Clinical trial NCT03560492: Postural Garment Versus Exercises for Women With Cervical Pain
Official title: A Comparative Study of Postural Garment Versus Exercises for Women With Non-specific Cervical Pain: a Randomised Crossover Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posture
Cervical Pain
Keywords: posture
cervical pain
exercise
Lead sponsor: University of Andorra
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants are randomised to receive one intervention during the initial 3 month phase of the study and receive the other intervention during the second 3 month phase of the study, after a wash out 3 month period.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline cervical Pain measured with a visual analog scale at 3 months
timeFrame: Pain is assessed pre-intervention (Day 0) and at Month 3 of follow-up.
measure: Change from baseline cervical Pain at 3 months (after the wash out period)
timeFrame: After the washout period, pain is assessed at baseline (Month 6) and after 3 months of intervention (Month 9)
Secondary outcomes:
measure: Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )
timeFrame: Posture is assessed pre-intervention (Day 0))
measure: Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )
timeFrame: Posture is assessed at Month 3 of follow-up.
measure: Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )
timeFrame: Posture measurement is repeated after the 3-month washout period (Month 6)
measure: Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )
timeFrame: Posture is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
measure: Neck Disability Index
timeFrame: Neck disability is assessed pre-intervention (Day 0)
measure: Neck Disability Index
timeFrame: Neck disability is assessed at Month 3 of follow-up.
measure: Neck Disability Index
timeFrame: Neck disability is repeated after the 3-month washout period (Month 6)
measure: Neck Disability Index
timeFrame: Neck disability is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
measure: Pain Catastrophizing Scale
timeFrame: Assessed pre-intervention (Day 0)
measure: Pain Catastrophizing Scale
timeFrame: Assessed at Month 3 of follow-up.
measure: Pain Catastrophizing Scale
timeFrame: Pain Catastrophizing scale is repeated after the 3-month washout period (Month 6)
measure: Pain Catastrophizing Scale
timeFrame: Catastrophizing is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
Other outcomes:
measure: Garment comfort
timeFrame: garment comfort is assessed at Month 1 when allocated to the garment group intervention.
measure: Garment comfort
timeFrame: garment comfort is assessed at Month 3 when allocated to the garment group intervention.
measure: Assessment of global perceived effect of treatment
timeFrame: Perceived effect of treatment is assessed at Month 3 of follow-up.
measure: Assessment of global perceived effect of treatment
timeFrame: Perceived effect of treatment is assessed at Month 9 (end of study)
Locations:
city: Escaldes-engordany
country: Andorra
facility: Hospital N Sra de Meritxell - Rehabilitation Department
state: Spanish
Study officials:
affiliation: Universitat d'Andorra
name: Merce Avellanet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.