An interventional study of Exercises and Posture garment in Posture and Cervical Pain, sponsored by University of Andorra. Completed at 1 site in Andorra. Open to female participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by University of Andorra · Not applicable, Interventional, and Treatment
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.
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:
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 70 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →University of Andorra is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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).
Time frame: 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).
Time frame: After the washout period, pain is assessed at baseline (Month 6) and after 3 months of intervention (Month 9)
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
Time frame: Posture is assessed pre-intervention (Day 0))
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
Time frame: Posture is assessed at Month 3 of follow-up.
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
Time frame: 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® )
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
Time frame: Posture is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
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.
Time frame: Neck disability is assessed pre-intervention (Day 0)
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.
Time frame: Neck disability is assessed at Month 3 of follow-up.
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.
Time frame: Neck disability is repeated after the 3-month washout period (Month 6)
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.
Time frame: Neck disability is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
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.
Time frame: Assessed pre-intervention (Day 0)
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.
Time frame: Assessed at Month 3 of follow-up.
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.
Time frame: Pain Catastrophizing scale is repeated after the 3-month washout period (Month 6)
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.
Time frame: Catastrophizing is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
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
Time frame: garment comfort is assessed at Month 1 when allocated to the garment group intervention.
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
Time frame: garment comfort is assessed at Month 3 when allocated to the garment group intervention.
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).
Time frame: Perceived effect of treatment is assessed at Month 3 of follow-up.
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).
Time frame: Perceived effect of treatment is assessed at Month 9 (end of study)
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