Safety and efficacy of TAME for chronic musculoskeletal pain refractory to non-surgical management

JRCT ID: jRCTs061180011

Registered date:25/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Musculoskeletal chronic pain refractory to non-surgical management (Glenohumeral joint, elbow joint,
• Date of first enrollment: 06/11/2017
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Transcatheter arterial micro-embolization using IPM/CS

Outcome(s)

• Primary Outcome: Numerical Rating Scale (NRS) of pain
• Secondary Outcome: Feasibility of TAME

Key inclusion & exclusion criteria

• Age minimum: >= 13age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Previous conservative therapies applied for at least 3 months and persistent moderate-to-severe pain (NRS > 50mm)
2) Elbow, shoulder, hip, knee joint pain. For example, Patients with following diagnosis: adhesive capsulitis, musculoskeletal shoulder pain, tendinopathy and enthesopathy, synovitis and bursitis, mild osteoarthritis (KL<3), infrapatellar fat pad inflammation, and residual or recurrent pain after knee replacement surgery
3) Patients who maintain major organ (bone marrow, heart, liver, lung, kidney) function
4) Below 80 years old in age at the time of the agreement acquisition 20 years old or older
5) Patients who going to hospital follow-up after this treatment enforcement is possible
6) Provided written informed consent to undergo the procedure
7) In the case of a minor, acquisition of the informed consent from the substitute and the ascent from the principal
8) It is possible to re-enroll in the study after the end of the scheduled follow-up period of the previous study.

Exclude criteria

1) Adaptation of treating surgically
2) Neoplasm
3) Severe arteriosclerosis
4) Pregnant female, female with the possibility of the pregnancy or nursing female
5).6) Iodine Allergy
7) IPM/CS Allergy
8) Using sodium valproate
9) Patients with the past of hypersensitivity for carbapenem system, penicillin system or cephem antibiotics
10) Severe depression
11) Uncontrollable severe diabetes mellitus
12) Severe renal dysfunction (CCr<10ml/min), patient on hemodialysis
13) Patients who have difficulty in going to hospital follow-up after this treatment enforcement

14) Patients whose abnormal vessels are not recognized in an angiography

Related Information

• Primary Sponsor: Yata Shinsaku
• Secondary ID(s): UMIN000026094