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Completed

NCT Number: NCT04915430

Training in Subacromial Impingement Syndrome

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

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Key information

Conditions

Subacromial Impingement Syndrome Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Shoulder Impingement Syndrome Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training

Other

Primary outcomes

  1. Shoulder constant score

    Time frame: 6 months after ended training

    Functional assessment of the shoulder

  2. Shoulder Rating Questionnaire

    Time frame: 6 months after ended training

    Self-administered questionnaire

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Reumatologiklinikken

Other

Collaborators

  • Fonden for Faglig Udvikling af Speciallægepraksis

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2021
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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