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Clinical Trials/JPRN-jRCTs062180003
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.

Registry
who.int
Start Date
October 31, 2018
End Date
March 8, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sairyo Koichi

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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