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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01568840
Other study ID # 192/10
Secondary ID
Status Completed
Phase Phase 1
First received March 26, 2012
Last updated March 29, 2012
Start date July 2010
Est. completion date February 2011

Study information

Verified date March 2012
Source Irmandade da Santa Casa de Misericordia de Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical 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.


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%.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Scapular Dyskinesis as per the SICK Scapula Rating Scale

- Chronic Cervicalgia (pain for at least three months)

Exclusion Criteria:

- 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Global Postural Reeducation Group
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 Group
Sessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in segmental exercises (stretching and strengthening) treatment.

Locations

Country Name City State
Brazil Irmandade da Santa Casa de Misericordia de Sao Paulo Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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". 10 weeks Yes
Secondary 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". 10 weeks Yes
Secondary 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. 10 weeks Yes
Secondary 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). 10 weeks Yes
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