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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05084664
Other study ID # 897
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date October 1, 2021

Study information

Verified date October 2021
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

hey were recruited in the study from October 2020 to September 2021 and allocated randomly into two groups. Group A received premodulated current in addition to exercises, and group B received diadynamic current with the same exercises. Each patient signed the informed consent form approved by the faculty of physical therapy, October 6 university, Egypt and prospectively registered (Clinical Trials.gov, Identifier NCT03338283). Patients was selected according to the following criteria. Inclusive criteria - 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 - no previous physiotherapy interventions. Exclusive criteria Internal or external fixation - arthritis of elbow - contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Internal or external fixation - arthritis of elbow - contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
electrical stimulation
premodulated current+ exercises
electrical stimulation
diadynamic current+ exercises

Locations

Country Name City State
Egypt Bassam Qaliubia

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary baseline hydraulic hand dynamometer grip strength measurement (200 lb.90 kg Capacity) 6 weeks
Primary 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
Primary baseline hydraulic pinch gauge pinch measurement (50 lb.22.5 kg Capacity) 6 weeks
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