JRCT ID: jRCT1032240285
Registered date:20/08/2024
The effect of extracorporeal shockwave therapy for medial tibial stress syndrome
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | medial tibial stress syndrome |
| Date of first enrollment | 26/02/2025 |
| Target sample size | 80 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Treatment times: no less than three (one every 1 to 2 weeks) Time of pulses per a treatment: about 1000 to 3000 pulses Intensity: The maximum intensity that the patient can tolerate Radial pressure wave, pressure 0.5 to 3.5 bar Focus shockwave 0.01 to 0.25 mJ per mm2 |
Outcome(s)
| Primary Outcome | The sites of pain (relateve to lower leg length) Pain severity Tenderness (manual pressure measurment and pressure algometer) Subject evaluation (visual analog scale, global rating scale, likert scale, pain during movement) |
|---|---|
| Secondary Outcome | Ultrasound image (the change of shear wave elastography; the adipose tissue, crural fascia, periosteum, flexor digit longus, tibial posterior, soleus) Participantion in practice and its duration |
Key inclusion & exclusion criteria
| Age minimum | >= 15age old |
|---|---|
| Age maximum | <= 40age old |
| Gender | Both |
| Include criteria | The patients who was diagnosed with medial tibial stress syndrome by a physician or medical institution. They need to undergo extracorporeal shock wave therapy (focused shock waves or radial pressure waves). The dianosis criteria: 1) exercise-induced pain along the posteromedial tibial border 2) tenderness along a length of at least 5 cm over the posteromedial tibial border 3) without neurological symptoms 4) without stress fracture and chronic exertional compartment syndrome |
| Exclude criteria | Individuals will be excluded if their physician's diagnosis differs or if it is determined that extracorporeal shock wave therapy is not applicable. |
Related Information
| Primary Sponsor | Kumai Tsukasa |
|---|---|
| Secondary Sponsor | Grant-in-aid for scientific research |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Takumi Okunuki |
| Address | 2-579-15 Mikajima, Tokorozawa City, Saitama Saitama Japan 3591192 |
| Telephone | +81-4-2947-6849 |
| t.okunuki@akane.waseda.jp | |
| Affiliation | Waseda University |
| Scientific contact | |
| Name | Tsukasa Kumai |
| Address | 2-579-15 Mikajima, Tokorozawa City, Saitama Saitama Japan 3591192 |
| Telephone | +81-4-2947-6849 |
| kumakumat@waseda.jp | |
| Affiliation | Waseda University |