Effectiveness of Passive Mobilization in Patients With Subacromial Syndrome

Sponsor
Universidad San Jorge (Other)
Overall Status
Completed
CT.gov ID
NCT03568006
Collaborator
Montpellier Clinic (Other)
22
1
2
2.6
8.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Specific passive mobilization
  • Other: Standardized treatment (standard protocol)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
It is not possible to mask physiotherapists and patients, so the only masking will be for researchers and evaluators
Primary Purpose:
Treatment
Official Title:
Effectiveness of Passive Mobilization of Glenohumeral Joint in Patients With Subacromial Syndrome: a Randomized Controlled Trial
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Sep 17, 2018
Actual Study Completion Date :
Sep 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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.

Other: Specific passive mobilization
Specific passive mobilizations for the shoulder

Other: Standardized treatment (standard protocol)
Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene

Active Comparator: Control

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

Other: Standardized treatment (standard protocol)
Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) [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 Outcome Measures

  1. Active range of motion [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Jorge University Villanueva de Gallego Zaragoza Spain 50830

Sponsors and Collaborators

  • Universidad San Jorge
  • Montpellier Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pablo Herrero Gallego, Dr. Pablo Herrero, PT, PhD. Head of iPhysio Research Group., Universidad San Jorge
ClinicalTrials.gov Identifier:
NCT03568006
Other Study ID Numbers:
  • TM_AJ
First Posted:
Jun 26, 2018
Last Update Posted:
Sep 19, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pablo Herrero Gallego, Dr. Pablo Herrero, PT, PhD. Head of iPhysio Research Group., Universidad San Jorge
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 19, 2018