Shoulder Impingement SyndromePRTBNCT01314196
Progressive Resistance Training of the Biceps in Subacromial Impingement Syndrome
A study testing therapeutic exercises and biceps resistance training and therapeutic exercises in people with Shoulder Impingement Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the influence of progressive resistance training of the biceps in shoulder rehabilitation in patients with subacromial impingement syndrome (SIS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- therapeutic exercises and biceps resistance training and therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2008to Dec 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a clinical diagnosis of injury to one or more muscles of the rotator cuff;
- pain for three months or more, and pain between three and eight, according to visual analog scale (VAS);
- Hawkins and Neer test positive;
- aged between 18 and 65
Who cannot join
- fractures of the upper phase of consolidation;
- patients with total rupture of the long head of the biceps due to the impossibility of getting the muscle resistance training;
- patients undergoing surgical procedures for shoulder in the three months preceding the study;
- associated rheumatic diseases because they may interfere in the evaluation of patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Resistance Training Biceps as an Adjunct to Rehabilitation of the Shoulder in Subacromial Impingement Syndrome (SIS)
The aim of this study was to evaluate the influence of progressive resistance training of the biceps in shoulder rehabilitation in patients with subacromial impingement syndrome (SIS).
Method: a randomized controlled clinical trial, with analysis intention-to-treat, approved by the Ethics and Research (1019/08), containing sixty patients of both sexes, SIS, evaluated at the initial time (T0), with 45 days (T45) and 90 days of treatment (T90). We analyzed the pain at rest (VAS), range of shoulder movement, strength, function by The Disabilities of Arm, Shoulder and Hand (DASH) and quality of life by Short Form-36 (SF-36) and Western Ontario Rotator Cuff Index (WORC). They recommended the use of NSAIDs and analgesics in the presence of pain exacerbated, every eight hours. Study groups will perform therapeutic exercises for the shoulder and scapula stabilizers. In the experimental group associate progressive resistance training of the biceps.
Read the detailed description
Sixty patients in the Physical Therapy Clinic at the University of Health Sciences of Alagoas, of both sexes with a clinical diagnosis of SIS, according to the criteria of Neer. Included will be those with a diagnosis of injury to one or more rotator cuff tendons, with pain for three months or more, ranging from 3 to 8, based on visual analogic scale(VAS) ranging from 0 to 10. Hawkins' test and Neer positive and aged between 18 and 65. The presence of total rupture of the long head of biceps, and associated rheumatic shoulder surgery represented exclusion criteria. After approval by the IRB (1019/08) were prepared sealed envelopes, to maintain the secrecy of allocation, and the patients were divided into control and experimental group and evaluated by a blind assessor, at the initial time (T0), after 45 days of treatment (T45) and 90 days of treatment (T90). The shoulder will be assessed in the degree of active motion for flexion, extension, medial and lateral rotation and abduction, with the patient in standing position using manual goniometer. To determine the movement of flexion and extension, the upper limb was positioned in the sagittal plane, goniometer along the mid-axillary line of the trunk and the axle in the humeral head. The movable arm of the goniometer was placed over the body surface of the humerus toward the lateral epicondyle. Abduction to the fixed arm of the goniometer was positioned over the posterior axillary line of the trunk, aligned with the blade and the moving arm was placed on the posterior surface of the arm along the longitudinal axis of the humerus. The medial and lateral rotation was accomplished by positioning the shoulder in abduction of 90 degrees, the axle of the goniometer positioned on the olecranon and the movable arm along the axis of the forearm.
The strength of manual pressure was assessed using the hydraulic dynamometer, manufactured in Korea. The instrument is graduated in two scales - kilogram force (Maximum 90 pounds), form-fitting and catcher with five adjustment positions to accommodate any size hand during the evaluation. During the strength assessment, the upper limb was positioned at rest beside the body with elbow flexed 90 degrees, forearm and wrist in neutral position.
Pain assessment will be conducted at rest, using VAS ranging from 0 (no pain) to 10 cm (intolerable pain). The Disabilities of The Arm, Shoulder and Hand (DASH) questionnaire was used for the evaluation of impairment and physical symptoms of upper limbs. It consists of 30 mandatory items related to function and symptoms (DASH 1) and two optional areas, divided into four issues for work activities (DASH 2) and 4 questions for activities of daily living (DASH 3). The Western Ontario Rotator Cuff Index (WORC) and Short- form health survey (SF-36) were the tools used to evaluate the quality of life. The WORC is specific to patients suffering from rotator cuff injury with five domains: physical symptoms (SF), sports and recreation (ER), work (T), state of vitality (EV) and emotion (E). The WORC scores can be set by calculation or by the general analysis of independent domains.
The treatment plan will be held for 3 months, twice a week throughout the sample, through the practice of therapeutic exercises for the shoulder and scapula stabilizers using bat without charge, training and isometric exercises commuting to the cuff muscles, without subacromial generate impaction. In the experimental group, we associate the progressive resistance training of the biceps. The progression of resistance training biceps, based on calculations of maximum resistance (MR), being conducted in three sets of 10 repetitions with 50% of MRI in the first series of training and 75% of MRI in the second series, 2 minutes, between each. In the presence of pain greater than or equal to seven, based on the VAS, patients were instructed in the use of paracetamol 750mg every six hours and diclofenac sodium 50mg every eight hours.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- therapeutic exercises, biceps resistance training and therapeutic exercises
- Keywords
- biceps, resistance training, rehabilitation, impact syndrome
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exercisesOther
therapeutic exercises for the shoulder and scapula stabilizers using bat without charge, training and isometric exercises commuting to the cuff muscles, without producing subacromial impaction.
biceps resistance training and therapeutic exercisesOther
Also called progressive resistance training
The biceps resistance training based on calculations of maximum resistance (MR), being conduct in three series 10 reps with 50% of MR in the first series of training and 75% of MR in the second series, with 2 minutes between each and therapeutic exercises for the shoulder and scapula stabilizers.
| Study group | Role | What they receive |
|---|---|---|
| therapeutic exercises | Active comparator | therapeutic exercises for the shoulder and scapula stabilizers Receives: Other: therapeutic exercises |
| progressive resistance training biceps | Experimental | therapeutic exercises for the shoulder and scapula stabilizers and biceps resistance training. Receives: Other: biceps resistance training and therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain at rest and quality of life
Pain assessment will be conducted at rest, using VAS ranging from 0 (no pain) to 10 cm (unbearable pain). The Westein Ontario Rotator Cuff Index (WORC) and Short form-36(SF-36) were the instruments used to assess the quality of life.
Measured: initial time, 45 days and 90 days of treatment
Secondary outcomes (1)
Evaluation range of motion,strength and physical symptoms of the shoulder
The range of motion the shoulder will be assessed by goniometry for flexion, extension, medial and lateral rotation and abduction. The strength of manual pressure was assessed using the hydraulic dynamometer, Jamar type, manufactured by Saehan Corporation in Korea. O Disabilities Of The Arm, Shoulder and Hand (DASH), was intended for assessment of physical symptoms and disorders of the upper limbs.
Measured: initial time, 45 days and 90 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startDec 2008
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- ANA C COÊLHO, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314196
- Sponsor's protocol ID
- UNCISAL/1019
- Acronym
- PRTB
- Status last verified
- Dec 2010
- First submitted
- 9 Mar 2011
- Last updated
- 14 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Resistance Training Biceps as an Adjunct to Rehabilitation of the Shoulder in Subacromial Impingement Syndrome (SIS)
- ClinicalTrials.gov ID
- NCT01314196
- Acronym / sponsor ID
- PRTB / UNCISAL/1019
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- biceps, resistance training, rehabilitation, impact syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Mar 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 aim of this study was to evaluate the influence of progressive resistance training of the biceps in shoulder rehabilitation in patients with subacromial impingement syndrome (SIS).
Method: a randomized controlled clinical trial, with analysis intention-to-treat, approved by the Ethics and Research (1019/08), containing sixty patients of both sexes, SIS, evaluated at the initial time (T0), with 45 days (T45) and 90 days of treatment (T90). We analyzed the pain at rest (VAS), range of shoulder movement, strength, function by The Disabilities of Arm, Shoulder and Hand (DASH) and quality of life by Short Form-36 (SF-36) and Western Ontario Rotator Cuff Index (WORC). They recommended the use of NSAIDs and analgesics in the presence of pain exacerbated, every eight hours. Study groups will perform therapeutic exercises for the shoulder and scapula stabilizers. In the experimental group associate progressive resistance training of the biceps.
Detailed description
Sixty patients in the Physical Therapy Clinic at the University of Health Sciences of Alagoas, of both sexes with a clinical diagnosis of SIS, according to the criteria of Neer. Included will be those with a diagnosis of injury to one or more rotator cuff tendons, with pain for three months or more, ranging from 3 to 8, based on visual analogic scale(VAS) ranging from 0 to 10. Hawkins' test and Neer positive and aged between 18 and 65. The presence of total rupture of the long head of biceps, and associated rheumatic shoulder surgery represented exclusion criteria. After approval by the IRB (1019/08) were prepared sealed envelopes, to maintain the secrecy of allocation, and the patients were divided into control and experimental group and evaluated by a blind assessor, at the initial time (T0), after 45 days of treatment (T45) and 90 days of treatment (T90). The shoulder will be assessed in the degree of active motion for flexion, extension, medial and lateral rotation and abduction, with the patient in standing position using manual goniometer. To determine the movement of flexion and extension, the upper limb was positioned in the sagittal plane, goniometer along the mid-axillary line of the trunk and the axle in the humeral head. The movable arm of the goniometer was placed over the body surface of the humerus toward the lateral epicondyle. Abduction to the fixed arm of the goniometer was positioned over the posterior axillary line of the trunk, aligned with the blade and the moving arm was placed on the posterior surface of the arm along the longitudinal axis of the humerus. The medial and lateral rotation was accomplished by positioning the shoulder in abduction of 90 degrees, the axle of the goniometer positioned on the olecranon and the movable arm along the axis of the forearm.
The strength of manual pressure was assessed using the hydraulic dynamometer, manufactured in Korea. The instrument is graduated in two scales - kilogram force (Maximum 90 pounds), form-fitting and catcher with five adjustment positions to accommodate any size hand during the evaluation. During the strength assessment, the upper limb was positioned at rest beside the body with elbow flexed 90 degrees, forearm and wrist in neutral position.
Pain assessment will be conducted at rest, using VAS ranging from 0 (no pain) to 10 cm (intolerable pain). The Disabilities of The Arm, Shoulder and Hand (DASH) questionnaire was used for the evaluation of impairment and physical symptoms of upper limbs. It consists of 30 mandatory items related to function and symptoms (DASH 1) and two optional areas, divided into four issues for work activities (DASH 2) and 4 questions for activities of daily living (DASH 3). The Western Ontario Rotator Cuff Index (WORC) and Short- form health survey (SF-36) were the tools used to evaluate the quality of life. The WORC is specific to patients suffering from rotator cuff injury with five domains: physical symptoms (SF), sports and recreation (ER), work (T), state of vitality (EV) and emotion (E). The WORC scores can be set by calculation or by the general analysis of independent domains.
The treatment plan will be held for 3 months, twice a week throughout the sample, through the practice of therapeutic exercises for the shoulder and scapula stabilizers using bat without charge, training and isometric exercises commuting to the cuff muscles, without subacromial generate impaction. In the experimental group, we associate the progressive resistance training of the biceps. The progression of resistance training biceps, based on calculations of maximum resistance (MR), being conducted in three sets of 10 repetitions with 50% of MRI in the first series of training and 75% of MRI in the second series, 2 minutes, between each. In the presence of pain greater than or equal to seven, based on the VAS, patients were instructed in the use of paracetamol 750mg every six hours and diclofenac sodium 50mg every eight hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapeutic exercises | Active comparator | Other: therapeutic exercisestherapeutic exercises for the shoulder and scapula stabilizers |
| progressive resistance training biceps | Experimental | Other: biceps resistance training and therapeutic exercisestherapeutic exercises for the shoulder and scapula stabilizers and biceps resistance training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a clinical diagnosis of injury to one or more muscles of the rotator cuff;
- pain for three months or more, and pain between three and eight, according to visual analog scale (VAS);
- Hawkins and Neer test positive;
- aged between 18 and 65
Key exclusion criteria (4 listed)
- fractures of the upper phase of consolidation;
- patients with total rupture of the long head of the biceps due to the impossibility of getting the muscle resistance training;
- patients undergoing surgical procedures for shoulder in the three months preceding the study;
- associated rheumatic diseases because they may interfere in the evaluation of patients.
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 |
|---|---|---|
| therapeutic exercisestherapeutic exercises for the shoulder and scapula stabilizers using bat without charge, training and isometric exercises commuting to the cuff muscles, without producing subacromial impaction. | Other | therapeutic exercises |
| biceps resistance training and therapeutic exercisesAlso: progressive resistance trainingThe biceps resistance training based on calculations of maximum resistance (MR), being conduct in three series 10 reps with 50% of MR in the first series of training and 75% of MR in the second series, with 2 minutes between each and therapeutic exercises for the shoulder and scapula stabilizers. | Other | progressive resistance training biceps |
Primary outcome
Evaluation of pain at rest and quality of life
Time frame: initial time, 45 days and 90 days of treatment
Pain assessment will be conducted at rest, using VAS ranging from 0 (no pain) to 10 cm (unbearable pain). The Westein Ontario Rotator Cuff Index (WORC) and Short form-36(SF-36) were the instruments used to assess the quality of life.
1 secondary outcome
Evaluation range of motion,strength and physical symptoms of the shoulder
Time frame: initial time, 45 days and 90 days of treatment
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 14 Mar 2011.
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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.
ANA C COÊLHO principal investigator
Federal University of São 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 therapeutic exercises and biceps resistance training and therapeutic exercises in people with Shoulder Impingement Syndrome, run by Federal University of São 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 4 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 14 Mar 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?
Evaluation of pain at rest and quality of life (time frame: initial time, 45 days and 90 days of treatment). 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 14 Mar 2011.