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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01465932
Other study ID # uspombro01
Secondary ID
Status Completed
Phase N/A
First received October 25, 2011
Last updated November 4, 2011
Start date July 2010
Est. completion date August 2011

Study information

Verified date October 2011
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The program of stretching, strengthening and proprioception is more effective than stretching and strengthening program in nursing, with rotator cuff disorder, according to indicators of quality of life and job satisfaction.


Description:

The study will be conducted at the Rehabilitation Centre of the Hospital of the Medical School of Ribeirão Preto, University of São Paulo (USP-HCFMRP).

The study will be conducted with nursing staff (nurses, technicians and nursing assistants) HCFMRP-USP.

The sample will consist of nursing workers sent by request for referral to a medical diagnosis of rotator cuff disorder in the period May 2010 to August 2011.

There was no sample size calculation for this study because the number of subjects directly depends on the demand of patients referred to the Department of Physical Therapy Rehabilitation Center (CER) in the period of data collection. All patients who met the study inclusion criteria were invited to participate.

So, once met the inclusion criteria of the sample, the subjects were randomly allocated to Group 1 (control) or 2 (experimental).

Group 1 was formed by the subjects in the control group in which they were performed stretching exercises, cryotherapy and strengthening the shoulder.

Group 2 was formed by the subjects in the experimental group were performed in which stretching exercises, strengthening, and cryotherapy proprioceção shoulder.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date August 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- working as a nurse

- technician or nursing assistant in the hospital

- make medical diagnosis of disorder in the rotator cuff (impingement, injury or rupture of the cuff)

- does not make a medical diagnosis of cognitive impairment

- were receiving no another type of treatment for shoulder pain (eg medicines,acupuncture, massage)

- availability and interest in participating in therapy and accept to participate in the survey.

Exclusion Criteria:

- patients with pain that would prohibit their participation in the program with a medical diagnosis of cognitive impairment,

- associated with debilitating diseases,

- previous surgery of the shoulder,

- other specific conditions of the shoulder joint (adhesive capsulitis,

- degenerative osteoarthritis of the glenohumeral joint,

- tendon calcification) and do not accept to join the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
Control, no Proprioception
The period of data collection period was from June 2010 to August 2011. All subjects who met the inclusion criteria, were randomly allocated to group 1 (control) or group 2 (experimental). Both groups consisted of 12 physical therapy sessions, taking place 2 times a week for 6 weeks. After randomization, subjects were allocated to group 1 (control group) underwent cervical stretching exercises, strengthening the scapular muscles and rotator cuff and cryotherapy.
Experimental, Proprioceptive exercises
The period of data collection period was from June 2010 to August 2011. All subjects who met the inclusion criteria, were randomly allocated to group 1 (control) or group 2 (experimental). Both groups consisted of 12 physical therapy sessions, taking place 2 times a week for 6 weeks. After randomization, subjects were allocated to group 2 (experimental group) underwent cervical stretching exercises, strengthening the scapular muscles and rotator cuff exercises and cryotherapy as well as proprioceptive sensory-motor

Locations

Country Name City State
Brazil Hospital of Clinics, University of Medicine of Ribeirao Preto Ribeirao Preto Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Indicators of quality of life (WORC - Western Ontario Rotator Cuff The Index) The WORC was selected to be a reliable tool for measuring quality of life for patients with rotator cuff disorder,available in Portuguese and validated for Brazilian culture by Lopes et al (2008).
The WORC consists of 21 items and has five fields, and you can get the total for each domain separately. The domains are: physical symptoms, sports and recreation, work, lifestyle and emotions. The total score ranges from zero to 2100. Thus, zero implies no reduction in quality of life and the worst score is 2100.
This scale is applied one day before and one day after the application of physical therapy intervention programs Yes
Secondary Questionnaire used was the Job Satisfaction Scale - Occupational Stress Indicator (OSI). This scale allows for the measurement of satisfaction with 22 aspects of psychosocial work using Likert scales of six points, ranging from huge to enormous satisfaction dissatisfaction. Such a tool available in Portuguese was validated by Cooper, Sloan and Williams (1988).
The sum of these measures provides an indicator of job satisfaction given by a global score that ranges from 22 to 123 points. There's a cutoff point defined herein
This scale is applied one day before and one day after the application of physical therapy intervention programs Yes
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