Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder

NCT03185078 | Completed

• 1 other identifier: Okan University
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Frozen Shoulder; Diabetes Mellitus

Keywords

physical therapy; ESWT

Outcome Measures

Primary Outcomes (2)

• SPADI

  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.

  Change from baseline shoulder functionality, at the 4th week and at the 6th week.

• VAS

  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

  Change will be assessed about pain, at the 4th week and at the 6th week from baseline

Study Arms (3)

Active Comparator: Low density ESWT Application

EXPERIMENTAL

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

Device: Extracorporeal Shock Wave Therapy; Other: Placebo ESWT

Active Comparator: High density ESWT Application

EXPERIMENTAL

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

Device: Extracorporeal Shock Wave Therapy; Other: Placebo ESWT

Control

SHAM COMPARATOR

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

Interventions

Extracorporeal Shock Wave Therapy 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

Active Comparator: High density ESWT Application; Active Comparator: Low density ESWT Application

Placebo ESWT 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; Active Comparator: Low density ESWT Application; Control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Okan University: lead
• Medipol University: collaborator

Study Sites (1)

Istanbul Okan University Hospital

Istanbul, Tuzla, 34949, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis; Diabetes Mellitus

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 14, 2017
• Study Start: January 25, 2019
• Primary Completion: September 15, 2019
• Study Completion: September 17, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)