Postural Garment Versus Exercises for Women With Cervical Pain

NCT03560492 | Completed

• 1 other identifier: UA001GRCSSS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Posture; Cervical Pain

Keywords

posture; cervical pain; exercise

Outcome Measures

Primary Outcomes (2)

• Change from baseline cervical Pain measured with a visual analog scale at 3 months

  Visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual subjects. It achieves a rapid (statistically measurable and reproducible) classification of symptom severity. A 100-mm long horizontal line with verbal descriptors is used to grade the amount of pain that a patient feels from no pain (left 0 mm) to an extreme amount of pain (right 100 mm).

  Pain is assessed pre-intervention (Day 0) and at Month 3 of follow-up.

• Change from baseline cervical Pain at 3 months (after the wash out period)

  Visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual subjects. It achieves a rapid (statistically measurable and reproducible) classification of symptom severity. A 100-mm long horizontal line with verbal descriptors is used to grade the amount of pain that a patient feels from no pain (left 0 mm) to an extreme amount of pain (right 100 mm).

  After the washout period, pain is assessed at baseline (Month 6) and after 3 months of intervention (Month 9)

Secondary Outcomes (12)

• Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )

  Posture is assessed pre-intervention (Day 0))

• Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )

  Posture is assessed at Month 3 of follow-up.

• Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )

  Posture measurement is repeated after the 3-month washout period (Month 6)

• Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )

  Posture is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention

• Neck Disability Index

  Neck disability is assessed pre-intervention (Day 0)

Other Outcomes (4)

• Garment comfort

  garment comfort is assessed at Month 1 when allocated to the garment group intervention.

• Garment comfort

  garment comfort is assessed at Month 3 when allocated to the garment group intervention.

• Assessment of global perceived effect of treatment

  Perceived effect of treatment is assessed at Month 3 of follow-up.

Study Arms (2)

Posture Plus Force

EXPERIMENTAL

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.

Device: Posture garment

Exercise

ACTIVE COMPARATOR

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.

Other: Exercises

Interventions

Exercises 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.

Exercise

Posture garment 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.

Posture Plus Force

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Andorra: lead

Study Sites (1)

Hospital N Sra de Meritxell - Rehabilitation Department

Les Escaldes, Spanish, AD700, Andorra

Location

Related Publications (1)

• 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.

  PMID: 32297876 DERIVED

MeSH Terms

Conditions

Neck Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Merce Avellanet, MD, PhD

  Universitat d'Andorra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Postural assessment is performed by a blinded investigator with a device for computerized measurement of surface curvature in the upright position (SpinalMouse®).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Department - Adjunct professor

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: June 18, 2018
• Study Start: April 20, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 30, 2021
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

AN (1)