Diabetes ComplicationsNCT05967923
Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic Frozen Shoulder Patients.
A study testing Shock wave therapy, Low level lazer therapy and Routine physical therapy program in people with Diabetes Complications, run by South Valley University at 1 site in Egypt.
Trial summary
Patients will be divided randomly into 3 groups. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- Shock wave therapy, Low level lazer therapy and Routine physical therapy program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2023to 15 Nov 2024
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with diabetes mellitus.
- patients with frozen shoulder due to diabetes mellitus.
- patients age ranged between 45 and 60 years old.
- cooperative patients.
Who cannot join
- patients with un-controlled hypertension.
- patients sensetive to shock wave or lazer irradiation.
- Patients with infectious skin diseases.
- un-cooperative patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Shymaa yussuf abo zaid
Cairo
Shymaa Y Abo zaid, 01010941685 ext. 01091631018, shaymaayoussef397@gmail.com
Shymaa Y Abo zaid, Doctoral
About this study
Official title: Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic
Patients will be divided randomly into 3 groups.
Read the detailed description
Patients will be allocated from out patient clinics of Qena university hospitals Then they will be randomly assigned to three groups, every one will contain 30 patients of both gender, with age range between 45 and 60 years old
- Conditions
- Diabetes Complications
- Being tested
- Shock wave therapy, Low level lazer therapy, Routine physical therapy program
- Keywords
- Diabetes, Frozen shoulder
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock wave therapyRadiation
Also called Non
Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.
Low level lazer therapyRadiation
Also called Non
Patients in this group will receive low level lazer therapy three times a week week for four weeks in addition to routine physical therapy program.
Routine physical therapy programOther
Patients in this group will receive only routine physical therapy program three times a week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group (a) | Experimental | Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program. Receives: Radiation: Shock wave therapy; Other: Routine physical therapy program |
| Group (b) | Experimental | Patients in this group will receive low level lazer therapy three times per week for four weeks in addition to routine physical therapy program. Receives: Radiation: Low level lazer therapy; Other: Routine physical therapy program |
| Group (c) | Experimental | Patients in this group will receive only routine physical therapy program. Receives: Other: Routine physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder joint Pain
By using visual analogue scale
Measured: 4 weeks
Range of motion of the shoulder
Range of shoulder internal and external rotation and shoulder flexion
Measured: 4 weeks
Secondary outcomes (1)
Shoulder and hand disability
By using quick DASH questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start5 Jul 2023
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies 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
- Model description
- Group (a) Group (b) Group (c)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa yussuf abo zaid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967923
- Sponsor's protocol ID
- P.T- ORTH-06/2023-516
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 1 Aug 2023
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic
- ClinicalTrials.gov ID
- NCT05967923
- Acronym / sponsor ID
- P.T- ORTH-06/2023-516
- Conditions
- Diabetes Complications
- Keywords
- Diabetes, Frozen shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 1 Aug 2023 (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.
Patients will be divided randomly into 3 groups.
Detailed description
Patients will be allocated from out patient clinics of Qena university hospitals Then they will be randomly assigned to three groups, every one will contain 30 patients of both gender, with age range between 45 and 60 years old
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group (a) Group (b) Group (c)
| Arm | Type | Receives |
|---|---|---|
| Group (a) | Experimental | Radiation: Shock wave therapy, Other: Routine physical therapy programPatients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program. |
| Group (b) | Experimental | Radiation: Low level lazer therapy, Other: Routine physical therapy programPatients in this group will receive low level lazer therapy three times per week for four weeks in addition to routine physical therapy program. |
| Group (c) | Experimental | Other: Routine physical therapy programPatients in this group will receive only routine physical therapy program. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with diabetes mellitus.
- patients with frozen shoulder due to diabetes mellitus.
- patients age ranged between 45 and 60 years old.
- cooperative patients.
Key exclusion criteria (4 listed)
- patients with un-controlled hypertension.
- patients sensetive to shock wave or lazer irradiation.
- Patients with infectious skin diseases.
- un-cooperative patients.
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 |
|---|---|---|
| Shock wave therapyAlso: NonPatients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program. | Radiation | Group (a) |
| Low level lazer therapyAlso: NonPatients in this group will receive low level lazer therapy three times a week week for four weeks in addition to routine physical therapy program. | Radiation | Group (b) |
| Routine physical therapy programPatients in this group will receive only routine physical therapy program three times a week for four weeks. | Other | Group (a), Group (b), Group (c) |
Primary outcome
Shoulder joint Pain
Time frame: 4 weeks
By using visual analogue scale
Range of motion of the shoulder
Time frame: 4 weeks
Range of shoulder internal and external rotation and shoulder flexion
1 secondary outcome
Shoulder and hand disability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock wave therapy, Low level lazer therapy and Routine physical therapy program in people with Diabetes Complications, run by South Valley University at 1 site in Egypt.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 Egypt. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shymaa Yussuf Abo zaid (01010941685 ext. 01091631018, shaymaayoussef397@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder joint Pain (time frame: 4 weeks). 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 1 Aug 2023.