Shockwave Therapy Effectiveness

Diabetes Mellitus Clinical Trial

— ESWT_AC_DM  

Official title:

Medium-energy Shockwave Therapy Effectiveness in the Treatment of Patients With Both Adhesive Capsulitis and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214547
• Other study ID #: BEU_SW
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: February 25, 2023

Study information

• Verified date: March 2022
• Source: Bitlis Eren University
• Contact: Ahmet Akgöl, Ph.D.
• Phone: 6771630
• Email: ahmet.akgol[@]okan.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Diabetes Mellitus

Intervention

Device:
• Radial Extracorporeal Shock-wave Therapy
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.

Locations

Country	Name	City	State
Turkey	Istanbul Okan University Hospital	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Bitlis Eren University	Medipol University, Okan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Shoulder Muscle Tone at 6 weeks	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.	At 6 weeks
Primary	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.	At 4 week
Primary	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.	At 6 week
Secondary	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.	At 4 weeks
Secondary	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.	At 6 weeks
Secondary	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.	At 4 weeks
Secondary	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.	At 6 weeks