NCT05158985

Brief Summary

Lateral epicondylitis is a tendinopathy injury involving the extensor muscles of the forearm. These muscles originate on the lateral epicondylar region of the distal humerus. the insertion of the extensor carpi radialis brevis is involved in most cases. Transdermal administration of an anti-inflammatory drug to specific area is one of the methods that used to decrease inflammation and increase cell metabolism

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
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

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

May 15, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

2.5 years

First QC Date

November 18, 2021

Last Update Submit

December 1, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual analogue scale for pain intensity measurement

    A VAS is usually a horizontal line, 100 mm in length, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain". The patient marks on the line the point that they feel represents their perception of their current state

    4 weeks

  • Hand grip dynamometer for hand grip measurement

    The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg (0-200 lb). The outer dial registers the result in kg and the inner dial registers the result in lb. It has a peak hold needle which automatically retains the highest reading until the device is reset. The handle easily adjusts to five grip positions from 35-87 mm (1½ - 3¼") in 13 mm (½") increments. Always use the wrist strap to prevent the dynamometer from falling on the floor if accidentally dropped

    4 weeks

Study Arms (4)

group A

EXPERIMENTAL

diclofenac sodium phonophoresis using continuous ultrasound with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes

Other: phonophoresis

group B

EXPERIMENTAL

diclofenac sodium phonophoresis using pulsed US with 1:1 duty cycle with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes

Other: phonophoresis

group C

EXPERIMENTAL

diclofenac sodium phonophoresis using pulsed US with 1:4 duty cycle with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 10 minutes

Other: phonophoresis

group D

EXPERIMENTAL

exercises only in form of (strengthening, stretching and occupational exercises).

Other: exercises

Interventions

treatment

group Agroup Bgroup C

treatment

group D

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both sexes will be involved
  • Duration of the disease is more than 12 weeks.
  • Patient's age ranges from 20 to 40 years

You may not qualify if:

  • Diabetic patients.
  • Hypertension patients.
  • Pregnant women
  • Cardiovascular patients
  • Patients with malunion fractures
  • Patients with cervical Radiclopathy
  • Patients with olecranon bursitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad MOHAMED

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

PhonophoresisExercise

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Principal Investigator

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 15, 2021

Study Start

May 15, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

December 15, 2021

Record last verified: 2021-12

Locations