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Short and Long Term Effects of IASTM and ESWT Therapy in Individuals With Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
IASTM
ESWT
Home Exercise
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Lateral epicondylitis, pain, function, grip strength

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: being diagnosed with chronic LET by a physician visual analog scale (VAS) pain score ≥ 3 Exclusion Criteria: any accompanying pathology in the wrist and forearm, such as a fracture or dislocation of the elbow; treatment with corticosteroid injections in the past 6 months

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

IASTM

ESWT

Home Exercise

Arm Description

In addition to the home exercise program application, IASTM application will be made for 4 weeks. IASTM will be applied to the affected extremity twice a week for 4 weeks, in total 8 sessions. Participants will be asked to sit comfortably in a chair with back support. IASTM will be applied to the wrist extensor muscles of the participants for 90 seconds in the position where the muscle is tense, with a frequency of 60 beats per minute (Cheatham et al., 2019). The instruments will be applied to the soft tissue at 30º-60º angles, using vaseline as an intermediate, with a multidirectional "stroking" movement.

ESWT will be applied to the affected elbow two days a week for 4 weeks, a total of 8 sessions, each session 2000 shock 10 Hz frequency, 2.5 bar intensity point and circumferential application. Ultrasound gel will be used as an intermediate in the application. No anesthetic substance will be used before and after the application. Cold applications will be recommended for those who have pain after the application.

Static stretching and eccentric strengthening exercises specific to the forearm muscles will be taught and they will be asked to perform 2 sets (morning-lunch-evening) 10 repetitions per day, 5 days a week, for 4 weeks. For strengthening exercises, all patients will be asked to use green (medium resistance) elastic bands, hold them in a tense position for 10 seconds, let them back passively, and rest for 1 minute between sets. In the stretching exercise, they will be asked to stay in the most tense position for 30-45 seconds and rest for 30 seconds between stretching. In case of a painful situation, they will be asked to be informed about their information.

Outcomes

Primary Outcome Measures

Change from Baseline Pain assessed by Visual Analog Scale.
Pain will be evaluated with Visual Analog Scale. 0 means no pain, 10 means unbearable pain.

Secondary Outcome Measures

Grip strength
Grip strength will be evaluated with Hand Dynamometer
Function assessed by Patient-rated Forearm Evaluation Questionnaire
Function will be evaluated with Patient-rated Forearm Evaluation Questionnaire

Full Information

First Posted
December 28, 2022
Last Updated
March 13, 2023
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT05683275
Brief Title
Short and Long Term Effects of IASTM and ESWT Therapy in Individuals With Lateral Epicondylitis
Official Title
Short and Long Term Effects of Instrument Assisted Soft Tissue Mobilization and Extracorporeal Shock Wave Therapy in Individuals With Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay 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
Pain, decreased grip strength, and loss of function are observed in individuals with lateral epicondylitis. The aim of this study is to investigate the effects of ESWT and IASTM applications on pain, grip strength and function in individuals with lateral epicondylitis.
Detailed Description
The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Participants will be randomly divided into three groups: IASTM, ESWT and home exercise group. In addition to home exercise, IASTM and ESWT groups will be given 2 sessions per week for 4 weeks. Pain, grip strength and functionality of the participants will be evaluated before the application, after 4 weeks of application and 4 weeks after the end of the application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Lateral epicondylitis, pain, function, grip strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IASTM
Arm Type
Experimental
Arm Description
In addition to the home exercise program application, IASTM application will be made for 4 weeks. IASTM will be applied to the affected extremity twice a week for 4 weeks, in total 8 sessions. Participants will be asked to sit comfortably in a chair with back support. IASTM will be applied to the wrist extensor muscles of the participants for 90 seconds in the position where the muscle is tense, with a frequency of 60 beats per minute (Cheatham et al., 2019). The instruments will be applied to the soft tissue at 30º-60º angles, using vaseline as an intermediate, with a multidirectional "stroking" movement.
Arm Title
ESWT
Arm Type
Experimental
Arm Description
ESWT will be applied to the affected elbow two days a week for 4 weeks, a total of 8 sessions, each session 2000 shock 10 Hz frequency, 2.5 bar intensity point and circumferential application. Ultrasound gel will be used as an intermediate in the application. No anesthetic substance will be used before and after the application. Cold applications will be recommended for those who have pain after the application.
Arm Title
Home Exercise
Arm Type
Experimental
Arm Description
Static stretching and eccentric strengthening exercises specific to the forearm muscles will be taught and they will be asked to perform 2 sets (morning-lunch-evening) 10 repetitions per day, 5 days a week, for 4 weeks. For strengthening exercises, all patients will be asked to use green (medium resistance) elastic bands, hold them in a tense position for 10 seconds, let them back passively, and rest for 1 minute between sets. In the stretching exercise, they will be asked to stay in the most tense position for 30-45 seconds and rest for 30 seconds between stretching. In case of a painful situation, they will be asked to be informed about their information.
Intervention Type
Other
Intervention Name(s)
IASTM
Intervention Description
IASTM will be applied to the affected extremity twice a week for 4 weeks, in total 8 sessions. Participants will be asked to sit comfortably in a chair with back support. IASTM will be applied to the wrist extensor muscles of the participants for 90 seconds in the position where the muscle is tense, with a frequency of 60 beats per minute.
Intervention Type
Other
Intervention Name(s)
ESWT
Intervention Description
ESWT will be applied to the affected elbow two days a week for 4 weeks, a total of 8 sessions, each session 2000 shock 10 Hz frequency, 2.5 bar intensity point and circumferential application.
Intervention Type
Other
Intervention Name(s)
Home Exercise
Intervention Description
Special static stretching and eccentric strengthening exercises for the forearm muscles will be taught and they will be asked to perform 2 sets (morning-lunch-evening) 10 repetitions per day, 5 days a week, for 4 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline Pain assessed by Visual Analog Scale.
Description
Pain will be evaluated with Visual Analog Scale. 0 means no pain, 10 means unbearable pain.
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Grip strength
Description
Grip strength will be evaluated with Hand Dynamometer
Time Frame
Baseline, 4 weeks
Title
Function assessed by Patient-rated Forearm Evaluation Questionnaire
Description
Function will be evaluated with Patient-rated Forearm Evaluation Questionnaire
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: being diagnosed with chronic LET by a physician visual analog scale (VAS) pain score ≥ 3 Exclusion Criteria: any accompanying pathology in the wrist and forearm, such as a fracture or dislocation of the elbow; treatment with corticosteroid injections in the past 6 months
Facility Information:
Facility Name
KTO Karatay University
City
Konya
State/Province
Karatay
Country
Turkey

12. IPD Sharing Statement

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Short and Long Term Effects of IASTM and ESWT Therapy in Individuals With Lateral Epicondylitis

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