PostureNCT03560492
Postural Garment Versus Exercises for Women With Cervical Pain
A study testing Exercises and Posture garment in people with Posture and Cervical Pain, run by University of Andorra at 1 site in Andorra.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posture, Cervical Pain
- What is being tested?
- Exercises and Posture garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAndorra
- Study dates
- 20 Apr 2017to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Andorra1 site
Hospital N Sra de Meritxell - Rehabilitation Department
Les Escaldes, Spanish, AD700
About this study
Official title: A Comparative Study of Postural Garment Versus Exercises for Women With Non-specific Cervical Pain: a Randomised Crossover Trial.
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.
Read the 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.
- Conditions
- Posture, Cervical Pain
- Being tested
- Exercises, Posture garment
- Keywords
- posture, cervical pain, exercise
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
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.
Posture garmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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® )
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Catastrophizing is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start20 Apr 2017
- Primary completion1 Jan 2019
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Andorra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merce AVELLANET, University of Andorra
- Investigators
- Merce Avellanet, MD, PhD, Principal investigator, Universitat d'Andorra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560492
- Sponsor's protocol ID
- UA001GRCSSS
- Status last verified
- Feb 2021
- First submitted
- 3 May 2018
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32297876
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Postural Garment Versus Exercises for Women With Non-specific Cervical Pain: a Randomised Crossover Trial.
- ClinicalTrials.gov ID
- NCT03560492
- Acronym / sponsor ID
- UA001GRCSSS
- Conditions
- Posture, Cervical Pain
- Keywords
- posture, cervical pain, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of AndorraUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Posture Plus Force | Experimental | Device: Posture garmentParticipants 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. |
| Exercise | Active comparator | Other: ExercisesA 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. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercises5 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. | Other | Exercise |
| Posture garmentParticipants 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. | Device | Posture Plus Force |
Primary outcome
Change from baseline cervical Pain measured with a visual analog scale at 3 months
Time frame: Pain is assessed pre-intervention (Day 0) and at Month 3 of follow-up.
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).
Change from baseline cervical Pain at 3 months (after the wash out period)
Time frame: After the washout period, pain is assessed at baseline (Month 6) and after 3 months of intervention (Month 9)
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).
12 secondary outcomes
Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )
Time frame: Posture is assessed pre-intervention (Day 0))
Posture measured by angle of Kyphosis and angle of lordosis with a computerized device (SpinalMouse® )
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® )
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® )
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
Time frame: Neck disability is assessed pre-intervention (Day 0)
Neck Disability Index
Time frame: Neck disability is assessed at Month 3 of follow-up.
Neck Disability Index
Time frame: Neck disability is repeated after the 3-month washout period (Month 6)
Neck Disability Index
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
Time frame: Assessed pre-intervention (Day 0)
Pain Catastrophizing Scale
Time frame: Assessed at Month 3 of follow-up.
Pain Catastrophizing Scale
Time frame: Pain Catastrophizing scale is repeated after the 3-month washout period (Month 6)
Pain Catastrophizing Scale
Time frame: Catastrophizing is assessed at Month 9 (end of study) after the washout period and the cross over 3 months intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Derived from this study: PubMed 32297876Avellanet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merce Avellanet, MD, PhD principal investigator
Universitat d'Andorra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises and Posture garment in people with Posture and Cervical Pain, run by University of Andorra at 1 site in Andorra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Andorra. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cervical Pain measured with a visual analog scale at 3 months (time frame: Pain is assessed pre-intervention (Day 0) and at Month 3 of follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.