Lateral EpicondylitisNCT05683275
Short and Long Term Effects of IASTM and ESWT Therapy in Individuals With Lateral Epicondylitis
A study testing IASTM, ESWT and Home Exercise in people with Lateral Epicondylitis, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- IASTM, ESWT and Home Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Dec 2022to 7 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being diagnosed with chronic LET by a physician
- visual analog scale (VAS) pain score ≥ 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Long Term Effects of Instrument Assisted Soft Tissue Mobilization and Extracorporeal Shock Wave Therapy in Individuals With Lateral Epicondylitis
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.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- IASTM, ESWT, Home Exercise
- Keywords
- Lateral epicondylitis, pain, function, grip strength
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTMOther
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.
ESWTOther
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.
Home ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IASTM | Experimental | 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. Receives: Other: IASTM |
| ESWT | Experimental | 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. Receives: Other: ESWT |
| Home Exercise | Experimental | 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. Receives: Other: Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks
Secondary outcomes (2)
Grip strength
Grip strength will be evaluated with Hand Dynamometer
Measured: Baseline, 4 weeks
Function assessed by Patient-rated Forearm Evaluation Questionnaire
Function will be evaluated with Patient-rated Forearm Evaluation Questionnaire
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start28 Dec 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683275
- Sponsor's protocol ID
- KaratayUH6
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Effects of Instrument Assisted Soft Tissue Mobilization and Extracorporeal Shock Wave Therapy in Individuals With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05683275
- Acronym / sponsor ID
- KaratayUH6
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral epicondylitis, pain, function, grip strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IASTM | Experimental | Other: IASTMIn 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 | Experimental | Other: ESWTESWT 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. |
| Home Exercise | Experimental | Other: Home ExerciseStatic 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- being diagnosed with chronic LET by a physician
- visual analog scale (VAS) pain score ≥ 3
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IASTMIASTM 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. | Other | IASTM |
| ESWTESWT 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. | Other | ESWT |
| Home ExerciseSpecial 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. | Other | Home Exercise |
Primary outcome
Change from Baseline Pain assessed by Visual Analog Scale.
Time frame: Baseline, 4 weeks
Pain will be evaluated with Visual Analog Scale. 0 means no pain, 10 means unbearable pain.
2 secondary outcomes
Grip strength
Time frame: Baseline, 4 weeks
Function assessed by Patient-rated Forearm Evaluation Questionnaire
Time frame: Baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM, ESWT and Home Exercise in people with Lateral Epicondylitis, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pain assessed by Visual Analog Scale. (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.