Feasibility clinical trial to evaluate initial safety and efficacy of treatment for pain relief using Focused ultrasound stimulator system ‘IMD20’ in patients with Lateral Epicondylitis by comparing pain scores using the NRS

Not Applicable

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0009381
• Lead Sponsor: IMGT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Adults of age = 19
2.A Person diagnosed with lateral epicondylitis.
3.Pain due to lateral epicondylitis rated at 5 points or above on the Numerical Rating Scale (NRS) at the screening.
4.Voluntarily decide to participate in this clinical trial and provide written informed consent form.
5.Willing to comply with the clinical trial protocol.

Exclusion Criteria

1.History of any of the following prior to the first intervention procedure (baseline):
?Use of any of the following within 2 days: acetaminophen, capsaicin products, narcotic analgesics, topical agents, or NSAIDs (including corticosteroids), except for celecoxib at a dosage of 100 mg bis in die (BID) or less.
?Extracorporeal shockwave therapy (ESWT) within 2 weeks.
?Corticosteroid injection within 4 weeks.
?Upper limb musculoskeletal surgery.
2.At the time of screening, a person has one or more of the following conditions that would make an investigational device application unsuitable
?Use of medical devices (such as pacemakers, brain stimulators, etc.) that may affect the performance of the investigational medical device.
?Inability to undergo intervention procedures due to wounds at the planned treatment site.
?Difficulty maintaining the intervention posture during the intervention procedure.
?Presence of foreign substances, either medical or non-medical, between the skin surface or treatment area in the pathway of the focused ultrasound.
3.Medical history at screening indicating the presence of one or more of the following:
?Allergies or hypersensitivity reactions due to ultrasound physical therapy.
?Pain at the planned treatment site due to causes other than lateral epicondylitis (e.g., neuropathic pain).
?Surgical symptoms at the planned treatment site (e.g., fractures, tears, osteoarthritis).
?Systemic infection or local infection around the planned treatment site.
4.Individuals with mental disorders or cognitive impairment making it difficult to follow the clinical trial guidelines or communicate with investigators.
5.Who are pregnant or breastfeeding
6.Among fertile female participants, those who do not agree to medically acceptable contraceptive methods* during the clinical trial period.
?Hormonal contraceptives, intrauterine devices (IUDs) or intrauterine systems (IUSs), tubal ligation, dual barrier methods (combination of male condoms, female condoms, cervical caps, diaphragms, and contraceptive sponges), single barrier methods combined with spermicides.
7.Currently participating in another clinical trial or having participated in another clinical trial within 30 days prior to the screening date.
8.Other reasons deemed inappropriate for participation in the clinical trial by the investigator due to ethical considerations or potential impact on clinical trial results.
? Specific reasons should be documented in the case report form.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ‘Pain’ score at each visit from the first intervention day.(score);Adverse event

Secondary Outcome Measures

Name	Time	Method
Sum of pain intensity difference, SPID;Total pain relief, TOPAR;Change in ‘PRTEE’ score at follow-up visit 1 and follow-up visit 2 from the first intervention day.(score);Change in ‘Quality of life’ score at follow-up visit 1 and follow-up visit 2 from the first intervention day.(score)