Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.
Primary Purpose
Tennis Elbow
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
electrical stimulation
electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Tennis Elbow
Eligibility Criteria
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.
Sites / Locations
- Bassam
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group A
group B
Arm Description
premodulated current
diadynamic current
Outcomes
Primary Outcome Measures
baseline hydraulic hand dynamometer
grip strength measurement (200 lb.90 kg Capacity)
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)
baseline hydraulic pinch gauge
pinch measurement (50 lb.22.5 kg Capacity)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05084664
Brief Title
Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.
Official Title
Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (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
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.
Detailed 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.
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
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
premodulated current
Arm Title
group B
Arm Type
Experimental
Arm Description
diadynamic current
Intervention Type
Device
Intervention Name(s)
electrical stimulation
Intervention Description
premodulated current+ exercises
Intervention Type
Device
Intervention Name(s)
electrical stimulation
Intervention Description
diadynamic current+ exercises
Primary Outcome Measure Information:
Title
baseline hydraulic hand dynamometer
Description
grip strength measurement (200 lb.90 kg Capacity)
Time Frame
6 weeks
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Description
pain and functional measurement (The maximum score is 50 for the pain subscale and 100 for the function subscale)
Time Frame
6 weeks
Title
baseline hydraulic pinch gauge
Description
pinch measurement (50 lb.22.5 kg Capacity)
Time Frame
6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Bassam
City
Qaliubia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.
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