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

Okan University

Status: Completed

Conditions: Diabetes Mellitus; Frozen Shoulder

Treatments: Other: Placebo ESWT; Device: Extracorporeal Shock Wave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03185078

Okan University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups

Active Comparator: Low density ESWT Application

Experimental group

Description:

ESWT application will be done at energy density of 0.12 mJ/mm2.

Treatment:

Device: Extracorporeal Shock Wave Therapy

Other: Placebo ESWT

Active Comparator: High density ESWT Application

Experimental group

Description:

ESWT application will be done at an energy density of 0.3 mJ/mm2.

Treatment:

Device: Extracorporeal Shock Wave Therapy

Other: Placebo ESWT

Control

Sham Comparator group

Description:

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.

Treatment:

Other: Placebo ESWT