Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder

Not Applicable

Completed

• Conditions: Frozen Shoulder; Diabetes Mellitus
• Interventions: Device: Extracorporeal Shock Wave Therapy; Other: Placebo ESWT

• Registration Number: NCT03185078
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Start: 2019-01-25
• Status Verified: 2019-09
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-17
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: Low density ESWT Application	Extracorporeal Shock Wave Therapy	ESWT application will be done at energy density of 0.12 mJ/mm2.
Active Comparator: High density ESWT Application	Placebo ESWT	ESWT application will be done at an energy density of 0.3 mJ/mm2.
Active Comparator: Low density ESWT Application	Placebo ESWT	ESWT application will be done at energy density of 0.12 mJ/mm2.
Active Comparator: High density ESWT Application	Extracorporeal Shock Wave Therapy	ESWT application will be done at an energy density of 0.3 mJ/mm2.
Control	Placebo ESWT	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.

Primary Outcome Measures

Name	Time	Method
SPADI	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.
VAS	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

Trial Locations

Locations (1)

Istanbul Okan University Hospital; 🇹🇷 Istanbul, Tuzla, Turkey