Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder

NCT ID: NCT03185078

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2019-09-17

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.

Conditions

Frozen Shoulder; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Comparator: Low density ESWT Application

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

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy

Intervention Type: DEVICE

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

Placebo ESWT

Intervention Type: OTHER

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.

Active Comparator: High density ESWT Application

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

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy

Intervention Type: DEVICE

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

Placebo ESWT

Intervention Type: OTHER

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.

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.

Group Type: SHAM_COMPARATOR

Placebo ESWT

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: collaborator

Okan University

OTHER

Sponsor Role: lead

Responsible Party

Tülay Çevik

PT, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Okan University Hospital

Istanbul, Tuzla, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Okan University

Identifier Type: -

Identifier Source: org_study_id