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

Sponsor

South Valley University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05967923

Collaborator

(none)

Enrollment

Location

Arms

16.4

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients will be divided randomly into 3 groups.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Complications	Radiation: Shock wave therapy Radiation: Low level lazer therapy Other: Routine physical therapy program	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Oct 15, 2023

Anticipated Study Completion Date :

Nov 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group (a) Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program.	Radiation: Shock wave therapy Patients in this group will receive shock wave therapy once a week for four weeks in addition to routine physical therapy program. Other Names: Non Other: Routine physical therapy program Patients in this group will receive only routine physical therapy program three times a week for four weeks.
Experimental: Group (b) Patients in this group will receive low level lazer therapy three times per week for four weeks in addition to routine physical therapy program.	Radiation: Low level lazer therapy 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. Other Names: Non Other: Routine physical therapy program Patients in this group will receive only routine physical therapy program three times a week for four weeks.
Experimental: Group (c) Patients in this group will receive only routine physical therapy program.	Other: Routine physical therapy program Patients in this group will receive only routine physical therapy program three times a week for four weeks.

Arm

Intervention/Treatment

Experimental: Group (a)

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

Radiation: Shock wave therapy

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

Other Names:

Non

Other: Routine physical therapy program

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

Experimental: Group (b)

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

Radiation: Low level lazer therapy

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.

Other Names:

Non

Other: Routine physical therapy program

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

Experimental: Group (c)

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

Other: Routine physical therapy program

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

Outcome Measures

Primary Outcome Measures

Shoulder joint Pain [4 weeks]
By using visual analogue scale
Range of motion of the shoulder [4 weeks]
Range of shoulder internal and external rotation and shoulder flexion

Secondary Outcome Measures

Shoulder and hand disability [4 weeks]
By using quick DASH questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shymaa yussuf abo zaid	Cairo		Egypt

Sponsors and Collaborators

South Valley University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shymaa yussuf abo zaid, Lecturer, South Valley University

ClinicalTrials.gov Identifier:

NCT05967923

Other Study ID Numbers:

P.T- ORTH-06/2023-516

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shymaa yussuf abo zaid, Lecturer, South Valley University

Diabetes

Frozen shoulder

Additional relevant MeSH terms:

Diabetes Complications

Study Results

No Results Posted as of Aug 1, 2023