Effects of Isoinertial Training on Rotator Cuff Tendinopathy

NCT02982460 | Unknown DMC

• 1 other identifier: UOMalaga
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Tendinopathy

Keywords

Rotator cuff tendinopathy; Eccentric exercise; Isoinertial training

Outcome Measures

Primary Outcomes (2)

• "Change from Baseline function at 1 month"

  This outcome will be measured with the shoulder pain and disability index (SPADI)

  1 month

• "Change from Baseline pain at 1 month"

  This outcome will be measured with the shoulder pain and disability index (SPADI)

  1 month

Secondary Outcomes (4)

• "Change from Baseline rotator cuff strength at 1 months"

  1 month

• "Change from Baseline scapular muscle activity at 1 months"

  1 month

• "Change from Baseline scapular muscle endurance at 1 months"

  1 month

• "Change from Baseline self-efficacy at 1 months"

  1 month

Study Arms (2)

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.

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.

Other: Eccentric exercise

Interventions

Isoinertial + eccentric exercise OTHER

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

Isoinertial + eccentric exercise

Eccentric exercise OTHER

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

Eccentric exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Officials

• Alejandro Luque Suarez, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Martinez Calderon, PhD student

CONTACT

655570595; javier_martinez_calderon@hotmail.com

Alejandro Luque Suarez, PhD

CONTACT

606939920; aluques@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 5, 2016
• Study Start: December 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share