Training in Subacromial Impingement Syndrome

Sponsor

Reumatologiklinikken (Other)

Overall Status

Completed

CT.gov ID

NCT04915430

Collaborator

Fonden for Faglig Udvikling af Speciallægepraksis (Other)

126

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Subacromial Impingement Syndrome	Other: Training	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients were randomized to either a supervised training regimen (STR) or a home training regimenPatients were randomized to either a supervised training regimen (STR) or a home training regimen

Masking:

Single (Investigator)

Masking Description:

The patients were blindly assigned to one of the training regimens.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

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.	Other: Training
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.	Other: Training

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.

Other: Training

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.

Other: Training

Outcome Measures

Primary Outcome Measures

Shoulder constant score [6 months after ended training]
Functional assessment of the shoulder
Shoulder Rating Questionnaire [6 months after ended training]
Self-administered questionnaire

Secondary Outcome Measures

Passive motion [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.
Active motion [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.
Visual Analogue Scale [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.
Neer test [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).
Hawkins test [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.