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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04915430
Other study ID # PS_01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date August 2018

Study information

Verified date May 2021
Source Reumatologiklinikken
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Training


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Reumatologiklinikken Fonden for Faglig Udvikling af Speciallægepraksis

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder constant score Functional assessment of the shoulder 6 months after ended training
Primary Shoulder Rating Questionnaire Self-administered questionnaire 6 months after ended training
Secondary Passive motion 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
Secondary Active motion 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
Secondary 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. 6 months after ended training
Secondary 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). 6 months after ended training
Secondary 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). 6 months after ended training
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