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Shockwave Therapy Effectiveness (ESWT_AC_DM)

Primary Purpose

Bursitis, Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Radial Extracorporeal Shock-wave Therapy
Sponsored by
Bitlis Eren University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bursitis focused on measuring Pain, Shoulder, Shock-wave

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged > 18 years
  • Unilateral adhesive capsulitis of the shoulder
  • The symptom duration > 3 months
  • Shoulder pain
  • The Limited glenohumeral joint active range of motion of greater than 50% in at least three specific movements among abduction, flexion, internal rotation, and external rotation
  • Having type 2 diabetes for at least 3 years

Exclusion Criteria:

  • Previous shoulder surgeries
  • Massive, minor, and major rotator cuff tears
  • Pain and muscle strength loss due to neurological causes
  • History or presence of malignancy
  • Osteoporosis

Sites / Locations

  • Istanbul Okan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

PlaceboGroup

Arm Description

The patients received shock-wave exposure (energy flux density= 0.12 mJ/mm2, at 8 Hz), twice a week, for six weeks. Standard physiotherapy care was applied.

In the placebo group, the device applicator was positioned in the same way as the experimental shock-wave group. The previously recorded 8 Hz pulsed shock wave sounds were played, as if the actual application was being performed, however the device itself was off during the session, and its pedal was not pressed. Standard physiotherapy care was applied.

Outcomes

Primary Outcome Measures

Change from Baseline Shoulder Pain at 4 weeks
Evaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" on the far left and "the most intense pain imaginable" on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.
Change from 4 weeks Shoulder Pain at 6 weeks
Evaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" on the far left and "the most intense pain imaginable" on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.

Secondary Outcome Measures

Change from Baseline Range of Motion of Shoulder Joint at 4 weeks
The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.
Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks
The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.
Change from Baseline Shoulder Function at 4 weeks
Function was assessed using the self-administered Shoulder Pain and Disability Index.The Shoulder Pain and Disability Index contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, higher score indicating greater impairment or disability.
Change from 4 weeks Shoulder Function at 6 weeks
Function was assessed using the self-administered Shoulder Pain and Disability Index.The Shoulder Pain and Disability Index contains 13 items that assess two domains; a 5-item sub-scale that measures pain and an 8-item sub-scale that measures disability. Each sub-scale is summed and transformed to a score out of 100. A mean is taken of the two sub-scales to give a total score out of 100, higher score indicating greater impairment or disability.

Full Information

First Posted
January 14, 2022
Last Updated
March 17, 2022
Sponsor
Bitlis Eren University
Collaborators
Okan University, Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05214547
Brief Title
Shockwave Therapy Effectiveness
Acronym
ESWT_AC_DM
Official Title
Medium-energy Shockwave Therapy Effectiveness in the Treatment of Patients With Both Adhesive Capsulitis and Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
January 25, 2023 (Anticipated)
Study Completion Date
February 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bitlis Eren University
Collaborators
Okan University, 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
Our hypothesis is that shock-wave therapy will reduce pain, increase the mobilization of glenohumeral joint, and will improve functionality in patients with adhesive capsulitis and type 2 diabetes mellitus.
Detailed Description
The underlying mechanism of shock-wave therapy in individuals with both adhesive capsulitis and type 2 diabetes mellitus still remains unclear. Considering the physiological mechanism of shock-wave therapy, the effect of shock-wave therapy on pain, function, and resting muscle tone in patients with adhesive capsulitis and type 2 diabetes mellitus was evaluated. There are only two studies that evaluated the usefulness of shock-wave therapy in diabetic patients. There are no studies examining the effect of shock-wave therapy on shoulder muscle tone in individuals with adhesive capsulitis and type 2 diabetes mellitus. Therefore, the aim of this study is to investigate the treatment effects of mrESWT, in individuals with adhesive capsulitis and type 2 diabetes mellitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bursitis, Diabetes Mellitus
Keywords
Pain, Shoulder, Shock-wave

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The patients received shock-wave exposure (energy flux density= 0.12 mJ/mm2, at 8 Hz), twice a week, for six weeks. Standard physiotherapy care was applied.
Arm Title
PlaceboGroup
Arm Type
Placebo Comparator
Arm Description
In the placebo group, the device applicator was positioned in the same way as the experimental shock-wave group. The previously recorded 8 Hz pulsed shock wave sounds were played, as if the actual application was being performed, however the device itself was off during the session, and its pedal was not pressed. Standard physiotherapy care was applied.
Intervention Type
Device
Intervention Name(s)
Radial Extracorporeal Shock-wave Therapy
Intervention Description
Radial Extracorporeal Shock Wave Therapy, also called radial pulse therapy. In contrast to regular focused shock wave therapy,Radial Extracorporeal Shock Wave Therapy creates a diverging pressure field, which reaches a maximal pressure already at the source, and therefore has a more superficial, but broader, effect than focused shock wave therapy. This treatment is increasingly used for calcific and non-calcific tendinopathy, probably because it is easier to apply and more affordable than focused shock wave therapy. The proposed mechanisms for the effect of Radial Extracorporeal Shock Wave Therapy include pain relief, tissue regeneration and destruction of calcification.
Primary Outcome Measure Information:
Title
Change from Baseline Shoulder Pain at 4 weeks
Description
Evaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" on the far left and "the most intense pain imaginable" on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.
Time Frame
At 4 week
Title
Change from 4 weeks Shoulder Pain at 6 weeks
Description
Evaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" on the far left and "the most intense pain imaginable" on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.
Time Frame
At 6 week
Secondary Outcome Measure Information:
Title
Change from Baseline Range of Motion of Shoulder Joint at 4 weeks
Description
The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.
Time Frame
At 4 weeks
Title
Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks
Description
The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.
Time Frame
At 6 weeks
Title
Change from Baseline Shoulder Function at 4 weeks
Description
Function was assessed using the self-administered Shoulder Pain and Disability Index.The Shoulder Pain and Disability Index contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, higher score indicating greater impairment or disability.
Time Frame
At 4 weeks
Title
Change from 4 weeks Shoulder Function at 6 weeks
Description
Function was assessed using the self-administered Shoulder Pain and Disability Index.The Shoulder Pain and Disability Index contains 13 items that assess two domains; a 5-item sub-scale that measures pain and an 8-item sub-scale that measures disability. Each sub-scale is summed and transformed to a score out of 100. A mean is taken of the two sub-scales to give a total score out of 100, higher score indicating greater impairment or disability.
Time Frame
At 6 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline Shoulder Muscle Tone at 6 weeks
Description
The muscle tone which is a biomechanical property of the shoulder muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the muscle tone of forearm muscles measurements will be performed and recorded.
Time Frame
At 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged > 18 years Unilateral adhesive capsulitis of the shoulder The symptom duration > 3 months Shoulder pain The Limited glenohumeral joint active range of motion of greater than 50% in at least three specific movements among abduction, flexion, internal rotation, and external rotation Having type 2 diabetes for at least 3 years Exclusion Criteria: Previous shoulder surgeries Massive, minor, and major rotator cuff tears Pain and muscle strength loss due to neurological causes History or presence of malignancy Osteoporosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet Akgöl, Ph.D.
Phone
6771630
Ext
+90216
Email
ahmet.akgol@okan.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pelin Yazgan, Professor
Organizational Affiliation
Istanbul Okan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Okan University Hospital
City
Istanbul
ZIP/Postal Code
34959
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pelin Yazgan, Professor
Phone
6771630
Ext
+90216
Email
pelyaz@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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