Scapular DyskinesisPhase 1NCT01568840
Global Postural Reeducation and Segmental Exercises in Patients With Scapular Dyskinesis and Cervicalgia
A Phase 1 study testing Global Postural Reeducation Group and Segmental Exercises Group in people with Scapular Dyskinesis and Cervicalgia, run by Irmandade da Santa Casa de Misericordia de Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to assess the effectiveness of global postural reeducation relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scapular Dyskinesis, Cervicalgia
- What is being tested?
- Global Postural Reeducation Group and Segmental Exercises Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Feb 2011
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scapular Dyskinesis as per the SICK Scapula Rating Scale
- Chronic Cervicalgia (pain for at least three months)
Who cannot join
- Cervical Stenosis
- Myelopathy
- Prolapsed Inter-Vertebral Disk (as confirmed by magnetic resonance imaging),
- Winged Scapula due to lesions of the long thoracic nerve or spinal accessory nerve, (as documented by electromyography)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade da Santa Casa de Misericordia de Sao Paulo
São Paulo, São Paulo, 01221-010
About this study
Official title: Effectiveness of Global Postural Reeducation and Segmental Exercises on Function, Pain, and Quality of Life of Patients With Scapular Dyskinesis and Cervicalgia: A Randomized Clinical Study
The purpose of this study is to assess the effectiveness of global postural reeducation relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.
Read the detailed description
Purpose: To assess the effectiveness of global postural reeducation relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.
Methods: Participants with scapular dyskinesis and cervicalgia (n = 30) aged 18 to 65 years were randomly assigned to one of two groups: Global Postural Reeducation and Segmental Exercises(stretching and strengthening). Upper extremity was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Function of the neck was estimated using the Neck Disability Index (NDI). Pain severity was measured using a Visual Analogical Scale. Health-related quality of life (HRQoL) was assessed using the Short Form (SF)-12. Assessments were conducted at baseline and after 10 weekly sessions (60 minutes each). Significance level was established at 5%.
- Conditions
- Scapular Dyskinesis, Cervicalgia
- Being tested
- Global Postural Reeducation Group, Segmental Exercises Group
- Keywords
- Physical Therapy Modalities, Posture, Muscle Stretching Exercises, Dyskinesias, Neck pain
- Medical subject headings
- Neck Pain, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Postural Reeducation GroupOther
Also called Global Postural Reeducation, Stretching Exercises
Sessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in manual therapy maneuvers and global postural reeducation treatment.
Segmental Exercises GroupOther
Also called Segmental Exercises, Stretching and Strengthening Exercises
Sessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in segmental exercises (stretching and strengthening) treatment.
| Study group | Role | What they receive |
|---|---|---|
| Global Postural Reeducation Group | Experimental | Global Postural Reeducation Receives: Other: Global Postural Reeducation Group |
| Segmental Exercises Group | Active comparator | Segmental Exercises Receives: Other: Segmental Exercises Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function of the upper extremity
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was used to measure function of the upper extremity, where 0 corresponded to "no disability" and 100 corresponded to "most severe disability".
Measured: 10 weeks
Secondary outcomes (3)
Pain severity
The Visual Analogical Scale (VAS) was used to measure pain, where the left extremity corresponded to"no pain" and the right extremity, corresponded to"maximum pain".
Measured: 10 weeks
Health-related quality of life (HRQoL)
The HRQoL was assessed using the Short Form (SF)-12, the abbreviated version of the SF-36, whose score ranges from 0 to 100, and higher scores reflect better quality of life.
Measured: 10 weeks
Function of the neck
The Neck Disability Index (NDI) was used to measure fuction of the neck, whose score ranges from 0 to 50: disability (0-5); mild disability (5-14); moderate disability (15-24); severe disability (25-34) and totally disabled (35-50).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapular DyskinesisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cinthia Santos Miotto de Amorim, Irmandade da Santa Casa de Misericordia de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568840
- Sponsor's protocol ID
- 192/10
- Status last verified
- Mar 2012
- First submitted
- 26 Mar 2012
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Global Postural Reeducation and Segmental Exercises on Function, Pain, and Quality of Life of Patients With Scapular Dyskinesis and Cervicalgia: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01568840
- Acronym / sponsor ID
- 192/10
- Conditions
- Scapular Dyskinesis, Cervicalgia
- Keywords
- Physical Therapy Modalities, Posture, Muscle Stretching Exercises, Dyskinesias, Neck pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao PauloUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011
- First posted
- 2 Apr 2012 (estimated)
- 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.
The purpose of this study is to assess the effectiveness of global postural reeducation relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.
Detailed description
Purpose: To assess the effectiveness of global postural reeducation relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.
Methods: Participants with scapular dyskinesis and cervicalgia (n = 30) aged 18 to 65 years were randomly assigned to one of two groups: Global Postural Reeducation and Segmental Exercises(stretching and strengthening). Upper extremity was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Function of the neck was estimated using the Neck Disability Index (NDI). Pain severity was measured using a Visual Analogical Scale. Health-related quality of life (HRQoL) was assessed using the Short Form (SF)-12. Assessments were conducted at baseline and after 10 weekly sessions (60 minutes each). Significance level was established at 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global Postural Reeducation Group | Experimental | Other: Global Postural Reeducation GroupGlobal Postural Reeducation |
| Segmental Exercises Group | Active comparator | Other: Segmental Exercises GroupSegmental Exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scapular Dyskinesis as per the SICK Scapula Rating Scale
- Chronic Cervicalgia (pain for at least three months)
Key exclusion criteria (4 listed)
- Cervical Stenosis
- Myelopathy
- Prolapsed Inter-Vertebral Disk (as confirmed by magnetic resonance imaging),
- Winged Scapula due to lesions of the long thoracic nerve or spinal accessory nerve, (as documented by electromyography)
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 |
|---|---|---|
| Global Postural Reeducation GroupAlso: Global Postural Reeducation, Stretching ExercisesSessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in manual therapy maneuvers and global postural reeducation treatment. | Other | Global Postural Reeducation Group |
| Segmental Exercises GroupAlso: Segmental Exercises, Stretching and Strengthening ExercisesSessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in segmental exercises (stretching and strengthening) treatment. | Other | Segmental Exercises Group |
Primary outcome
Function of the upper extremity
Time frame: 10 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was used to measure function of the upper extremity, where 0 corresponded to "no disability" and 100 corresponded to "most severe disability".
3 secondary outcomes
Pain severity
Time frame: 10 weeks
Health-related quality of life (HRQoL)
Time frame: 10 weeks
Function of the neck
Time frame: 10 weeks
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 2 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Global Postural Reeducation Group and Segmental Exercises Group in people with Scapular Dyskinesis and Cervicalgia, run by Irmandade da Santa Casa de Misericordia de Sao Paulo at 1 site in Brazil.
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 2 inclusion and 4 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 2 Apr 2012. 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 Brazil. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Function of the upper extremity (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2012.