Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03568006
Other study ID # TM_AJ
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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).
See also
  Status Clinical Trial Phase
Terminated NCT03913702 - Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement Phase 2
Completed NCT04833738 - Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome N/A
Completed NCT05549674 - Copenhagen Cohort of Patients With Shoulder Pain
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Completed NCT02971215 - Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy N/A
Completed NCT04759027 - Reliability of the Subacromial Distance Measurements With Standard Radiographic Imaging
Completed NCT03735485 - Comparison of the Proprioceptive Neuromuscular Facilitation and Mobilization In Subacromial Impingement Syndrome N/A
Completed NCT01510639 - The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery Phase 3
Not yet recruiting NCT05882786 - Corticosteroid Injection Versus Tendon Dry Needling for Subacromial Impingement Syndrome N/A
Recruiting NCT04865380 - Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair Phase 3
Completed NCT03109704 - Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome N/A
Completed NCT06106048 - Comparative Effects of Conscious Abdominal Contraction and Closed Kinetic Chain Exercises N/A
Completed NCT04599127 - The Effect of Mobilization With Movement in Individuals With Shoulder Impingement Syndrome N/A
Recruiting NCT02304003 - The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy N/A