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

July 22, 2023 updated by: Shymaa yussuf abo zaid, South Valley University

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

Patients will be divided randomly into 3 groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Shymaa yussuf abo zaid
        • Contact:
        • Principal Investigator:
          • Shymaa Y Abo zaid, Doctoral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: Routine physical therapy program
Patients in this group will receive only routine physical therapy program three times a week for four weeks.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder joint Pain
Time Frame: 4 weeks
By using visual analogue scale
4 weeks
Range of motion of the shoulder
Time Frame: 4 weeks
Range of shoulder internal and external rotation and shoulder flexion
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder and hand disability
Time Frame: 4 weeks
By using quick DASH questionnaire
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Estimated)

October 15, 2023

Study Completion (Estimated)

November 15, 2024

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

July 22, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T- ORTH-06/2023-516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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