Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)

Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study) - TAME: JMIS-1604 (INSTEP study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024385

Enrollment

Registered

2016-10-13

Start date

2016-10-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain from tendinopathy and enthesopathy refractory to non-surgical management

Interventions

Transcatheter arterial micro embolization: TAME

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Previous conservative therapies applied for at least 3 months and persistent moderate-to-severe hip pain (NRS>=5). 2.Lateral epicondylitis, medial epicondylitis, patella tendinitis, Achilles tendinitis, or plantar fasciitis is clinically diagnosed or suspected. 3.Patients with maintain major organ (bone marrow, heart, liver, lung, kidney) function. 4.Patients with possibility of going to hospital and follow up for 6 months. 5.Provided written informed consent to undergo the procedure.

Exclusion criteria

Exclusion criteria: 1.Surgical candidate 2.Patients with severe infection, rheumatoid arthritis, or mental disorder 3.Patients with uncontrollable diabetic mellitus 4.Pain due to spine pathology 5.Patients with osteonecrosis with magnetic resonance imaging (MRI) 6.Patients without possibility of going to hospital and follow up for 6 months. 7.Patient who was decided not to be appropriate for this trial by physician

Design outcomes

Primary

Measure	Time frame
1)Numerical Rating Scale (NRS) in 6 months after procedure 2)lateral epicondylitis or medial epiconylitis: Quick Disablities of the Arm, Shoulder and Hand (DASH) score in 6 months after the procedure, Patella tendinitis: Victorian Institute of Sport Assessment (VISA) score in 6 months after the procedure, Achilles tendinitis or plantar fasciitis: Foot & Ankle Disability Index (FADI) score in 6 months after the procedure 3)Quality of life(QOL) in 6 months after the procedure	—

Measure

Time frame

1)Numerical Rating Scale (NRS) in 6 months after procedure 2)lateral epicondylitis or medial epiconylitis: Quick Disablities of the Arm, Shoulder and Hand (DASH) score in 6 months after the procedure, Patella tendinitis: Victorian Institute of Sport Assessment (VISA) score in 6 months after the procedure, Achilles tendinitis or plantar fasciitis: Foot & Ankle Disability Index (FADI) score in 6 months after the procedure 3)Quality of life(QOL) in 6 months after the procedure

—

Countries

Japan

Contacts

Public ContactTaku Yasumoto

Miyakojima IGRT clinic Department of Interventional Radiology

yasumoto@solid.ocn.ne.jp06-6923-3501

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026