Shoulder Impingement SyndromeNCT01465932
Effectiveness of Physical Therapy Program to Treat Rotator Cuff Disorders Among Nursing Professionals
A study testing Experimental, Proprioceptive exercises in people with Shoulder Impingement Syndrome and Quality of Life, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Impingement Syndrome, Quality of Life, Satisfaction
- What is being tested?
- Experimental, Proprioceptive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Aug 2011
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital of Clinics, University of Medicine of Ribeirao Preto
Ribeirão Preto, São Paulo, 055
About this study
Official title: Evaluation of the Effectiveness of Physical Therapy Program to Treat Rotator Cuff Disorders Among Nursing Professionals According to Indicators of Quality of Life and Job Satisfaction
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.
Read the detailed 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.
- Conditions
- Shoulder Impingement Syndrome, Quality of Life, Satisfaction
- Being tested
- Control, no Proprioception, Experimental, Proprioceptive exercises
- Keywords
- Nursing staff, Physical Therapy (Specialty)
- Medical subject headings
- Shoulder Impingement Syndrome, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control, no ProprioceptionOther
Also called 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 exercisesOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| No proprioception | Active comparator | Nursing professionals to diagnose disorders of the rotator cuff previously randomly allocated in this group did stretching exercises of the muscles of the cervical spine and chest, strengthening the muscles of the rotator cuff and stabilizers of the scapula, in addition to cryotherapy reduction of pain. Receives: Other: Control, no Proprioception |
| Proprioceptive exercises | Experimental | Nursing professionals to diagnose disorders of the rotator cuff previously randomly allocated in this group did stretching exercises of the muscles of the cervical spine and chest, strengthening the muscles of the rotator cuff and stabilizers of the scapula, proprioception exercises to improve motor control, besides cryotherapy for reduction of pain. Receives: Other: Experimental, Proprioceptive exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This scale is applied one day before and one day after the application of physical therapy intervention programs
Secondary outcomes (1)
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
Measured: This scale is applied one day before and one day after the application of physical therapy intervention programs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionAug 2011
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 Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisandra Vanessa Martins, University of Sao Paulo
- Investigators
- Lisandra V. Martins, postgraduate, Principal investigator, University of Sao PauloMaria HP Marziale, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465932
- Sponsor's protocol ID
- uspombro01
- Status last verified
- Oct 2011
- First submitted
- 25 Oct 2011
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martins LV, Marziale MH. Assessment of proprioceptive exercises in the treatment of rotator cuff disorders in nursing professionals: a randomized controlled clinical trial. Rev Bras Fisioter. 2012 Nov-Dec;16(6):502-9. doi: 10.1590/s1413-35552012005000057. Epub 2012 Nov 2.
PubMed 23117648
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Physical Therapy Program to Treat Rotator Cuff Disorders Among Nursing Professionals According to Indicators of Quality of Life and Job Satisfaction
- ClinicalTrials.gov ID
- NCT01465932
- Acronym / sponsor ID
- uspombro01
- Conditions
- Shoulder Impingement Syndrome, Quality of Life, Satisfaction
- Keywords
- Nursing staff, Physical Therapy (Specialty)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Nov 2011 (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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No proprioception | Active comparator | Other: Control, no ProprioceptionNursing professionals to diagnose disorders of the rotator cuff previously randomly allocated in this group did stretching exercises of the muscles of the cervical spine and chest, strengthening the muscles of the rotator cuff and stabilizers of the scapula, in addition to cryotherapy reduction of pain. |
| Proprioceptive exercises | Experimental | Other: Experimental, Proprioceptive exercisesNursing professionals to diagnose disorders of the rotator cuff previously randomly allocated in this group did stretching exercises of the muscles of the cervical spine and chest, strengthening the muscles of the rotator cuff and stabilizers of the scapula, proprioception exercises to improve motor control, besides cryotherapy for reduction of pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Control, no ProprioceptionAlso: No proprioceptionThe 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. | Other | No proprioception |
| Experimental, Proprioceptive exercisesAlso: Proprioceptive exercisesThe 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 | Other | Proprioceptive exercises |
Primary outcome
Indicators of quality of life (WORC - Western Ontario Rotator Cuff The Index)
Time frame: This scale is applied one day before and one day after the application of physical therapy intervention programs
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.
1 secondary outcome
Questionnaire used was the Job Satisfaction Scale - Occupational Stress Indicator (OSI).
Time frame: This scale is applied one day before and one day after the application of physical therapy intervention programs
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 7 Nov 2011.
- Derived from this study: PubMed 23117648Martins LV, Marziale MH. Assessment of proprioceptive exercises in the treatment of rotator cuff disorders in nursing professionals: a randomized controlled clinical trial. Rev Bras Fisioter. 2012 Nov-Dec;16(6):502-9. doi: 10.1590/s1413-35552012005000057. Epub 2012 Nov 2.
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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.
Lisandra V. Martins, postgraduate principal investigator
University of Sao Paulo
Maria HP Marziale study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental, Proprioceptive exercises in people with Shoulder Impingement Syndrome and Quality of Life, run by University of 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 6 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 7 Nov 2011. 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.
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?
Indicators of quality of life (WORC - Western Ontario Rotator Cuff The Index) (time frame: This scale is applied one day before and one day after the application of physical therapy intervention programs). 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 NCT01465932, 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 7 Nov 2011.