Back to resultsConservative Physiotherapy and Acromion Morphology
Primary Purpose
Subacromial Impingement Syndrome, Morphologic Change
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
a conservative physiotherapy protocol
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring physiotherapy, acromion morphology, subacromial impingement syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients who were diagnosed (clinically and by MRI) with SIS by the physician, at a stage of II-III levels according to Neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study.
Exclusion Criteria:
- Patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded.
Sites / Locations
- Hasan Kalyoncu University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
flat shape acromion group
curved shape acromion group
hooked shape acromion group
Arm Description
a conservative physiotherapy protocol was applied for 4 weeks
a conservative physiotherapy protocol was applied for 4 weeks
a conservative physiotherapy protocol was applied for 4 weeks
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
Pain at rest and pain at activity was measured by Visual Analog Scale (VAS). High score was determined as high level of pain. Visual analog scale (VAS) was ranging from 0 cm (no pain) to 10 cm (worst imaginable pain).
Muscle strength
Muscle strength tests for shoulder flexion, extension, abduction, adduction, internal and external rotation were done by a dynamometer (NK-500, AIPU, Anhui, China).
Range of motion
Goniometric measurements were applied by a universal goniometer to determine the range of motion in terms of flexion, extension, abduction, adduction, internal and external rotation directions.
Joint position sense
The joint position sense was evaluated by a laser pointer. During the test, 90˚ shoulder flexion and 90˚ shoulder abduction movements were evaluated. A laser pointer was fixed with a velcro 5 cm above the elbow. The patient was asked to bring the shoulder to 90˚ flexion while the patient's eyes were open and meanwhile, the measurement was made by the physiotherapist with a goniometer. The patient was asked to fix this position for 10 seconds. The projection of the laser pointer on millimeter paper was marked. The patient repeated this movement 3 times with eyes open and memorized it. The patient returned to the neutral position and closed her eyes then repeated the flexion movement 3 times and the projection of the laser pointer on millimeter paper was marked. The same procedure was performed for shoulder abduction. The deviation between the measurements was calculated.
Painful arc sign
The patient was asked to perform active shoulder abduction, and the difference between the angle at which the pain first occurred and the angle at which the pain ended was noted during this movement pattern. Measurements were made on the affected shoulder joint by a goniometer
Functionality
To assess the functional levels of the patients, the Shoulder Pain and Disability Index (SPADI) was used.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04392934
Brief Title
Conservative Physiotherapy and Acromion Morphology
Official Title
The Short-term Effects of a Conservative Physiotherapy Method in Subacromial Impingement Syndrome and Its Relation to Acromion Morphology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University
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
In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology.
Detailed Description
The aim of this study is to investigate the short term effects of physiotherapy in SIS patients on pain, range of motion, muscle strength, joint position sense and functionality and its relation to the acromion shape. Fifty patients (26 female, 24 male) with SIS were evaluated in this study. Patiens were divided into 3 groups according to the their acromion morphology. A conservative physiotherapy method was applied to the patients. All patients were evaluated before and 4 weeks after the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome, Morphologic Change
Keywords
physiotherapy, acromion morphology, subacromial impingement syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Participants are grouped according to their acromion type. First group is flat shape acromion group, second is hook shape group and the third one is curved shape acromion group. All groups are treated with the same physiotherapy protocol.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
flat shape acromion group
Arm Type
Experimental
Arm Description
a conservative physiotherapy protocol was applied for 4 weeks
Arm Title
curved shape acromion group
Arm Type
Experimental
Arm Description
a conservative physiotherapy protocol was applied for 4 weeks
Arm Title
hooked shape acromion group
Arm Type
Experimental
Arm Description
a conservative physiotherapy protocol was applied for 4 weeks
Intervention Type
Procedure
Intervention Name(s)
a conservative physiotherapy protocol
Intervention Description
5 minutes of ultrasound (Business Line US 50, Medical Italia, Italy) at a frequency of 1 MHz and intensity of 1.5 watts/cm², 20 minutes of conventional TENS (BTL-5000, UK ) applied to the patients. Then Codman's exercises, shoulder wheel activity, isometric exercises, range of motion exercises, capsular stretching, scapular stabilization exercises, and muscle strengthening exercises were done by patients. After the treatment, cold pack was applied to the shoulder for 10 minutes. The modalities in the treatment program were applied for a total of 20 sessions 5 days per week.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Pain at rest and pain at activity was measured by Visual Analog Scale (VAS). High score was determined as high level of pain. Visual analog scale (VAS) was ranging from 0 cm (no pain) to 10 cm (worst imaginable pain).
Time Frame
4 weeks
Title
Muscle strength
Description
Muscle strength tests for shoulder flexion, extension, abduction, adduction, internal and external rotation were done by a dynamometer (NK-500, AIPU, Anhui, China).
Time Frame
4 weeks
Title
Range of motion
Description
Goniometric measurements were applied by a universal goniometer to determine the range of motion in terms of flexion, extension, abduction, adduction, internal and external rotation directions.
Time Frame
4 weeks
Title
Joint position sense
Description
The joint position sense was evaluated by a laser pointer. During the test, 90˚ shoulder flexion and 90˚ shoulder abduction movements were evaluated. A laser pointer was fixed with a velcro 5 cm above the elbow. The patient was asked to bring the shoulder to 90˚ flexion while the patient's eyes were open and meanwhile, the measurement was made by the physiotherapist with a goniometer. The patient was asked to fix this position for 10 seconds. The projection of the laser pointer on millimeter paper was marked. The patient repeated this movement 3 times with eyes open and memorized it. The patient returned to the neutral position and closed her eyes then repeated the flexion movement 3 times and the projection of the laser pointer on millimeter paper was marked. The same procedure was performed for shoulder abduction. The deviation between the measurements was calculated.
Time Frame
4 weeks
Title
Painful arc sign
Description
The patient was asked to perform active shoulder abduction, and the difference between the angle at which the pain first occurred and the angle at which the pain ended was noted during this movement pattern. Measurements were made on the affected shoulder joint by a goniometer
Time Frame
4 weeks
Title
Functionality
Description
To assess the functional levels of the patients, the Shoulder Pain and Disability Index (SPADI) was used.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who were diagnosed (clinically and by MRI) with SIS by the physician, at a stage of II-III levels according to Neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study.
Exclusion Criteria:
Patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Begumhan Turhan
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Conservative Physiotherapy and Acromion Morphology
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