Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESWT
Phonophoresis
Ultrasound
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral epicondylitis, extracorporeal shock wave therapy, ultrasound, phonophoresis
Eligibility Criteria
Inclusion Criteria:
- Aged between 18-65 years
- Pain on the lateral side of the elbow for at least 4 weeks
- Tenderness over the lateral epicondyle
- Positive in at least two of the lateral epicondylitis spesific tests (Cozen test, Maudley test and Mills test)
Exclusion Criteria:
- Be younger than 18
- Having had ESWT treatment in the elbow area before
- History of injection, surgery, physical therapy in the elbow area in the last 3 months
- Previous elbow surgery
- History of radius/ulna fracture
- A history of cervical and shoulder problems
- having bilateral symptoms
- concomitant medial epicondylitis
- Malignancy
- Pregnancy
- Systemic rheumatologic disease or systemic infection
- inserted cardiac pacemaker
- presence of coagulation disorders
- Cognitive disfunction
Sites / Locations
- Bezmialem Vakif university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
Experimental: ESWT(Extracorporeal Shock Wave Therapy)
Phonophoresis
Ultrasound therapy
Control goup
Arm Description
Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program
Group 2 ( n=17) will be given five times a week, total 10 sessions of diclofenac phonophoresis + home exercise program
Group 2 (n=17) will be given five times a week, total 10 sessions of ultrasound therapy+ home exercise program
Group 4 ( n=17) will be given home exercise program
Outcomes
Primary Outcome Measures
Visual Analog Scale
The self-evaluation of pain severity during rest, activity,night and with palpation was calculated using a 10-cm VAS scale
Secondary Outcome Measures
Patient-Rated Tennis Elbow Evaluation (PRTEE) scales
The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score
The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness
Roles and Maudsley Score
The Roles and Maudsley score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, 2 points = good, 3 points = fair and 4 points = poor.
Health Assessment Questionnaire (HAQ) score
This is a self-reported questionnaire covering 20 items in eight domains related to measuring difficulty in performing activities of daily living: dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities
Grip Strength score
Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer
Full Information
NCT ID
NCT05334953
First Posted
March 31, 2022
Last Updated
January 8, 2023
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT05334953
Brief Title
Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis
Official Title
Comparing the Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
January 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study; to determine the effectiveness of ESWT, ultrasound and phonophoresis treatments on pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments to each other.
Detailed Description
Lateral epicondylitis is the most common cause of elbow lateral pain in adults. Pain that occurs in LE and radiates to the humerus and forearm is characteristic of this disease. The main complaints being pain and decreased grip strength, both of which may affect activities of daily living. The patient's complaints regress with rest,but but can increase again during daily activities such as grasping, repetitive hand movements, holding door handles, turning keys, lifting heavy loads. Diagnosis of lateral epicondylitis is largely based on clinical history and examination. Conservative treatment is the first line treatment. Generally, %90 of patients with LE benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity modification, topical and oral NSAIDs, splinting, stretching and strengthening exercises, various injections, prolotherapy and electrotherapy modalities. Laser, TENS, ultrasound, phonophoresis, iontophoresis and ESWT are electrotherapeutic agents that can be used in therapy to relieve pain and promote healing. Research on physical treatments for LE has not yet proven superiority of one specific approach.
Although many studies have been done for ESWT, ultrasound and phonophoresis, there is not any study that compares these three modalities.In addition, there ara fewer studies about measuring the effect of these treatment methods which contain control groups. In this study, our aim is to investigate the efficacy of ESWT, ultrasound therapy and phonophoresis methods used in the treatment of LE and to compare the efficacy of these three treatments against each other and control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
lateral epicondylitis, extracorporeal shock wave therapy, ultrasound, phonophoresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: ESWT(Extracorporeal Shock Wave Therapy)
Arm Type
Experimental
Arm Description
Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program
Arm Title
Phonophoresis
Arm Type
Experimental
Arm Description
Group 2 ( n=17) will be given five times a week, total 10 sessions of diclofenac phonophoresis + home exercise program
Arm Title
Ultrasound therapy
Arm Type
Experimental
Arm Description
Group 2 (n=17) will be given five times a week, total 10 sessions of ultrasound therapy+ home exercise program
Arm Title
Control goup
Arm Type
Other
Arm Description
Group 4 ( n=17) will be given home exercise program
Intervention Type
Device
Intervention Name(s)
ESWT
Intervention Description
Group 1 (n = 17) will be given two times a week, total 5 sessions of ESWT + home exercise program
Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises
Intervention Type
Device
Intervention Name(s)
Phonophoresis
Intervention Description
Group 2 ( n=17) will be given five times a week total 10 sessions of diclofenac phonophoresis + home exercise program
Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Group 3 (n=17) will be given five times a week total 10 sessions of ultrasound therapy+ home exercise program
Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Other: Home Workout Program Patients will be given eccentric exercises and stretching exercises
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
The self-evaluation of pain severity during rest, activity,night and with palpation was calculated using a 10-cm VAS scale
Time Frame
Change from Baseline at 1 month after treatment.
Secondary Outcome Measure Information:
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE) scales
Description
The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis
Time Frame
Change from Baseline at 1 month after treatment.
Title
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score
Description
The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness
Time Frame
Change from Baseline at 1 month after treatment.
Title
Roles and Maudsley Score
Description
The Roles and Maudsley score was used to evaluate pain and activity limitation as classified in four categories: 1 point = excellent, 2 points = good, 3 points = fair and 4 points = poor.
Time Frame
Change from Baseline at 1 month after treatment.
Title
Health Assessment Questionnaire (HAQ) score
Description
This is a self-reported questionnaire covering 20 items in eight domains related to measuring difficulty in performing activities of daily living: dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities
Time Frame
Change from Baseline at 1 month after treatment.
Title
Grip Strength score
Description
Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer
Time Frame
Change from Baseline at 1 month after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged between 18-65 years
Pain on the lateral side of the elbow for at least 4 weeks
Tenderness over the lateral epicondyle
Positive in at least two of the lateral epicondylitis spesific tests (Cozen test, Maudley test and Mills test)
Exclusion Criteria:
Be younger than 18
Having had ESWT treatment in the elbow area before
History of injection, surgery, physical therapy in the elbow area in the last 3 months
Previous elbow surgery
History of radius/ulna fracture
A history of cervical and shoulder problems
having bilateral symptoms
concomitant medial epicondylitis
Malignancy
Pregnancy
Systemic rheumatologic disease or systemic infection
inserted cardiac pacemaker
presence of coagulation disorders
Cognitive disfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Okan Küçükakkaş, Doç
Organizational Affiliation
okan4494@yahoo.com
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elif Uğurlu, MD
Organizational Affiliation
elifdemirbag92qgmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif university
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30497658
Citation
Yalvac B, Mesci N, Geler Kulcu D, Yurdakul OV. Comparison of ultrasound and extracorporeal shock wave therapy in lateral epicondylosis. Acta Orthop Traumatol Turc. 2018 Sep;52(5):357-362. doi: 10.1016/j.aott.2018.06.004. Epub 2018 Jun 28.
Results Reference
background
PubMed Identifier
28058299
Citation
Bayram K, Yesil H, Dogan E. Efficacy of extracorporeal shock wave therapy in the treatment of lateral epicondylitis. North Clin Istanb. 2014 Aug 3;1(1):33-38. doi: 10.14744/nci.2014.77487. eCollection 2014.
Results Reference
background
PubMed Identifier
15562158
Citation
Stasinopoulos D, Johnson MI. Cyriax physiotherapy for tennis elbow/lateral epicondylitis. Br J Sports Med. 2004 Dec;38(6):675-7. doi: 10.1136/bjsm.2004.013573.
Results Reference
background
PubMed Identifier
26303397
Citation
Weber C, Thai V, Neuheuser K, Groover K, Christ O. Efficacy of physical therapy for the treatment of lateral epicondylitis: a meta-analysis. BMC Musculoskelet Disord. 2015 Aug 25;16:223. doi: 10.1186/s12891-015-0665-4.
Results Reference
background
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Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis
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