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Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic Frozen Shoulder Patients.

Primary Purpose

Diabetes Complications

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Shock wave therapy

Low level lazer therapy

Routine physical therapy program

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring Diabetes, Frozen shoulder

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with diabetes mellitus. patients with frozen shoulder due to diabetes mellitus. patients age ranged between 45 and 60 years old. cooperative patients. Exclusion Criteria: patients with un-controlled hypertension. patients sensetive to shock wave or lazer irradiation. Patients with infectious skin diseases. un-cooperative patients.

Sites / Locations

Shymaa yussuf abo zaidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group (a)

Group (b)

Group (c)

Arm Description

Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.

Patients in this group will receive low level lazer therapy three times per week for four weeks in addition to routine physical therapy program.

Patients in this group will receive only routine physical therapy program.

Outcomes

Primary Outcome Measures

Shoulder joint Pain

By using visual analogue scale

Range of motion of the shoulder

Range of shoulder internal and external rotation and shoulder flexion

Secondary Outcome Measures

Shoulder and hand disability

By using quick DASH questionnaire

Full Information

NCT ID

NCT05967923

First Posted

July 15, 2023

Last Updated

July 22, 2023

Sponsor

South Valley University

1. Study Identification

Unique Protocol Identification Number

NCT05967923

Brief Title

Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic Frozen Shoulder Patients.

Official Title

Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 5, 2023 (Actual)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Complications

Keywords

Diabetes, Frozen shoulder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Group (a) Group (b) Group (c)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group (a)

Arm Type

Experimental

Arm Description

Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.

Arm Title

Group (b)

Arm Type

Experimental

Arm Description

Patients in this group will receive low level lazer therapy three times per week for four weeks in addition to routine physical therapy program.

Arm Title

Group (c)

Arm Type

Experimental

Arm Description

Patients in this group will receive only routine physical therapy program.

Intervention Type

Radiation

Intervention Name(s)

Shock wave therapy

Other Intervention Name(s)

Non

Intervention Description

Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.

Intervention Type

Radiation

Intervention Name(s)

Low level lazer therapy

Other Intervention Name(s)

Non

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Routine physical therapy program

Intervention Description

Patients in this group will receive only routine physical therapy program three times a week for four weeks.

Primary Outcome Measure Information:

Title

Shoulder joint Pain

Description

By using visual analogue scale

Time Frame

4 weeks

Title

Range of motion of the shoulder

Description

Range of shoulder internal and external rotation and shoulder flexion

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Shoulder and hand disability

Description

By using quick DASH questionnaire

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shymaa Yussuf Abo zaid

Phone

01010941685

Ext

01091631018

shaymaayoussef397@gmail.com

Facility Information:

Facility Name

Shymaa yussuf abo zaid

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shymaa Y Abo zaid

Phone

01010941685

Ext

01091631018

shaymaayoussef397@gmail.com

First Name & Middle Initial & Last Name & Degree

Shymaa Y Abo zaid, Doctoral

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effectiveness of Shock Wave Therapy Versus Low Level Lazer Therapy in Diabetic Frozen Shoulder Patients.

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