- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04867811
Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
April 29, 2021 updated by: Emad Eldin Mohamed, October 6 University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
They were divided randomly into three groups by lottery method.
Group A (n=30) received conventional therapy, group B (n=30) received TENS in addition to conventional therapy, group C received cupping therapy with conventional therapy and group D (n=30) received TENS and cupping therapy plus conventional therapy.
All patients read and signed a consent form before participation in this trial.
This study was approved by the Ethical Committee of the Faculty of Physical Therapy, October 6 University, Egypt.
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 were included in the study while 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 were excluded from this study.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Qaliubia, Egypt
- Bassam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group A
received conventional therapy
|
conventional therapy
|
Experimental: group B
received TENS in addition to conventional therapy
|
conventional therapy
transcutaneous electrical nerve stimulation
|
Experimental: group C
received cupping therapy with conventional therapy
|
conventional therapy
cupping therapy
|
Experimental: group D
TENS and cupping therapy plus conventional therapy
|
conventional therapy
TENS and cupping therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Analog Scale (VAS)
Time Frame: 4 weeks
|
4 weeks
|
Pain-Free Grip Strength
Time Frame: 4 weeks
|
4 weeks
|
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2020
Primary Completion (Actual)
December 20, 2020
Study Completion (Actual)
December 20, 2020
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (Actual)
April 30, 2021
Study Record Updates
Last Update Posted (Actual)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7645
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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