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Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome

Primary Purpose

Subacromial Impingement

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Specific passive mobilization
Standardized treatment (standard protocol)
Sponsored by
Universidad San Jorge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement focused on measuring subacromial impingement, pain, shoulder, passive mobilization

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Jorge University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Intervention will consist of passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint. Besides, participants will receive a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene.

Control treatment will consist of a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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.

Full Information

First Posted
June 12, 2018
Last Updated
September 17, 2018
Sponsor
Universidad San Jorge
Collaborators
Montpellier Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03568006
Brief Title
Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome
Official Title
Effectiveness of Passive Mobilization of Glenohumeral Joint in Patients With Subacromial Syndrome: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad San Jorge
Collaborators
Montpellier Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement
Keywords
subacromial impingement, pain, shoulder, passive mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
It is not possible to mask physiotherapists and patients, so the only masking will be for researchers and evaluators
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention will consist of passive joint mobilization (caudal and dorsal gliding) grade II in the glenohumeral joint. Besides, participants will receive a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control treatment will consist of a standardized treatment consisting of infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene.
Intervention Type
Other
Intervention Name(s)
Specific passive mobilization
Intervention Description
Specific passive mobilizations for the shoulder
Intervention Type
Other
Intervention Name(s)
Standardized treatment (standard protocol)
Intervention Description
Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
10 centimetres Visual Analogue Scale. 0 is no pain, whilst 10 is maximum intolerable pain
Time Frame
Change between baseline (immediately before intervention) and post intervention (2 weeks).
Secondary Outcome Measure Information:
Title
Active range of motion
Description
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)
Time Frame
Change between baseline (immediately before intervention) and post intervention (2 weeks).
Title
Constant Score
Description
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.
Time Frame
Change between baseline (immediately before intervention) and post intervention (2 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
San Jorge University
City
Villanueva de Gallego
State/Province
Zaragoza
ZIP/Postal Code
50830
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome

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