search
Back to results

Effects of Isoinertial Training on Rotator Cuff Tendinopathy

Primary Purpose

Rotator Cuff Tendinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Isoinertial + eccentric exercise
Eccentric exercise
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinopathy focused on measuring Rotator cuff tendinopathy, Eccentric exercise, Isoinertial training

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Isoinertial + eccentric exercise

    Eccentric exercise

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    "Change from Baseline function at 1 month"
    This outcome will be measured with the shoulder pain and disability index (SPADI)
    "Change from Baseline pain at 1 month"
    This outcome will be measured with the shoulder pain and disability index (SPADI)

    Secondary Outcome Measures

    "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.
    "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.
    "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.
    "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.

    Full Information

    First Posted
    November 27, 2016
    Last Updated
    October 11, 2018
    Sponsor
    University of Malaga
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02982460
    Brief Title
    Effects of Isoinertial Training on Rotator Cuff Tendinopathy
    Official Title
    The Effects of Isoinertial Training on Rotator Cuff Tendinopathy. A Randomized Controlled Double-blind Follow-up Trail. A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaga

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tendinopathy
    Keywords
    Rotator cuff tendinopathy, Eccentric exercise, Isoinertial training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Isoinertial + eccentric exercise
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Eccentric exercise
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Isoinertial + eccentric exercise
    Intervention Description
    A session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles.
    Intervention Type
    Other
    Intervention Name(s)
    Eccentric exercise
    Intervention Description
    A session of eccentric exercise covers the strength of scapular muscles.
    Primary Outcome Measure Information:
    Title
    "Change from Baseline function at 1 month"
    Description
    This outcome will be measured with the shoulder pain and disability index (SPADI)
    Time Frame
    1 month
    Title
    "Change from Baseline pain at 1 month"
    Description
    This outcome will be measured with the shoulder pain and disability index (SPADI)
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    "Change from Baseline rotator cuff strength at 1 months"
    Description
    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.
    Time Frame
    1 month
    Title
    "Change from Baseline scapular muscle activity at 1 months"
    Description
    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.
    Time Frame
    1 month
    Title
    "Change from Baseline scapular muscle endurance at 1 months"
    Description
    Endurance of the trapezius and serratus anterior muscles was assessed using the scapular muscle endurance (SME) test.
    Time Frame
    1 month
    Title
    "Change from Baseline self-efficacy at 1 months"
    Description
    Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Javier Martinez Calderon, PhD student
    Phone
    655570595
    Ext
    +34
    Email
    javier_martinez_calderon@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alejandro Luque Suarez, PhD
    Phone
    606939920
    Ext
    +34
    Email
    aluques@uma.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alejandro Luque Suarez, PhD
    Organizational Affiliation
    University of Malaga
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Isoinertial Training on Rotator Cuff Tendinopathy

    We'll reach out to this number within 24 hrs