NCT05967923

Brief Summary

Patients will be divided randomly into 3 groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 15, 2023

Last Update Submit

July 22, 2023

Conditions

Keywords

DiabetesFrozen shoulder

Outcome Measures

Primary Outcomes (2)

  • Shoulder joint Pain

    By using visual analogue scale

    4 weeks

  • Range of motion of the shoulder

    Range of shoulder internal and external rotation and shoulder flexion

    4 weeks

Secondary Outcomes (1)

  • Shoulder and hand disability

    4 weeks

Study Arms (3)

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.

Radiation: Shock wave therapyOther: 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.

Radiation: Low level lazer therapyOther: Routine physical therapy program

Group (c)

EXPERIMENTAL

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

Other: Routine physical therapy program

Interventions

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

Also known as: Non
Group (a)

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.

Also known as: Non
Group (b)

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

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

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with diabetes mellitus.
  • patients with frozen shoulder due to diabetes mellitus.
  • patients age ranged between 45 and 60 years old.
  • cooperative patients.

You may not qualify if:

  • patients with un-controlled hypertension.
  • patients sensetive to shock wave or lazer irradiation.
  • Patients with infectious skin diseases.
  • un-cooperative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shymaa yussuf abo zaid

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes ComplicationsDiabetes MellitusBursitis

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Endocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Shymaa Yussuf Abo zaid

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group (a) Group (b) Group (c)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 15, 2023

First Posted

August 1, 2023

Study Start

July 5, 2023

Primary Completion

October 15, 2023

Study Completion

November 15, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations