Back to resultsEffect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
Primary Purpose
Tennis Elbow
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional therapy
cupping therapy
TENS
TENS and cupping therapy
Sponsored by
About this trial
This is an interventional treatment trial for Tennis Elbow
Eligibility Criteria
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
Sites / Locations
- Bassam
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
group A
group B
group C
group D
Arm Description
received conventional therapy
received TENS in addition to conventional therapy
received cupping therapy with conventional therapy
TENS and cupping therapy plus conventional therapy
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
Pain-Free Grip Strength
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04867811
Brief Title
Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
Official Title
Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
received conventional therapy
Arm Title
group B
Arm Type
Experimental
Arm Description
received TENS in addition to conventional therapy
Arm Title
group C
Arm Type
Experimental
Arm Description
received cupping therapy with conventional therapy
Arm Title
group D
Arm Type
Experimental
Arm Description
TENS and cupping therapy plus conventional therapy
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
conventional therapy
Intervention Type
Other
Intervention Name(s)
cupping therapy
Intervention Description
cupping therapy
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
transcutaneous electrical nerve stimulation
Intervention Type
Other
Intervention Name(s)
TENS and cupping therapy
Intervention Description
TENS and cupping therapy
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Time Frame
4 weeks
Title
Pain-Free Grip Strength
Time Frame
4 weeks
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bassam
City
Qaliubia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
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