Rotator Cuff TendinopathyNCT02982460
Effects of Isoinertial Training on Rotator Cuff Tendinopathy
A study testing Isoinertial + eccentric exercise and Eccentric exercise in people with Rotator Cuff Tendinopathy, run by University of Malaga.
Trial summary
Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder pain with prevalence estimated to be as high as 14% in general working-age population. RCT is a broad entity, including a vast variety of diagnosis such as shoulder impingement syndrome, RC tendinitis/tendinosis, as well as… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Isoinertial + eccentric exercise and Eccentric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Jan 2020
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Isoinertial Training on Rotator Cuff Tendinopathy. A Randomized Controlled Double-blind Follow-up Trail. A Pilot Study
Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder pain with prevalence estimated to be as high as 14% in general working-age population. RCT is a broad entity, including a vast variety of diagnosis such as shoulder impingement syndrome, RC tendinitis/tendinosis, as well as subacromial bursitis. The course of RCT is characterised by persistent pain and/or disability and/or recurrent episodes. It often leads to decrease function, lower health-related quality of life, poor sleep quality, work absenteeism, as well as patient's suffering. Previous studies support exercise as an adequate treatment in RCT. Nevertheless, our knowledge, there is no studies evaluating the effects of isoinertial training in RCT. Therefore, the aim of this study will be to pilot the methods proposed to conduct a substantive study to evaluate the efficacy of isoinertial training plus eccentric training versus eccentric training alone on improving pain and function in RCT. The objectives were to evaluate: (i) The process of recruitment and retention rates; (ii) Willingness of participants to be randomised; (iii) The extent of contamination between groups; (iv) Participant adherence with treatment. The secondary aim will be to analyse the effects of isoinertial training plus eccentric training versus eccentric training alone on rotator cuff strength, scapular muscle activity, and scapular muscle endurance in people with RCT.
Read the 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.
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- Isoinertial + eccentric exercise, Eccentric exercise
- Keywords
- Rotator cuff tendinopathy, Eccentric exercise, Isoinertial training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoinertial + eccentric exerciseOther
A session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles.
Eccentric exerciseOther
A session of eccentric exercise covers the strength of scapular muscles.
| Study group | Role | What they receive |
|---|---|---|
| Isoinertial + eccentric exercise | Experimental | 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. Receives: Other: Isoinertial + eccentric exercise |
| Eccentric exercise | Active comparator | 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. Receives: Other: Eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Change from Baseline function at 1 month"
This outcome will be measured with the shoulder pain and disability index (SPADI)
Measured: 1 month
"Change from Baseline pain at 1 month"
This outcome will be measured with the shoulder pain and disability index (SPADI)
Measured: 1 month
Secondary outcomes (4)
"Change from Baseline rotator cuff strength at 1 months"
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.
Measured: 1 month
"Change from Baseline scapular muscle activity at 1 months"
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.
Measured: 1 month
"Change from Baseline scapular muscle endurance at 1 months"
Endurance of the trapezius and serratus anterior muscles was assessed using the scapular muscle endurance (SME) test.
Measured: 1 month
"Change from Baseline self-efficacy at 1 months"
Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startDec 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinopathyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Luque-Suarez, University of Malaga
- Investigators
- Alejandro Luque Suarez, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982460
- Sponsor's protocol ID
- UOMalaga
- Status last verified
- Oct 2018
- First submitted
- 27 Nov 2016
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Isoinertial Training on Rotator Cuff Tendinopathy. A Randomized Controlled Double-blind Follow-up Trail. A Pilot Study
- ClinicalTrials.gov ID
- NCT02982460
- Acronym / sponsor ID
- UOMalaga
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- Rotator cuff tendinopathy, Eccentric exercise, Isoinertial training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 5 Dec 2016 (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.
Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder pain with prevalence estimated to be as high as 14% in general working-age population. RCT is a broad entity, including a vast variety of diagnosis such as shoulder impingement syndrome, RC tendinitis/tendinosis, as well as subacromial bursitis. The course of RCT is characterised by persistent pain and/or disability and/or recurrent episodes. It often leads to decrease function, lower health-related quality of life, poor sleep quality, work absenteeism, as well as patient's suffering. Previous studies support exercise as an adequate treatment in RCT. Nevertheless, our knowledge, there is no studies evaluating the effects of isoinertial training in RCT. Therefore, the aim of this study will be to pilot the methods proposed to conduct a substantive study to evaluate the efficacy of isoinertial training plus eccentric training versus eccentric training alone on improving pain and function in RCT. The objectives were to evaluate: (i) The process of recruitment and retention rates; (ii) Willingness of participants to be randomised; (iii) The extent of contamination between groups; (iv) Participant adherence with treatment. The secondary aim will be to analyse the effects of isoinertial training plus eccentric training versus eccentric training alone on rotator cuff strength, scapular muscle activity, and scapular muscle endurance in people with RCT.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoinertial + eccentric exercise | Experimental | Other: Isoinertial + eccentric exerciseThe 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. |
| Eccentric exercise | Active comparator | Other: Eccentric exerciseEccentric 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Isoinertial + eccentric exerciseA session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles. | Other | Isoinertial + eccentric exercise |
| Eccentric exerciseA session of eccentric exercise covers the strength of scapular muscles. | Other | Eccentric exercise |
Primary outcome
"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)
4 secondary outcomes
"Change from Baseline rotator cuff strength at 1 months"
Time frame: 1 month
"Change from Baseline scapular muscle activity at 1 months"
Time frame: 1 month
"Change from Baseline scapular muscle endurance at 1 months"
Time frame: 1 month
"Change from Baseline self-efficacy at 1 months"
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Alejandro Luque Suarez, PhD principal investigator
University of Malaga
Questions about this trial
What is this clinical trial studying?
A study testing Isoinertial + eccentric exercise and Eccentric exercise in people with Rotator Cuff Tendinopathy, run by University of Malaga.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Martinez Calderon, PhD student (655570595 ext. +34, javier_martinez_calderon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Change from Baseline function at 1 month" (time frame: 1 month). The study lists 2 primary outcomes in all. 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 12 Oct 2018.