Effectiveness of LIPUS on Patients with Lumbar Spondylolysis

JRCT ID: jRCTs062180003

Registered date:31/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lumbar Spondylolysis
• Date of first enrollment: 29/01/2018
• Target sample size: 75
• Countries of recruitment: No,Japan
• Study type: Interventional
• Intervention(s): Low-Intensity Pulsed Ultrasound

Outcome(s)

• Primary Outcome: Bony fusion rate among the treated fracture sites

Secondary Outcome

Bony fusion rate among the patients
Treatment period required for bony union
Recurrent rate
Physical features affecting bony fusion
Incidence of diseases, etc (adverse events)

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: <= 50age old
• Gender: Both

Include criteria

1) Patients diagnosed with lumbar spondylolysis (stress fracture)
2) Under 50 years old
3) Regardless of gender
4) Patients requiring conservative treatment for bony union below
a) Progressive-stage spondylolysis based on CT scans and/or MRI
b) Delayed/Non union at more than 6 months follow-up after surgery.
5) Patients with written consent to participate in this study

Exclude criteria

Patients obtained with no agreement, patients who do not continue the treatment.
1) Patients who cannot wear the brace for the treatment
2) Patients who cannot continue the treatment due to any complications.
3) Patients who cannot complete the treatment through the defined period

Related Information

• Primary Sponsor: Sairyo Koichi
• Secondary ID(s): UMIN000029235