NCT05084664

Brief Summary

104 patients with unilateral tennis elbow from both genders (57 females and 43 males) referred by orthopaedist with age ranged between 20 and 60 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

October 15, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

October 6, 2021

Last Update Submit

October 20, 2021

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (3)

  • baseline hydraulic hand dynamometer

    grip strength measurement (200 lb.90 kg Capacity)

    6 weeks

  • Patient-Rated Tennis Elbow Evaluation (PRTEE)

    pain and functional measurement (The maximum score is 50 for the pain subscale and 100 for the function subscale)

    6 weeks

  • baseline hydraulic pinch gauge

    pinch measurement (50 lb.22.5 kg Capacity)

    6 weeks

Study Arms (2)

group A

EXPERIMENTAL

premodulated current

Device: electrical stimulation

group B

EXPERIMENTAL

diadynamic current

Device: electrical stimulation

Interventions

electrical stimulationDEVICE

premodulated current+ exercises

group A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
  • lasting of the symptoms for 3 months
  • previous physiotherapy interventions.

You may not qualify if:

  • Internal or external fixation
  • arthritis of elbow
  • contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassam

Qaliubia, Egypt

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer (header of basic science department)

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 20, 2021

Study Start

October 15, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)