Effects of Isoinertial Training on Rotator Cuff Tendinopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02982460|
Recruitment Status : Not yet recruiting
First Posted : December 5, 2016
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tendinopathy||Other: Isoinertial + eccentric exercise Other: Eccentric exercise||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||The Effects of Isoinertial Training on Rotator Cuff Tendinopathy. A Randomized Controlled Double-blind Follow-up Trail. A Pilot Study|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||December 2019|
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.
Other: Isoinertial + eccentric exercise
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.
Other: Eccentric exercise
A session of eccentric exercise covers the strength of scapular muscles.
- "Change from Baseline function at 1 month" [ Time Frame: 1 month ]This outcome will be measured with the shoulder pain and disability index (SPADI)
- "Change from Baseline pain at 1 month" [ Time Frame: 1 month ]This outcome will be measured with the shoulder pain and disability index (SPADI)
- "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.
- "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.
- "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.
- "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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982460
|Contact: Javier Martinez Calderon, PhD student||655570595 ext +email@example.com|
|Contact: Alejandro Luque Suarez, PhD||606939920 ext +firstname.lastname@example.org|
|Principal Investigator:||Alejandro Luque Suarez, PhD||University of Malaga|