試験ID UMIN000059062
最終情報更新日：2025年9月18日
急性腰痛症に対する腸腰筋へのハイボルテージ施術効果の持続時間の検討
基本情報
| 試験ID | UMIN000059062 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | 急性腰痛症に対する腸腰筋へのハイボルテージ施術効果の持続時間の検討 | Sustained Effects of High-Voltage Treatment on the Psoas Muscle in Patients with Acute Low Back Pain |
| 平易な研究名称 / Public Title（Acronym） | Sustained Effects of High-Voltage Treatment on the Psoas Muscle in Patients with Acute Low Back Pain | |
| 試験進捗状況/Recruitment status | 募集前 | Pending |
| 登録日時 | 2025年9月15日 | |
| 最終情報更新日 | 2025年9月18日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | Japan |
|---|---|---|
| 実施都道府県 | ||
| 目標症例数/Target sample size | 30 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 急性腰痛症 | Acute low back pain |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | 仰向けの状態でハイボルテージを左右の腸腰筋に5分（130Hz×3分、5Hz×2分）ずつを1回 | |
| 主要評価項目 / Primary outcomes | 施術前後および施術から3日後までのNumerical Rating Scale（NRS） | Numerical Rating Scale (NRS) before and after treatment, and up to 3 days after treatment |
| 副次評価項目 / Secondary outcomes | Pelvic tilt angle before and after treatment and three days later | |
適格性
| 年齢（下限）/ Age minimum | 18歳以上 | 18years-old |
|---|---|---|
| 年齢（上限）/ Age maximum | 80歳未満 | 80years-old |
| 性別 / Gender | 男女両方 | Male and Female |
| 選択基準 / Include criteria | Severe low back pain during activities of daily living Acute low back pain lasting less than 4 weeks Aged 18 to 80 years Moderate pain rated 4 or higher on the Numerical Rating Scale (NRS) | |
| 除外基準 / Exclude criteria | Waseda University undergraduate and graduate students Patients with conditions presumed to be specific low back pain Patients with clearly identifiable traumatic causes of injury Patients with dementia Patients with specific implanted electronic devices such as pacemakers Patients with acute (painful) conditions of unknown cause Patients with cardiac impairment Patients with high bleeding risk Patients with malignant tumors Patients with febrile illnesses Patients with infectious diseases Pregnant women or women who have recently given birth Patients at risk of vascular disorders such as thrombosis, venous thrombosis, or varicose veins Other patients deemed unsuitable by the physician Ischemic tissue Areas with moderate or severe edema Areas with sensory impairment Skin damage or inflamed areas Skin surfaces with venous distension (where veins are prominent) Areas with implanted metal or plastic objects (e.g., artificial joints, buried pins) Above the carotid sinus |
責任研究者
| 責任研究者 / Name of lead principal investigator | Koichiro Oka | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | Waseda University Faculty of Sport Sciences | |
| 住所 / Address | 2-579-15, Mikajima, Tokorozawa, Saitama Japan | |
| 電話 / Telephone | 042-947-7189 | |
| 実施責任組織 / Affiliation | 早稲田大学 | Waseda University Faculty of Sport Sciences |
| 研究費提供組織 / Funding Source | Self-funding | |
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | 2-579-15, Mikajima, Tokorozawa, Saitama Japan 359-1164 | |
|---|---|---|
| 電話 / Telephone | 090-9137-4279 | |
| ホームページURL | ||
| hadanodesu@akane.waseda.jp | ||
| 担当者 / Name of contact person | Ryujo Hadano |