Effects of Isoinertial Training on Rotator Cuff Tendinopathy

NCT ID: NCT02982460

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2020-01-31

Brief 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 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.

Conditions

Rotator Cuff Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Isoinertial + eccentric exercise

Intervention Type: OTHER

A session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles.

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.

Group Type: ACTIVE_COMPARATOR

Eccentric exercise

Intervention Type: OTHER

A session of eccentric exercise covers the strength of scapular muscles.

Interventions

Isoinertial + eccentric exercise

A session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles.

Intervention Type: OTHER

Eccentric exercise

A session of eccentric exercise covers the strength of scapular muscles.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Alejandro Luque-Suarez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alejandro Luque Suarez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Central Contacts

Javier Martinez Calderon, PhD student

Role: CONTACT

javier_martinez_calderon@hotmail.com

655570595 ext. +34

Alejandro Luque Suarez, PhD

Role: CONTACT

aluques@uma.es

606939920 ext. +34

Other Identifiers

UOMalaga

Identifier Type: -

Identifier Source: org_study_id