Shockwave Therapy Effectiveness

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bursitis, Diabetes Mellitus

Intervention / Treatment
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* Device: Radial Extracorporeal Shock-wave Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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. | Device: Radial Extracorporeal Shock-wave Therapy<br>* 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.<br>|
| Placebo Comparator: PlaceboGroup<br>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. | Device: Radial Extracorporeal Shock-wave Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Shoulder, Shock-wave