Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions: multi-institutional prospective randomized controlled trial

Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions: multi-institutional prospective randomized controlled trial - Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002005

Enrollment

Registered

2009-06-01

Start date

2009-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

scaphoid delayed unions and nonunions

Interventions

The scaphoid delayed unions or nonunions were treated with internal screw fixation with bone grafting The scaphoid delayed unions or nonunions were treated with internal screw fixation with bone graft

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The primary scaphoid delayed union or nonunion surgery with internal screw fixation with bone grafting 2) The patients aged between 16 and 64 years are recruied

Exclusion criteria

Exclusion criteria: 1) Scaphoid partially united fractures 2) The scaphoid delayed unions or nonunions treating with vascularized bone grafting 3) The patient presented arthritis of the wrist 4) The proximal pole nonunions with avascular necrosis, which was proved with MRI 5) The patient receiving LIPUS treatment before 6) The patient receiving electrical stimulation 7) The patient who is unable to apply LIPUS treatment 8) The patient had recent severe systemic past history such as heart, liver or kidney disease 9) The patient had treated cancer therapy within recent five years 10) The patient is pregnant or possible pregnant 11) The patient entering for other medical trials 12) The patient who is unable to comply with this study protocol 13) The patient who is unable to comply with the consent form of this study 14) The patient who was recognized unsuitable for this study by primary physician

Design outcomes

Primary

Measure	Time frame
The end-point of the study is a healed period of the scaphoid delayed unions or nonunions, as judged on CT examination	—

Secondary

Measure	Time frame
1) Functional outcomes are assessed with the Disability of the Arm, Shoulder, and Hand Japanese version (DASH-JSSH) 2) The study is a healed period of the scaphoid delayed unions or nonunions, as judged on radiographic examination 3) Functional outcomes are assessed with the Visual Analog Scale (VAS) for pain 4) Functional outcomes are assessed with the grip strength improvement at pre-operation, and 16 weeks after operation period. 5) Functional outcomes are assessed with the Range of motion of the wrist improvement at pre-operation, and 16 weeks after operation period.	—

Measure

Time frame

1) Functional outcomes are assessed with the Disability of the Arm, Shoulder, and Hand Japanese version (DASH-JSSH) 2) The study is a healed period of the scaphoid delayed unions or nonunions, as judged on radiographic examination 3) Functional outcomes are assessed with the Visual Analog Scale (VAS) for pain 4) Functional outcomes are assessed with the grip strength improvement at pre-operation, and 16 weeks after operation period. 5) Functional outcomes are assessed with the Range of motion of the wrist improvement at pre-operation, and 16 weeks after operation period.

—

Countries

Japan

Contacts

Public ContactKoichi Hashimoto

University of Tsukuba Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL)

koichi.hashimoto@md.tsukuba.ac.jp029-853-3326

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026