exercises for women with nonspecific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work-related musculoskeletal disorders.
METHODS
METHODS
This randomized crossover clinical trial has a 3-month treatment sequence and a 3-month washout period. Participants will include nurses and allied health professionals 21 to 55 years of age with cervical pain. Participants are allocated at random to two intervention groups: a postural garment (Posture Plus Force) to be worn for 2 to 4 hours per day for 90 days (P+ group) and five physiotherapy sessions (20 minutes each) to learn stretching and strengthening exercises with instructions to continue at home on a daily basis for 90 days (Ex group). The participants in each group will crossover interventions after a 3-month washout period. The primary outcomes are postural control and pain intensity. A static posturography will be performed with a scan (SpinalMouse; Idiag AG, Fehraltorf, Switzerland). The visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual participants. The secondary outcomes are cervical pain-related disability, catastrophizing, the global perceived effect of treatment, and the evaluation of garment comfort. Physical activity is assessed with the International Physical Activity Questionnaire. Assessment of primary and secondary outcomes is performed at T0 (pre-intervention), T1 (immediately after garment fitting for P+ group), T30, T60, and T90. The same measurements are recorded after the washout period and during the second intervention following the same sequence. All patients are provided with a logbook for compliance recording, over the counter drug use, pain evaluation, and sick leave. Statistical analysis is conducted following intention-to-treat principles and the treatment effects calculated using linear mixed models.
RESULTS
RESULTS
The study design has been approved by the Ethics Commission of Hospital N Sra de Meritxell, Andorra in March 2017. A total of 32 participants are already enrolled in the study. An extension of the study is planned in a Spanish university hospital to achieve a larger sample. Study results are expected to be published during 2020.
CONCLUSIONS
CONCLUSIONS
The Postural garment is expected to improve cervical pain by enhancing posture.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03560492; https://clinicaltrials.gov/ct2/show/NCT03560492.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/14807.
Identifiants
pubmed: 32297876
pii: v9i4e14807
doi: 10.2196/14807
pmc: PMC7193442
doi:
Banques de données
ClinicalTrials.gov
['NCT03560492']
Types de publication
Journal Article
Langues
eng
Pagination
e14807Informations de copyright
©Merce Avellanet, Anna Boada-Pladellorens, Jean-Claude Perrot, Laura Loro, Lidia Rodrigo Cansado, David Monterde, Josep Romagosa, Elvira Gea. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.04.2020.
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