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Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder (RCT)

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ClinicalTrials.gov Identifier: NCT03185078
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Medipol University
Information provided by (Responsible Party):
Tülay Çevik, Okan University

Brief Summary:
The aim of this study is to observe the changes in the combined ESWT application and physiotherapy program in the frozen shoulder pathology associated with diabetes. Different treatment approaches will try to identify the most effective treatment method. Changes in muscle tone, pain, range of motion and functionallity will be observed with ESWT treatment. For the first time placebo-controlled research is being conducted with different doses of ESWT in our country and in the World literature. In this way the lower floor of the further work to be done will be established.

Condition or disease Intervention/treatment Phase
Frozen Shoulder Diabetes Mellitus Device: Extracorporeal Shock Wave Therapy Other: Placebo ESWT Not Applicable

Detailed Description:
The study will be performed with participants who has diabetic frozen shoulder diagnosis after clinical examination and imaging procedures performed, held at Okan University Hospital, Physical Therapy and Rehabilitation Clinic. Data will be recorded with the shoulder evaluation form in the study and cases will be divided into three groups with simple randomization method. The initial range of motion of the participants will be evaluated bilaterally using an electro-goniometer. The muscle tone evaluation will be made with MyotonPro. Muscle strength assessment will be performed with the MicroFET2 dynamometer at the appropriate measurement positions. Participants' pain assessment will be done in the rest, activity and night pain using the Visual Analog Scale. The Shoulder Pain Disability Scale will be used to assess participants' shoulder function. The short-form-36 questionnaire will be used evaluating the quality of life. Physiotherapy application will be applied to all three groups in the form of standard treatment protocol, duration and number. For the first group ESWT application will be done at energy density of 0.12 mJ/mm2, in the second group, at an energy density of 0.3 mJ/mm2, for the third group application will be done as sham ESWT. The ESWT will be administered once a week and in two separate sessions of 2000 strokes. After initial measurements, re-evaluations will be done in the fourth and sixth weeks. The statistics will be analyzed by appropriate methods.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Doses of Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder
Actual Study Start Date : January 25, 2019
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : September 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Active Comparator: Low density ESWT Application
ESWT application will be done at energy density of 0.12 mJ/mm2.
Device: Extracorporeal Shock Wave Therapy
Extracorporeal shock wave therapy (ESWT) is a treatment method for the application of single-pulse acoustic pressure waves generated by sudden changes in pressure by creating shock waves with piezoelectric, electrohydraulic and electromagnetic systems. It has been reported that ESWT treatment is effective in the treatment of pain with hyperstimulation analgesia by inhibiting afferent pain receptors, and also improve angiogenesis and restore and reorganize the musculoskeletal system

Other: Placebo ESWT
In the placebo application, rESWT device was switched on but without pressing the pedal during the same session period. The applicator was positioned to be the same as the other groups.

Experimental: Active Comparator: High density ESWT Application
ESWT application will be done at an energy density of 0.3 mJ/mm2.
Device: Extracorporeal Shock Wave Therapy
Extracorporeal shock wave therapy (ESWT) is a treatment method for the application of single-pulse acoustic pressure waves generated by sudden changes in pressure by creating shock waves with piezoelectric, electrohydraulic and electromagnetic systems. It has been reported that ESWT treatment is effective in the treatment of pain with hyperstimulation analgesia by inhibiting afferent pain receptors, and also improve angiogenesis and restore and reorganize the musculoskeletal system

Other: Placebo ESWT
In the placebo application, rESWT device was switched on but without pressing the pedal during the same session period. The applicator was positioned to be the same as the other groups.

Sham Comparator: Control
The ESWT application will be executed when the ESWT application is in the off position. During application, pre-recorded sound beats will be played to the treatment group.
Other: Placebo ESWT
In the placebo application, rESWT device was switched on but without pressing the pedal during the same session period. The applicator was positioned to be the same as the other groups.




Primary Outcome Measures :
  1. SPADI [ Time Frame: Change from baseline shoulder functionality, at the 4th week and at the 6th week. ]
    The Shoulder Pain and Disability Index. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.

  2. VAS [ Time Frame: Change will be assessed about pain, at the 4th week and at the 6th week from baseline ]

    Visual Analog Scale In the study, the chart on the 10 cm length of the diseased pain

    0: painless; 10: It was told that it was unbearable pain.

    Patients were asked to mark the appropriate interval for their pain. The point marked by the patient was measured and recorded with the aid of a ruler




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Sex: No limit on eligibility based on the sex of participants.

Gender: Eligibility is not based on gender.

Age Limits:

Minimum Age: 30 years Maximum Age: 65

Inclusion Criteria:

Pain in the shoulder joint longer than for six weeks The shoulder joint movements of cases at least two of the abduction, flexion, external rotation, and internal rotation movements with a limitation of motion > 50% Differentiated from other pathologies according to shoulder MRI results

Exclusion Criteria:

Limitation of pain due to cervical radiculopathy Rotator cuff massive tears Recurrent subluxation Trauma or patients with active infection Using cardiac pills, patients Blood coagulation disorders Neurologic causes-restriction of movement in shoulder joint due to cerebrovascular pathologies, Limitation of movement due to rheumatic causes

Sampling Method: Simple random sampling


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185078


Locations
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Turkey
Istanbul Okan University Hospital
Istanbul, Tuzla, Turkey, 34949
Sponsors and Collaborators
Okan University
Medipol University

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Responsible Party: Tülay Çevik, PT, MSc, Okan University
ClinicalTrials.gov Identifier: NCT03185078     History of Changes
Other Study ID Numbers: Okan University
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tülay Çevik, Okan University:
physical therapy
ESWT
Additional relevant MeSH terms:
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Bursitis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Joint Diseases
Musculoskeletal Diseases