Back to resultsEffectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rESWT
Supervised exercises
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis
Eligibility Criteria
Inclusion Criteria:
- The diagnosis of LE was made in the clinical examination, and the diagnosis was confirmed with the Southampton Diagnostic Criteria of "the presence of epicondyle pain, and epicondyle pain and tenderness on resisted extension of the wrist.
- Patients with symptoms lasting longer than 3 months
- with average pain in the previous week detected as 3 or above on a 10-cm visual analogue scale (VAS)
- who were aged over 18 years
Exclusion Criteria:
- pain in the proximal part of the affected extremity (e.g. shoulder pain, neck pain)
- abnormal neurogenic symptoms (e.g. radicular pain, numbness) on the affected extremity
- presence of posterior interosseous nerve entrapment
- congenital or acquired upper extremity deformities that might affect grip strength
- systemic musculoskeletal system or neurologic disorders
- systemic rheumatologic disease or systemic infection
- presence of malignancy, coagulation disorders, and anticoagulant use
- inserted cardiac pacemaker
- history of surgical treatment on the elbow of the affected extremity
- pregnancy.
- patients who were administered other treatments such as physical therapy or steroid injections in the last 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
rESWT
supervised exercises
Arm Description
the group receiving rESWT
the group receiving supervised exercises
Outcomes
Primary Outcome Measures
Change Patient-rated Tennis Elbow Evaluation score
The Patient-rated Tennis Elbow Evaluation is a specific questionnaire designed for the evaluation of the disease-specific pain and function/disability in LE. The scores were calculated separately and as the total PRTEE score, where 0 represented the best score, and 100 represented the worst score. The PRTEE consists of a pain scale with 5 items questioning pain during rest and specific activities (0 represents 'no pain' and 10 represents 'the highest pain'), and a function/disability scale with 10 items evaluating difficulties experienced during specific and daily activities (0 represents 'no difficulty' and 10 represents 'the highest difficulty)
Secondary Outcome Measures
Change Visual Analogue Scale score
The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale
Change 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, "no pain, complete movement, and complete activity;" 2 points = good, "discomfort from time to time, complete movement, and complete activity;" 3 points = fair, "discomfort after long-duration activity;" and 4 points = poor, "pain that restricts activity".
Change Grip Strength score
Grip strength of the affected upper extremity was calculated using a Hydraulic Hand Dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03834090
Brief Title
Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis
Official Title
Comparison of the Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2015 (Actual)
Primary Completion Date
August 15, 2015 (Actual)
Study Completion Date
January 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
No consensus has yet been built on the treatment of lateral epicondylitis (LE) due to the lack of evidence. Although conflicting results are present, radial extracorporeal shock wave therapy (rESWT) has increasingly been used in the treatment of tendinopathy
Detailed Description
ESWT and exercise have beneficial effects on the management of tendinopathies owing to their various mechanisms that showed therapeutic efficacy. Owing to its positive outcomes, extracorporeal shock wave therapy (ESWT) has recently been used in the treatment of musculoskeletal system diseases such as plantar fasciitis, Achilles tendinopathy, calcific rotator cuff tendinopathies, and patellar tendinopathy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rESWT
Arm Type
Experimental
Arm Description
the group receiving rESWT
Arm Title
supervised exercises
Arm Type
Active Comparator
Arm Description
the group receiving supervised exercises
Intervention Type
Device
Intervention Name(s)
rESWT
Intervention Description
rESWT was administered once per week for 3 weeks using a ShockMaster 500 device with 1.8 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses.
Intervention Type
Other
Intervention Name(s)
Supervised exercises
Intervention Description
A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors
Primary Outcome Measure Information:
Title
Change Patient-rated Tennis Elbow Evaluation score
Description
The Patient-rated Tennis Elbow Evaluation is a specific questionnaire designed for the evaluation of the disease-specific pain and function/disability in LE. The scores were calculated separately and as the total PRTEE score, where 0 represented the best score, and 100 represented the worst score. The PRTEE consists of a pain scale with 5 items questioning pain during rest and specific activities (0 represents 'no pain' and 10 represents 'the highest pain'), and a function/disability scale with 10 items evaluating difficulties experienced during specific and daily activities (0 represents 'no difficulty' and 10 represents 'the highest difficulty)
Time Frame
Change from Baseline at 1 month and 3 months after treatment.
Secondary Outcome Measure Information:
Title
Change Visual Analogue Scale score
Description
The self-evaluation of pain severity during rest and activity in the previous week was calculated using a 10-cm VAS scale
Time Frame
Change from Baseline at 1 month and 3 months after treatment.
Title
Change 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, "no pain, complete movement, and complete activity;" 2 points = good, "discomfort from time to time, complete movement, and complete activity;" 3 points = fair, "discomfort after long-duration activity;" and 4 points = poor, "pain that restricts activity".
Time Frame
Change from Baseline at 1 month and 3 months after treatment.
Title
Change 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 and 3 months after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosis of LE was made in the clinical examination, and the diagnosis was confirmed with the Southampton Diagnostic Criteria of "the presence of epicondyle pain, and epicondyle pain and tenderness on resisted extension of the wrist.
Patients with symptoms lasting longer than 3 months
with average pain in the previous week detected as 3 or above on a 10-cm visual analogue scale (VAS)
who were aged over 18 years
Exclusion Criteria:
pain in the proximal part of the affected extremity (e.g. shoulder pain, neck pain)
abnormal neurogenic symptoms (e.g. radicular pain, numbness) on the affected extremity
presence of posterior interosseous nerve entrapment
congenital or acquired upper extremity deformities that might affect grip strength
systemic musculoskeletal system or neurologic disorders
systemic rheumatologic disease or systemic infection
presence of malignancy, coagulation disorders, and anticoagulant use
inserted cardiac pacemaker
history of surgical treatment on the elbow of the affected extremity
pregnancy.
patients who were administered other treatments such as physical therapy or steroid injections in the last 3 months
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis
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