Training in Subacromial Impingement Syndrome

May 31, 2021 updated by: Reumatologiklinikken

Comprehensive Supervised Heavy Training Program Versus Home Training Regimen in Patients With Subacromial Impingement Syndrome: a Randomized Trial.

A randomized controlled trial comparing a comprehensive supervised training regimen with a validated home-based regimen for subacromial impingement syndrome.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Supervised training regimen

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.

Active Comparator: Home training regimen

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder constant score
Time Frame: 6 months after ended training
Functional assessment of the shoulder
6 months after ended training
Shoulder Rating Questionnaire
Time Frame: 6 months after ended training
Self-administered questionnaire
6 months after ended training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Passive motion
Time Frame: 6 months after ended training
Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
6 months after ended training
Active motion
Time Frame: 6 months after ended training
Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
6 months after ended training
Visual Analogue Scale
Time Frame: 6 months after ended training
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.
6 months after ended training
Neer test
Time Frame: 6 months after ended training
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).
6 months after ended training
Hawkins test
Time Frame: 6 months after ended training
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).
6 months after ended training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierre Schydlowsky, MD, PhD, Owner of the clinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

May 31, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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