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Training in Subacromial Impingement Syndrome

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training
Sponsored by
Reumatologiklinikken
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring shoulder, rotator cuff, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subacromial impingement syndrome

Exclusion Criteria:

  • Ongoing claim with the Labour market insurance, insurance company or comparable institution.
  • Ongoing application for job revalidation or health related pension.
  • Radiating neck pain.
  • Ultrasound verified complete rotator cuff tendon lesion, as defined by hypoechoic or anechoic full thickness defect of the tendon, or absence of the tendon.
  • Periarthritis humeroscapularis.
  • Acute luxation or fracture of the shoulder.
  • Ongoing steady analgetic treatment of other concomitant painful condition, unrelated to the patients shoulder problem.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Supervised training regimen

    Home training regimen

    Arm Description

    This training regimen consisted of 3 phases: the 1st focused on restoring motion, the 2nd on strengthening of the rotator cuff muscles, and the 3rd on strengthening of the scapular muscles. Stretching completed every training session. Motion training consisted of 6 exercises. Postural training: shoulder shrugs and shoulder retraction exercises. Glenohumeral training: pendulum exercises, and active assisted flexion, abduction and external rotation. Strengthening of the rotator cuff: side lying external rotation, internal rotation and scaption. Strengthening of the scapular muscles: press-up, push-up with a plus, serratus anterior supine punch, standing rowing (low row), and seated rowing (high row). Training sessions ended with 4 stretches: anterior shoulder stretch, posterior shoulder stretch, inferior capsular stretch, sleepers stretch. Exercises were performed 3 times a week, with progression after the 1st week, and thereafter every 2nd week.

    The program consisted of the following: 1 motion exercise: upper trapezius relaxation 3 strengthening exercises: serratus anterior strengthening exercise, humeral external rotation with the arm at the side of the body, and humeral external rotation with a rubber band and the arm at 90 degrees abduction. 2 stretching exercises: posterior shoulder and pectoralis minor stretching, Exercises were performed daily, with weekly progression.

    Outcomes

    Primary Outcome Measures

    Shoulder constant score
    Functional assessment of the shoulder
    Shoulder Rating Questionnaire
    Self-administered questionnaire

    Secondary Outcome Measures

    Passive motion
    Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
    Active motion
    Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
    Visual Analogue Scale
    Measurement of pain on a 10 cm scale, where 0 indicates no pain, and 10 worst pain for the following muscle tests: full can test, empty can test, lift off test, resisted external rotation, palm-up test, Yergason´s test.
    Neer test
    Stabilization of the patient's scapula with one hand, while passively flexing the arm while it is internally rotated. If the patient reports pain in this position, then the result of the test is considered to be positive (rated positive = 1 and negative = 0).
    Hawkins test
    Placing the patient's shoulder in 90 degrees of shoulder flexion with the elbow flexed to 90 degrees, and afterwards internally rotating the arm. The test is considered to be positive if the patient experiences pain with internal rotation (rated positive = 1 and negative = 0).

    Full Information

    First Posted
    May 11, 2021
    Last Updated
    May 31, 2021
    Sponsor
    Reumatologiklinikken
    Collaborators
    Fonden for Faglig Udvikling af Speciallægepraksis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04915430
    Brief Title
    Training in Subacromial Impingement Syndrome
    Official Title
    Comprehensive Supervised Heavy Training Program Versus Home Training Regimen in Patients With Subacromial Impingement Syndrome: a Randomized Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (Actual)
    Primary Completion Date
    August 2018 (Actual)
    Study Completion Date
    August 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Reumatologiklinikken
    Collaborators
    Fonden for Faglig Udvikling af Speciallægepraksis

    4. Oversight

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

    5. Study Description

    Brief Summary
    A randomized controlled trial comparing a comprehensive supervised training regimen with a validated home-based regimen for subacromial impingement syndrome.
    Detailed Description
    The purpose of the study is to compare a comprehensive supervised training regimen (STR) based on latest evidence including heavy slow resistance training with a validated home-based regimen (HTR). We hypothesized that the STR would be superior to the HTR. Randomised control trial with blinded assessor. 126 consecutive patients with subacromial impingement syndrome were recruited and equally randomised to 12 weeks of either supervised training regimen (STR), or home-based training regimen (HTR). Primary outcomes were Constant Score (CS) and Shoulder Rating Questionnaire (SRQ) from baseline and 6 months after completed training. Results were analyzed according to intention-to treat principles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subacromial Impingement Syndrome
    Keywords
    shoulder, rotator cuff, exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients were randomized to either a supervised training regimen (STR) or a home training regimen
    Masking
    Investigator
    Masking Description
    The patients were blindly assigned to one of the training regimens.
    Allocation
    Randomized
    Enrollment
    126 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supervised training regimen
    Arm Type
    Active Comparator
    Arm Description
    This training regimen consisted of 3 phases: the 1st focused on restoring motion, the 2nd on strengthening of the rotator cuff muscles, and the 3rd on strengthening of the scapular muscles. Stretching completed every training session. Motion training consisted of 6 exercises. Postural training: shoulder shrugs and shoulder retraction exercises. Glenohumeral training: pendulum exercises, and active assisted flexion, abduction and external rotation. Strengthening of the rotator cuff: side lying external rotation, internal rotation and scaption. Strengthening of the scapular muscles: press-up, push-up with a plus, serratus anterior supine punch, standing rowing (low row), and seated rowing (high row). Training sessions ended with 4 stretches: anterior shoulder stretch, posterior shoulder stretch, inferior capsular stretch, sleepers stretch. Exercises were performed 3 times a week, with progression after the 1st week, and thereafter every 2nd week.
    Arm Title
    Home training regimen
    Arm Type
    Active Comparator
    Arm Description
    The program consisted of the following: 1 motion exercise: upper trapezius relaxation 3 strengthening exercises: serratus anterior strengthening exercise, humeral external rotation with the arm at the side of the body, and humeral external rotation with a rubber band and the arm at 90 degrees abduction. 2 stretching exercises: posterior shoulder and pectoralis minor stretching, Exercises were performed daily, with weekly progression.
    Intervention Type
    Other
    Intervention Name(s)
    Training
    Primary Outcome Measure Information:
    Title
    Shoulder constant score
    Description
    Functional assessment of the shoulder
    Time Frame
    6 months after ended training
    Title
    Shoulder Rating Questionnaire
    Description
    Self-administered questionnaire
    Time Frame
    6 months after ended training
    Secondary Outcome Measure Information:
    Title
    Passive motion
    Description
    Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
    Time Frame
    6 months after ended training
    Title
    Active motion
    Description
    Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
    Time Frame
    6 months after ended training
    Title
    Visual Analogue Scale
    Description
    Measurement of pain on a 10 cm scale, where 0 indicates no pain, and 10 worst pain for the following muscle tests: full can test, empty can test, lift off test, resisted external rotation, palm-up test, Yergason´s test.
    Time Frame
    6 months after ended training
    Title
    Neer test
    Description
    Stabilization of the patient's scapula with one hand, while passively flexing the arm while it is internally rotated. If the patient reports pain in this position, then the result of the test is considered to be positive (rated positive = 1 and negative = 0).
    Time Frame
    6 months after ended training
    Title
    Hawkins test
    Description
    Placing the patient's shoulder in 90 degrees of shoulder flexion with the elbow flexed to 90 degrees, and afterwards internally rotating the arm. The test is considered to be positive if the patient experiences pain with internal rotation (rated positive = 1 and negative = 0).
    Time Frame
    6 months after ended training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subacromial impingement syndrome Exclusion Criteria: Ongoing claim with the Labour market insurance, insurance company or comparable institution. Ongoing application for job revalidation or health related pension. Radiating neck pain. Ultrasound verified complete rotator cuff tendon lesion, as defined by hypoechoic or anechoic full thickness defect of the tendon, or absence of the tendon. Periarthritis humeroscapularis. Acute luxation or fracture of the shoulder. Ongoing steady analgetic treatment of other concomitant painful condition, unrelated to the patients shoulder problem.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre Schydlowsky, MD, PhD
    Organizational Affiliation
    Owner of the clinics
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35033043
    Citation
    Schydlowsky P, Szkudlarek M, Madsen OR. Comprehensive supervised heavy training program versus home training regimen in patients with subacromial impingement syndrome: a randomized trial. BMC Musculoskelet Disord. 2022 Jan 15;23(1):52. doi: 10.1186/s12891-021-04969-0.
    Results Reference
    derived

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    Training in Subacromial Impingement Syndrome

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