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Completed

NCT Number: NCT03568006

Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome

From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies.

The aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Jorge University

Villanueva de Gállego, Zaragoza, 50830, Spain

About this study

Subacromial syndrome, also known as subacromial impingement, is the most frequent disorder in the shoulder joint. It has a multifactorial origin and represents a wide spectrum of pathologies. Its main consequences are pain and loss of function in the glenohumeral joint. From a biomechanical point of view, subacromial syndrome causes an increment in the anterior and superior translation of the humeral head, which increases compression in the adjacent tissues of the subacromial space, aggravating the symptoms of the patients. Conservative treatments are the first option for subacromial syndrome management, despite the fact that there is limited evidence about its effectiveness, due to the lack of experimental studies.

The aim of this study is to evaluate the effectiveness of a passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint, within a multimodal approach to reduce pain and improve the range of motion in patients with subacromial syndrome. To this end, a randomized clinical trial will be carried out in the Montpellier Clinic in Zaragoza. Twenty-two patients will be recruited and randomly assigned to one of the two groups (intervention and control). Both groups will receive a standardized treatment consisting of: 10 sessions of infrared rays, and a program of therapeutic exercises and indications to improve their postural hygiene. In addition, the intervention group will receive a passive joint mobilization in the glenohumeral joint of 5 minutes. Pain intensity, range of motion and functionality of the glenohumeral joint will be measured in the first session before any treatment and in the tenth session after the treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of subacromial syndrome
  • Pain at rest, which increases when doing active movements
  • Neer´s impingement test positive
  • Hawkins Kennedy test positive
  • Pain lasting more than one month
  • Anteriorization of humeral head
  • Full capacity (physical and cognitive) to participate in the study and give consent.

Exclusion criteria

  • Infiltrations during the previous six months
  • Traumatic origin of pain
  • Complete tear of any rotator cuff tendon
  • Bilateral pain
  • Previous surgical intervention in the affected shoulder
  • Patients planning to start with other treatments during the clinical trial.

Treatment and study plan

Specific passive mobilization

Other

Specific passive mobilizations for the shoulder

Standardized treatment (standard protocol)

Other

Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: Change between baseline (immediately before intervention) and post intervention (2 weeks).

    10 centimetres Visual Analogue Scale. 0 is no pain, whilst 10 is maximum intolerable pain

Secondary outcomes

  1. Active range of motion

    Time frame: Change between baseline (immediately before intervention) and post intervention (2 weeks).

    Measurement of active range of motion for the different shoulder movements (abduction from 0 to 150º, flexion from 0 to 180º, extension from 0 to 60º, lateral rotation from 0 to 90º, internal rotation from o to 70º)

  2. Constant Score

    Time frame: Change between baseline (immediately before intervention) and post intervention (2 weeks).

    Scale to measure shoulder function, ranging from 0 to 100. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Collaborators

  • Montpellier Clinic

Registry information

Official study title

Effectiveness of Passive Mobilization of Glenohumeral Joint in Patients With Subacromial Syndrome: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Sep 19, 2018

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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