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Shockwave Therapy Effectiveness (ESWT_AC_DM)

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ClinicalTrials.gov Identifier: NCT05214547
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : March 31, 2022
Sponsor:
Collaborators:
Okan University
Medipol University
Information provided by (Responsible Party):
Tülay Çevik Saldıran, Bitlis Eren University

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.

Condition or disease Intervention/treatment Phase
Bursitis Diabetes Mellitus Device: Radial Extracorporeal Shock-wave Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medium-energy Shockwave Therapy Effectiveness in the Treatment of Patients With Both Adhesive Capsulitis and Type 2 Diabetes Mellitus
Actual Study Start Date : February 25, 2022
Estimated Primary Completion Date : January 25, 2023
Estimated Study Completion Date : February 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Experimental Group
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
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.

Placebo Comparator: PlaceboGroup
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
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 Measures :
  1. Change from Baseline Shoulder Pain at 4 weeks [ Time Frame: At 4 week ]
    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.

  2. Change from 4 weeks Shoulder Pain at 6 weeks [ Time Frame: At 6 week ]
    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 :
  1. Change from Baseline Range of Motion of Shoulder Joint at 4 weeks [ Time Frame: At 4 weeks ]
    The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.

  2. Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks [ Time Frame: At 6 weeks ]
    The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.

  3. Change from Baseline Shoulder Function at 4 weeks [ Time Frame: 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.

  4. Change from 4 weeks Shoulder Function at 6 weeks [ Time Frame: 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.


Other Outcome Measures:
  1. Change from baseline Shoulder Muscle Tone at 6 weeks [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214547


Contacts
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Contact: Ahmet Akgöl, Ph.D. 6771630 ext +90216 ahmet.akgol@okan.edu.tr

Locations
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Turkey
Istanbul Okan University Hospital Recruiting
Istanbul, Turkey, 34959
Contact: Pelin Yazgan, Professor    6771630 ext +90216    pelyaz@gmail.com   
Sponsors and Collaborators
Bitlis Eren University
Okan University
Medipol University
Investigators
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Study Director: Pelin Yazgan, Professor Istanbul Okan University Hospital
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Responsible Party: Tülay Çevik Saldıran, Assisstant Professor, Bitlis Eren University
ClinicalTrials.gov Identifier: NCT05214547    
Other Study ID Numbers: BEU_SW
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tülay Çevik Saldıran, Bitlis Eren University:
Pain, Shoulder
Shock-wave
Additional relevant MeSH terms:
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Bursitis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Joint Diseases
Musculoskeletal Diseases