Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome

Subacromial Impingement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568006
• Other study ID #: TM_AJ
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 17, 2018

Study information

• Verified date: September 2018
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement

Intervention

Other:
• Specific passive mobilization
Specific passive mobilizations for the shoulder
• Standardized treatment (standard protocol)
Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene

Locations

Country	Name	City	State
Spain	San Jorge University	Villanueva de Gallego	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Universidad San Jorge	Montpellier Clinic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	10 centimetres Visual Analogue Scale. 0 is no pain, whilst 10 is maximum intolerable pain	Change between baseline (immediately before intervention) and post intervention (2 weeks).
Secondary	Active range of motion	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)	Change between baseline (immediately before intervention) and post intervention (2 weeks).
Secondary	Constant Score	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.	Change between baseline (immediately before intervention) and post intervention (2 weeks).