NCT04867811

Brief Summary

One hundred and twenty patients (67 females and 53 males) with unilateral TE were included in the study from January 2020 to December 2020 and diagnosed by an orthopedist. Their ages ranged between 20 and 50 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

January 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

April 29, 2021

Last Update Submit

April 29, 2021

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS)

    4 weeks

  • Pain-Free Grip Strength

    4 weeks

  • Patient-Rated Tennis Elbow Evaluation (PRTEE)

    4 weeks

Study Arms (4)

group A

EXPERIMENTAL

received conventional therapy

Other: conventional therapy

group B

EXPERIMENTAL

received TENS in addition to conventional therapy

Other: conventional therapyDevice: TENS

group C

EXPERIMENTAL

received cupping therapy with conventional therapy

Other: conventional therapyOther: cupping therapy

group D

EXPERIMENTAL

TENS and cupping therapy plus conventional therapy

Other: conventional therapyOther: TENS and cupping therapy

Interventions

conventional therapyOTHER

conventional therapy

group Agroup Bgroup Cgroup D
cupping therapyOTHER

cupping therapy

group C
TENSDEVICE

transcutaneous electrical nerve stimulation

group B
TENS and cupping therapyOTHER

TENS and cupping therapy

group D

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months

You may not qualify if:

  • patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassam

Qaliubia, Egypt

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Cupping TherapyTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

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

Study Record Dates

First Submitted

April 29, 2021

First Posted

April 30, 2021

Study Start

January 12, 2020

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)