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

Primary Purpose

Frozen Shoulder, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy
Placebo ESWT
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring physical therapy, ESWT

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Okan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Active Comparator: Low density ESWT Application

Active Comparator: High density ESWT Application

Control

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2017
Last Updated
September 17, 2019
Sponsor
Okan University
Collaborators
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT03185078
Brief Title
Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder
Acronym
RCT
Official Title
Effect of Different Doses of Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University
Collaborators
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder, Diabetes Mellitus
Keywords
physical therapy, ESWT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: Low density ESWT Application
Arm Type
Experimental
Arm Description
ESWT application will be done at energy density of 0.12 mJ/mm2.
Arm Title
Active Comparator: High density ESWT Application
Arm Type
Experimental
Arm Description
ESWT application will be done at an energy density of 0.3 mJ/mm2.
Arm Title
Control
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy
Intervention Description
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
Other
Intervention Name(s)
Placebo ESWT
Intervention Description
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 Measure Information:
Title
SPADI
Description
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.
Time Frame
Change from baseline shoulder functionality, at the 4th week and at the 6th week.
Title
VAS
Description
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
Time Frame
Change will be assessed about pain, at the 4th week and at the 6th week from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Istanbul Okan University Hospital
City
Istanbul
State/Province
Tuzla
ZIP/Postal Code
34949
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder

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