Frozen ShoulderRCTNCT03185078
Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder
A study testing Extracorporeal Shock Wave Therapy in people with Frozen Shoulder and Diabetes Mellitus, run by Okan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Frozen Shoulder, Diabetes Mellitus
- What is being tested?
- Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2019to 17 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Okan University Hospital
Istanbul, Tuzla, 34949
About this study
Official title: Effect of Different Doses of Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder
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.
Read the 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.
- Conditions
- Frozen Shoulder, Diabetes Mellitus
- Being tested
- Extracorporeal Shock Wave Therapy, Placebo ESWT
- Keywords
- physical therapy, ESWT
- Medical subject headings
- Bursitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
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
Placebo ESWTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Low density ESWT Application | Experimental | ESWT application will be done at energy density of 0.12 mJ/mm2. Receives: Device: Extracorporeal Shock Wave Therapy; Other: Placebo ESWT |
| Active Comparator: High density ESWT Application | Experimental | ESWT application will be done at an energy density of 0.3 mJ/mm2. Receives: Device: Extracorporeal Shock Wave Therapy; Other: Placebo ESWT |
| Control | Sham comparator | 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. Receives: Other: Placebo ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline shoulder functionality, at the 4th week and at the 6th week.
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
Measured: Change will be assessed about pain, at the 4th week and at the 6th week from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start25 Jan 2019
- Primary completion15 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Tülay Çevik, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185078
- Sponsor's protocol ID
- Okan University
- Acronym
- RCT
- Status last verified
- Sep 2019
- First submitted
- 29 May 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder
- ClinicalTrials.gov ID
- NCT03185078
- Acronym / sponsor ID
- RCT / Okan University
- Conditions
- Frozen Shoulder, Diabetes Mellitus
- Keywords
- physical therapy, ESWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Low density ESWT Application | Experimental | Device: Extracorporeal Shock Wave Therapy, Other: Placebo ESWTESWT application will be done at energy density of 0.12 mJ/mm2. |
| Active Comparator: High density ESWT Application | Experimental | Device: Extracorporeal Shock Wave Therapy, Other: Placebo ESWTESWT application will be done at an energy density of 0.3 mJ/mm2. |
| Control | Sham comparator | Other: Placebo ESWTThe 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave TherapyExtracorporeal 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 | Device | Active Comparator: High density ESWT Application, Active Comparator: Low density ESWT Application |
| Placebo ESWTIn 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. | Other | Active Comparator: High density ESWT Application, Active Comparator: Low density ESWT Application, Control |
Primary outcome
SPADI
Time frame: Change from baseline shoulder functionality, at the 4th week and at the 6th week.
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
Time frame: Change will be assessed about pain, at the 4th week and at the 6th week from baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy in people with Frozen Shoulder and Diabetes Mellitus, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPADI (time frame: Change from baseline shoulder functionality, at the 4th week and at the 6th week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.