JPRN-jRCTs062180003
Completed
Phase 2
Effectiveness of Low-Intensity Pulsed Ultrasound Effects on Patients with Lumbar Spondylolysis-Clinical Research on Efficacy and Safety- - LIPUS on Lumbar Spondylolysis
Sairyo Koichi0 sites23 target enrollmentOctober 31, 2018
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- umbar Spondylolysis
- Sponsor
- Sairyo Koichi
- Enrollment
- 23
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Study 1. Although this study has generally yielded good outcomes, it was indirectly influenced by Covid-19. Sufficient patients with such sports-related disorder were not collected due to self-restraint and cancellation of many sports events and competitions. Study 2. Contrary to our expectation, sufficient number of the patients were not collected.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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