- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392934
Conservative Physiotherapy and Acromion Morphology
May 13, 2020 updated by: Begümhan Turhan, Hasan Kalyoncu University
The Short-term Effects of a Conservative Physiotherapy Method in Subacromial Impingement Syndrome and Its Relation to Acromion Morphology
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gaziantep, Turkey, 27000
- Hasan Kalyoncu University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: flat shape acromion group
a conservative physiotherapy protocol was applied for 4 weeks
|
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.
|
Experimental: curved shape acromion group
a conservative physiotherapy protocol was applied for 4 weeks
|
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.
|
Experimental: hooked shape acromion group
a conservative physiotherapy protocol was applied for 4 weeks
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 4 weeks
|
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).
|
4 weeks
|
Muscle strength
Time Frame: 4 weeks
|
Muscle strength tests for shoulder flexion, extension, abduction, adduction, internal and external rotation were done by a dynamometer (NK-500, AIPU, Anhui, China).
|
4 weeks
|
Range of motion
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Joint position sense
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Painful arc sign
Time Frame: 4 weeks
|
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
|
4 weeks
|
Functionality
Time Frame: 4 weeks
|
To assess the functional levels of the patients, the Shoulder Pain and Disability Index (SPADI) was used.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Begumhan Turhan, Hasan Kalyoncu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2020
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
May 11, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (Actual)
May 19, 2020
Study Record Updates
Last Update Posted (Actual)
May 19, 2020
Last Update Submitted That Met QC Criteria
May 13, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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