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治験 NCT07494591（対象：Ipsilateral Shoulder Pain、ビデオ支援胸腔鏡手術）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery 216 非侵襲
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07494591 は 介入研究 臨床試験 で、Ipsilateral Shoulder Pain、ビデオ支援胸腔鏡手術 に関するものです。現在は 募集準備中 で、2026年4月1日 に開始予定です。216 名の参加者 の募集が計画されています。この試験は Shanghai Pulmonary Hospital, Shanghai, China によって主導され、2026年12月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
Shoulder pain is a common problem after certain types of lung surgery called video-assisted thoracoscopic surgery (VATS). This study examines whether a treatment called transcutaneous electrical acupoint stimulation (TEAS) can help reduce this pain. TEAS is a non-invasive technique that uses mild electrical stimulation at specific points on the body.Patients who are having VATS lung surgery will be randomly assigned ...もっと見る
詳細説明
Ipsilateral shoulder pain (ISP) is a common and often debilitating complication following video-assisted thoracoscopic surgery (VATS) for lung surgery, significantly impacting patient recovery and quality of life. Current pain management strategies are not always fully effective in preventing or alleviating ISP. Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-pharmacological intervention that has shown...もっと見る
公式タイトル
Preoperative Transcutaneous Electrical Acupoint Stimulation for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery: A Multi-Center, Single-Blind, Randomized Controlled Trial
疾患名
Ipsilateral Shoulder Painビデオ支援胸腔鏡手術その他の研究識別子
- L25-604
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的TEAS Group Participants will receive preoperative transcutaneous electrical acupoint stimulation (TEAS) . TEAS will be administered for 30 minutes twice: (1) the evening before surgery and (2) before anesthesia induction on the day of surgery. | TEAS TEAS is a non-invasive transcutaneous electrical stimulation procedure. The TEAS device delivers a sparse-dense waveform. The current intensity is set within a range of 2-20 mA. The intervention administrator adjusts the current intensity within the pre-defined safety limits according to patient tolerance to maintain a mild soreness/"deqi" sensation. TEAS will be delivered twice for 30 minutes each: in the evening th...もっと見る |
シャム対照薬Sham TEAS Group The control group receives a sham stimulation procedure with sensory matching. Sham TEAS will be administered for 30 minutes twice: (1) the evening before surgery and (2) before anesthesia induction on the day of surgery. | Sham TEAS he sham procedure is a sensory-matched inactive stimulation. During the first 30 seconds, identical stimulation parameters to the active TEAS group are delivered using a sparse-dense waveform with instantaneous stimulation (5-10 mA) to produce a mild tingling sensation matched to the active arm. After 30 seconds, the device stops delivering effective electrical current while maintaining normal indicator lights and th...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of Ipsilateral Shoulder Pain (ISP) with Shoulder Movement at 24 Hours Postoperatively | Pain intensity will be assessed using the Verbal Rating Scale (VRS, 0-10, with 10 indicating worst pain). Participants will perform maximal shoulder circumduction (anterior, superior, posterior, inferior) in sitting/standing position with elbow extended, and the maximum VRS score will be recorded. ISP is defined as a VRS score ≥1. | 24 Hours Postoperatively |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Cumulative Opioid Consumption at 24 Hours Postoperatively | Total opioid use within 24 hours postoperatively will be recorded and converted to intravenous morphine equivalents. | 24 Hours Postoperatively |
Incidence of Postoperative Nausea and Vomiting (PONV) at 24 Hours Postoperatively | The number of participants experiencing nausea or vomiting within 24 hours postoperatively will be recorded. | 24 Hours Postoperatively |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Patients scheduled for unilateral thoracic surgery
- Age ≥ 18 years, regardless of gender
- ASA physical status classification I-III
- No severe cardiopulmonary insufficiency or other major comorbidities
- Pre-existing shoulder pain or functional impairment
- Severe mental illness or cognitive impairment
- Bilateral thoracic surgery
- Any other conditions deemed inappropriate by the investigators (with reasons to be documented)
Shanghai Pulmonary Hospital, Shanghai, China責任者
Shiyou Wei, 主任研究者, Attending Physician, Shanghai Pulmonary Hospital, Shanghai, China
試験中央連絡先
連絡先: Shiyou Wei, 15601680099, [email protected]
連絡先: Xin Lv, 13661869919, [email protected]
3 1カ国の場所
Shanghai Municipality
Shanghai Pulmonary Hospital, Shanghai, Shanghai Municipality, 200082, China
Shanghai East Hospital,Affiliated to Tongji University, Shanghai, Shanghai Municipality, 200120, China
Fudan university Shanghai cancer center, Shanghai, Shanghai Municipality, China