- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02982460
Effects of Isoinertial Training on Rotator Cuff Tendinopathy
The Effects of Isoinertial Training on Rotator Cuff Tendinopathy. A Randomized Controlled Double-blind Follow-up Trail. A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design and setting The design of the present study will be a randomized controlled single-blind trial with 2 follow-ups (one week and one month after intervention) that will be performed between January 2017 and March 2017 in one private physiotherapy clinic in Malaga, Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and one month after intervention (t3). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.
Recruitment Eligible participants who will be interested in the study will be asked to provide written informed consent to participate. Subsequently the patient-reported outcome measures will be completed to establish baseline pain, function, rotator cuff strength, scapular muscle activity, scapular muscle endurance and level of self-efficacy. After completion of the baseline measures, the participants will be randomly allocated to the isoinertial training plus eccentric or eccentric training groups. The measures of pain, function, rotator cuff strength, scapular muscle activity, scapular muscle endurance and self-efficacy will be repeated one week and one month after intervention. Anonymized age and gender will be collected for those participants who decline to take part in the study to assess the external validity of the recruited sample of participants. Participant data files will be stored in numerical order and in a secure and accessible place and manner. Participant files will be maintained in storage for a period of 3 years after completion of the study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18-35 years
- Willing and able to participate
- Primary complaint of shoulder pain
- No/minimal resting for shoulder pain
- Range of shoulder movement largely preserved
- Two out of three positive impingement tests: empty-can test, Hawkins-Kennedy test, modified Neer test
- Pain on isometric rotator cuff testing, usually abduction or lateral rotation.
Exclusion Criteria:
- Subjective feeling of instability and positive apprehension sign
- Positive scapular assistance and/or resistance test
- Partial or full ruptures of the rotator cuff
- Calcifications greater than 4 mm
- (Acromion type III (per Bigliani criteria)
- Bursitis
- History of shoulder fracture and/or shoulder surgery
- Glenohumeral disorders (inflammatory arthritis, osteoarthritis, osteonecrosis, cuff arthropathy, septic arthritis, adhesive capsulitis, glenohumeral instability); (viii) Regional disorders (cervical radiculopathy, brachial neuritis, nerve entrapment syndrome, sternoclavicular arthritis, reflex sympathetic dystrophy, and neoplasms)
- Systemic diseases
- Corticosteroid injection 3 months prior to the study treatment and within 1 months prior to the study treatment on other body parts.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isoinertial + eccentric exercise
The isoinertial training will be based on 4 sets of 8 maximal repetitions using a YoYo-Squat (YoYo Technology AB, Stockholm, Sweden).
This exercise device use the inertia of a spinning flywheel (moment inertia = 0.11 kg m-2), offering resistance during coupled concentric and eccentric actions, and allows for high demanding to rotator cuff exercises while offering the possibility to perform with an eccentric overload.Two initial repetitions in any set were aimed at accelerating the flywheel, before executing the subsequent 8 actions at maximal effort.
Eccentric exercise will based on a set of 4 exercise implicating abduction, lateral rotation, extension and flexion of the shoulder.
|
A session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles.
|
Active Comparator: Eccentric exercise
Eccentric exercise will based on a set of 4 exercise implicating abduction, lateral rotation, extension and flexion of the shoulder.
Participants will attend three appointments per week over three weeks.
They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment.
|
A session of eccentric exercise covers the strength of scapular muscles.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Change from Baseline function at 1 month"
Time Frame: 1 month
|
This outcome will be measured with the shoulder pain and disability index (SPADI)
|
1 month
|
"Change from Baseline pain at 1 month"
Time Frame: 1 month
|
This outcome will be measured with the shoulder pain and disability index (SPADI)
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Change from Baseline rotator cuff strength at 1 months"
Time Frame: 1 month
|
The handheld dynamometer (HHD) (MicroFET 2, Hoggan Health Industries Inc., Biometrics, The Netherlands) was used to measure the following shoulder muscles strength: supraspinous, infraspinatus, subscapular, and teres minor.
|
1 month
|
"Change from Baseline scapular muscle activity at 1 months"
Time Frame: 1 month
|
Surface electromyography (EMG; BTS FREEEMG 300, BTS S. p. A., Milan, Italy) was used to measure muscle activity.
We attached an electrode to the supraspinous, infraspinatus, subscapular, and teres minor.
|
1 month
|
"Change from Baseline scapular muscle endurance at 1 months"
Time Frame: 1 month
|
Endurance of the trapezius and serratus anterior muscles was assessed using the scapular muscle endurance (SME) test.
|
1 month
|
"Change from Baseline self-efficacy at 1 months"
Time Frame: 1 month
|
Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOMalaga
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Tendinopathy
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-
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University of California, DavisCompletedRotator Cuff TendonitisUnited States
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GCS Ramsay Santé pour l'Enseignement et la RechercheRecruitingShoulder Rotator Cuff TendinitisFrance
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Afyonkarahisar Health Sciences UniversityCompletedMusculoskeletal Diseases | Shoulder Pain | Rotator Cuff Tendinopathy | Rotator Cuff SyndromeTurkey
Clinical Trials on Isoinertial + eccentric exercise
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Oslo University HospitalUniversity of OsloCompleted
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Queen Margaret UniversityUnknownTendinopathy | Achilles TendonUnited Kingdom
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Universidad Europea de MadridCompletedAchilles Tendinopathy | Diastasis RectiSpain
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Utah State UniversityNot yet recruitingBlood Flow Restriction
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Universidad Europea de MadridCompletedTendinopathy | Achilles TendonSpain
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New York Institute of TechnologyRecruitingHypermobility SyndromeUnited States
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Centre Hospitalier Universitaire de BesanconUnknownVentilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD (CONvEX)Chronic Obstructive Pulmonary Disease SevereFrance
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University Hospital, Clermont-FerrandUnknown
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Uppsala UniversityThe Swedish Research Council; Uppsala County Council, Sweden; Amersham FoundationCompleted
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Istinye UniversityCompleted