Postural Garment Versus Exercises for Women With Cervical Pain

Cervical Pain Clinical Trial

Official title:

A Comparative Study of Postural Garment Versus Exercises for Women With Non-specific Cervical Pain: a Randomised Crossover Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560492
• Other study ID #: UA001GRCSSS
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: February 2021
• Source: University of Andorra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 30, 2021
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Pain
• Neck Pain
• Posture

Intervention

Other:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Andorra	Hospital N Sra de Meritxell - Rehabilitation Department	Escaldes-engordany	Spanish

Sponsors (1)

Lead Sponsor	Collaborator
University of Andorra

Country where clinical trial is conducted

Andorra, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Garment comfort	Garment comfort is evaluated with a 5-point Likert scale with the following anchors • 1 - Very dissatisfied • 2 - dissatisfied • 3 - unsure • 4 - satisfied • 5 - Very satisfied	garment comfort is assessed at Month 1 when allocated to the garment group intervention.
Other	Garment comfort	Garment comfort is evaluated with a 5-point Likert scale with the following anchors • 1 - Very dissatisfied • 2 - dissatisfied • 3 - unsure • 4 - satisfied • 5 - Very satisfied	garment comfort is assessed at Month 3 when allocated to the garment group intervention.
Other	Assessment of global perceived effect of treatment	Assessment of global perceived effect of treatment is performed with a Visual Analog Scale . Visual analogue scale is a psychometric measuring instrument designed to document perceived effect of the treatment in individual subjects. A 100-mm long horizontal line with verbal descriptors is used to grade the perceived effect that a patient feels from no improvement (left 0 mm) to an great improvement (right 100 mm).	Perceived effect of treatment is assessed at Month 3 of follow-up.
Other	Assessment of global perceived effect of treatment	Assessment of global perceived effect of treatment is performed with a Visual Analog Scale . Visual analogue scale is a psychometric measuring instrument designed to document perceived effect of the treatment in individual subjects. A 100-mm long horizontal line with verbal descriptors is used to grade the perceived effect that a patient feels from no improvement (left 0 mm) to an great improvement (right 100 mm).	Perceived effect of treatment is assessed at Month 9 (end of study)
Primary	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.
Primary	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	Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )	SpinalMouse ® is a device that, combined with a computer program, assesses the curvatures of the spine without applying radiation. The device is guided manually on the skin along the spinous process apophysis from C7 to S3. The measuring head follows their contour in the sagittal plane and records clinically relevant data. A software program using an algorithm uses this information to calculate the angle of kyphosis and angle of lordosis. Data obtained have been proved to be reliable and accurate	Posture is assessed pre-intervention (Day 0))
Secondary	Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )	SpinalMouse ® is a device that, combined with a computer program, assesses the curvatures of the spine without applying radiation. The device is guided manually on the skin along the spinous process apophysis from C7 to S3. The measuring head follows their contour in the sagittal plane and records clinically relevant data. A software program using an algorithm uses this information to calculate the angle of kyphosis and angle of lordosis. Data obtained have been proved to be reliable and accurate	Posture is assessed at Month 3 of follow-up.
Secondary	Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )	SpinalMouse ® is a device that, combined with a computer program, assesses the curvatures of the spine without applying radiation. The device is guided manually on the skin along the spinous process apophysis from C7 to S3. The measuring head follows their contour in the sagittal plane and records clinically relevant data. A software program using an algorithm uses this information to calculate the angle of kyphosis and angle of lordosis. Data obtained have been proved to be reliable and accurate	Posture measurement is repeated after the 3-month washout period (Month 6)
Secondary	Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )	SpinalMouse ® is a device that, combined with a computer program, assesses the curvatures of the spine without applying radiation. The device is guided manually on the skin along the spinous process apophysis from C7 to S3. The measuring head follows their contour in the sagittal plane and records clinically relevant data. A software program using an algorithm uses this information to calculate the angle of kyphosis and angle of lordosis. Data obtained have been proved to be reliable and accurate	Posture is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
Secondary	Neck Disability Index	Cervical pain-related disability will be assessed with the validated Spanish version of Neck Disability Index. The Neck Disability Index is a ten-item questionnaire based on the Oswestry Low Back Pain Index that assesses disability associated with neck pain and whiplash. There are four items that relate to subjective symptomatology (pain intensity, headache, concentration, sleeping) and six items that relate to activities of daily living (lifting, work, driving, recreation, personal care, reading). The questionnaire is self and administered requires only 5-10 minutes to complete. It is scored from 0 (no disability) to 50 (maximum disability). Each subject select from one of six potential responses for each item ranging from no disability (0) to total disability (5). The ten items are summed to gain the total score.	Neck disability is assessed pre-intervention (Day 0)
Secondary	Neck Disability Index	Cervical pain-related disability will be assessed with the validated Spanish version of Neck Disability Index. The Neck Disability Index is a ten-item questionnaire based on the Oswestry Low Back Pain Index that assesses disability associated with neck pain and whiplash. There are four items that relate to subjective symptomatology (pain intensity, headache, concentration, sleeping) and six items that relate to activities of daily living (lifting, work, driving, recreation, personal care, reading). The questionnaire is self and administered requires only 5-10 minutes to complete. It is scored from 0 (no disability) to 50 (maximum disability). Each subject select from one of six potential responses for each item ranging from no disability (0) to total disability (5). The ten items are summed to gain the total score.	Neck disability is assessed at Month 3 of follow-up.
Secondary	Neck Disability Index	Cervical pain-related disability will be assessed with the validated Spanish version of Neck Disability Index. The Neck Disability Index is a ten-item questionnaire based on the Oswestry Low Back Pain Index that assesses disability associated with neck pain and whiplash. There are four items that relate to subjective symptomatology (pain intensity, headache, concentration, sleeping) and six items that relate to activities of daily living (lifting, work, driving, recreation, personal care, reading). The questionnaire is self and administered requires only 5-10 minutes to complete. It is scored from 0 (no disability) to 50 (maximum disability). Each subject select from one of six potential responses for each item ranging from no disability (0) to total disability (5). The ten items are summed to gain the total score.	Neck disability is repeated after the 3-month washout period (Month 6)
Secondary	Neck Disability Index	Cervical pain-related disability will be assessed with the validated Spanish version of Neck Disability Index. The Neck Disability Index is a ten-item questionnaire based on the Oswestry Low Back Pain Index that assesses disability associated with neck pain and whiplash. There are four items that relate to subjective symptomatology (pain intensity, headache, concentration, sleeping) and six items that relate to activities of daily living (lifting, work, driving, recreation, personal care, reading). The questionnaire is self and administered requires only 5-10 minutes to complete. It is scored from 0 (no disability) to 50 (maximum disability). Each subject select from one of six potential responses for each item ranging from no disability (0) to total disability (5). The ten items are summed to gain the total score.	Neck disability is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
Secondary	Pain Catastrophizing Scale	In order to assess the catastrophizing dimension related to pain, the Pain Catastrophizing Scale is used. It is a 13-item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time) that yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score ranges from 0 to 52. It is a self-report measurement tool that provided a valid index of catastrophizing in clinical populations.	Assessed pre-intervention (Day 0)
Secondary	Pain Catastrophizing Scale	In order to assess the catastrophizing dimension related to pain, the Pain Catastrophizing Scale is used. It is a 13-item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time) that yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score ranges from 0 to 52. It is a self-report measurement tool that provided a valid index of catastrophizing in clinical populations.	Assessed at Month 3 of follow-up.
Secondary	Pain Catastrophizing Scale	In order to assess the catastrophizing dimension related to pain, the Pain Catastrophizing Scale is used. It is a 13-item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time) that yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score ranges from 0 to 52. It is a self-report measurement tool that provided a valid index of catastrophizing in clinical populations.	Pain Catastrophizing scale is repeated after the 3-month washout period (Month 6)
Secondary	Pain Catastrophizing Scale	In order to assess the catastrophizing dimension related to pain, the Pain Catastrophizing Scale is used. It is a 13-item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time) that yields a total score and three subscale scores assessing rumination, magnification and helplessness. Total score ranges from 0 to 52. It is a self-report measurement tool that provided a valid index of catastrophizing in clinical populations.	Catastrophizing is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention