Clinical trial NCT04915430: 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
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: shoulder
rotator cuff
exercise
Lead sponsor: Reumatologiklinikken
Sponsor class: OTHER
Collaborators: name: Fonden for Faglig Udvikling af Speciallægepraksis
First posted: 2021-06-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized to either a supervised training regimen (STR) or a home training regimen
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Shoulder constant score
timeFrame: 6 months after ended training
measure: Shoulder Rating Questionnaire
timeFrame: 6 months after ended training
Secondary outcomes:
measure: Passive motion
timeFrame: 6 months after ended training
measure: Active motion
timeFrame: 6 months after ended training
measure: Visual Analogue Scale
timeFrame: 6 months after ended training
measure: Neer test
timeFrame: 6 months after ended training
measure: Hawkins test
timeFrame: 6 months after ended training
Other outcomes:
Locations:
Study officials:
affiliation: Owner of the clinics
name: Pierre Schydlowsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.