NCT04915430

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Last Updated

June 7, 2021

Status Verified

May 1, 2021

Enrollment Period

4.9 years

First QC Date

May 11, 2021

Last Update Submit

May 31, 2021

Conditions

Keywords

shoulderrotator cuffexercise

Outcome Measures

Primary Outcomes (2)

  • Shoulder constant score

    Functional assessment of the shoulder

    6 months after ended training

  • Shoulder Rating Questionnaire

    Self-administered questionnaire

    6 months after ended training

Secondary Outcomes (5)

  • Passive motion

    6 months after ended training

  • Active motion

    6 months after ended training

  • Visual Analogue Scale

    6 months after ended training

  • Neer test

    6 months after ended training

  • Hawkins test

    6 months after ended training

Study Arms (2)

Supervised training regimen

ACTIVE COMPARATOR

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

Home training regimen

ACTIVE COMPARATOR

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

Interventions

Home training regimenSupervised training regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subacromial impingement syndrome

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Shoulder Impingement SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesBehavior

Study Officials

  • Pierre Schydlowsky, MD, PhD

    Owner of the clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The patients were blindly assigned to one of the training regimens.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients were randomized to either a supervised training regimen (STR) or a home training regimen
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

June 7, 2021

Study Start

September 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

June 7, 2021

Record last verified: 2021-05