- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06568796
Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracorporeal Shoch Wave Therapy of the Patients With Lateral Epicondylitis: a Randomized Controlled Trial
Comparison of the Effects of Trigger Point Ischemic Compression Massage and Focused Extracarporeal Shock Wave Therapy on Pain Level, Muscle Strength, Joint Range of Motion, Functionality and Quality of Life in Patients With Lateral Epicondylitis: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was planned to include at least 66 patients who presented to the sports medicine clinic of Gülhane Training and Research Hospital with lateral epicondyle pain for at least 2 months, were diagnosed with lateral epicondylitis and verbally and in writing declared that they were willing to participate in the study.
Patients participating in the study;
- assessment of pain intensity with visual analog scale (VAS)
- Evaluation of hand grip strength with jamar hand dynamometer
- Isokinetic muscle strength assessment of wrist muscles with biodex isokinetic system 3
- assessment of wrist range of motion with a manual goniometer
- Function assessment with PRTEE-T
- DASH questionnaire
- SF-36 quality of life assessment will be performed before and after treatment.
inclusion criteria
- Male and female individuals aged 18-60 years
- being diagnosed with lateral epicondilitis
- volunteering to participate in the study
exclusion criteria from eswt treatment
- non-cooperation
- presence of systemic and metabolic diseases
- malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
- pregnancy
- utilization of another treatment for lateral epicondylitis during the study period
- previous invasive treatment with steroids for lateral epicondylitis
- any treatment for lateral epicondylitis in the last 6 months
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06010
- Gülhane Eğitim ve Araştırma Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female individuals between the ages of 18-60
- being diagnosed with lateral epicondylitis
- volunteering to participate in the study
Exclusion Criteria:
- non-cooperation
- presence of systemic and metabolic diseases
- malignancy, osteoporosis, fracture, blood clotting disorder, pacemaker, infection
- pregnancy
- utilization of another treatment for lateral epicondylitis during the study period
- previous invasive treatment with steroids for lateral epicondylitis
- any treatment for lateral epicondylitis in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Focused Ekstracorporeal Shoch Wave Theraphy and Exercise
Individuals will be administered focused ekstracorporeal shoch wave theraphy 1 day a week for 4 weeks.
Individuals will exercise every day
|
eswt treatment
|
|
Experimental: Trigger Point Ischemic Compression Massage and Exercise
Individuals will receive trigger point ischemic compression massage 2 days a week for 4 weeks.
Individuals will exercise every day
|
eswt treatment
|
|
No Intervention: Exercise
Individuals will only exercise every day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
grip strenght asessment with jamar hand dynamometer
Time Frame: baseline-up to 4 weeks
|
It will be grip strength assessment with jamar hand dynamometer
|
baseline-up to 4 weeks
|
|
muscle strenght asessment with isocinetic system
Time Frame: baseline-up to 4 weeks
|
It will be elbow flexor and extansor muscle strength asessment with isocinetic system
|
baseline-up to 4 weeks
|
|
range of motion asessment with universal goniometer
Time Frame: baseline-up to 4 weeks
|
It will be elbow range of motion asessment with universal goniometer
|
baseline-up to 4 weeks
|
|
assessment of quality of life with quality of life questionnaire
Time Frame: baseline-up to 4 weeks
|
It will be asessment of quality of life with life questionnaire
|
baseline-up to 4 weeks
|
|
pain level asessment with visual analog scale
Time Frame: baseline-up to 4 weeks
|
It will be asessment of pain level with visual analog scale
|
baseline-up to 4 weeks
|
|
assessment of functionality with functionality questionnaire
Time Frame: baseline-up to 4 weeks
|
It will be asessment of functionality with functionality questionnaire
|
baseline-up to 4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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