| 基本情報/Basic information |
| 一般向け試験名/Public title |
高位脛骨骨切り術患者に対する術後早期の疼痛管理教育の効果：準ランダム化比較試験 |
Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial |
| 一般向け試験名略称/Acronym |
高位脛骨骨切り術患者に対する術後早期の疼痛管理教育の効果：準ランダム化比較試験 |
Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial |
| 科学的試験名/Scientific Title |
高位脛骨骨切り術患者に対する術後早期の疼痛管理教育の効果：準ランダム化比較試験 |
Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial |
| 科学的試験名略称/Scientific Title:Acronym |
高位脛骨骨切り術患者に対する術後早期の疼痛管理教育の効果：準ランダム化比較試験 |
Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial |
| 試験実施地域/Region |
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| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
術前と術後5週におけるNRSを使用した安静時と歩行時痛 |
Pain of rest and walking using the numerical rating scale at pre-operation and post-operation 5weeks |
| 副次アウトカム評価項目/Key secondary outcomes |
術前と術後5週における痛み破局化尺度による痛みの破局化、痛み自己効力感質問票による痛みの自己効力感、対処戦略質問票による痛みの対処戦略、10m歩行テスト、等尺性膝伸展筋力 |
Pain catastrophizing using the pain catastrophizing scale, pain self efficacy using pain self efficacy questionnaire, pain pain management strategies using coping strategy questionnaire, 10m walking test, and isometric muscle strength at pre-operation and post-operation 5weeks
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| 介入/Intervention |
| 群数/No. of arms |
3 |
| 介入の目的/Purpose of intervention |
予防・検診・検査/Prevention |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
対照群：リハビリテーションのみ（60分/日、6回/週） |
Control group: rehabilitation alone (60 min/day, 6 times/week) |
| 介入2/Interventions/Control_2 |
介入群1：リハビリテーションとグループスタイルの疼痛管理教育の併用（1時間/回を5回、5週間実施） |
Intervention group 1: combined rehabilitation and group-style pain management education (5 sessions of 1 hour/session for a total of 5 weeks) |
| 介入3/Interventions/Control_3 |
介入群2：リハビリテーションとグループ形式およびビデオを用いた疼痛管理教育の併用（1回約15分、3回（術前・術後3週・術後5週間）視聴 |
Intervention group 2: combined rehabilitation and group-style and video use pain management education (3 sessions of about 15 minutes per video, viewed preoperatively, 3 weeks postoperatively, and 5 weeks postoperatively) |
| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
（1）日本語を読んで話し、インフォームドコンセントを得た
（2）整形外科医の診断により変形性関節症と診断を受けた
（3）原発性の片側open-wedge HTO |
(1) read and speak Japanese and provided informed consent
(2) had a diagnosis of osteoarthritis as determined by their orthopedic surgeons, and(3) were scheduled for primary (not revision) unilateral open-wedge HTO |
| 除外基準/Key exclusion criteria |
（1）再置換関節形成術を予定
（2）試験参加に同意ができない、または拒否（3）自己申告による炎症性関節炎（すなわち、慢性関節リウマチ、全身性エリテマトーデス、または強直性脊椎炎）の診断。
（4）神経学的または心理学的疾患
（5）骨折、悪性腫瘍、または感染のためにHTOを受ける予定
（6）両側HTOの予定者
（7）片側関節形成術の予定者
（8）現在のHTO後6ヶ月以内に股関節または膝関節形成術を受ける予定の者
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(1) scheduled for revision arthroplasty surgery
(2) unable to or declined to provide consent for study participation
(3) had a self-reported diagnosis of inflammatory arthritis (i.e., rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis)
(4) had neurological or psychological disease
(5) scheduled to undergo HTO because of a fracture, malignancy, or infection
(6) scheduled for bilateral HTO
(7) scheduled for unilateral arthroplasty
(8) reported plans to undergo hip or knee arthroplasty within 6 months after the current HTO
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| 目標参加者数/Target sample size |
195 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-019-2913-5 |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
98 |
| 主な結果/Results |
傾向スコアマッチングの後、52組の患者が抽出された。介入群では、46名（88.5％）の患者がPNEを完了した。合計で、介入群の44人の患者と対照群の52人の患者を分析した。手術から5週間後、リハビリ自体もcatastrophizingを有意に減少させており、両群間の差は小さな効果量にとどまった（d＝0.44）。 |
After propensity score matching, 52 pairs of patients were extracted. In the intervention group, 46 patients completed the PNE. In total, 44 patients in the intervention group and 52 patients in the control group were analyzed. Five weeks following surgery, the rehabilitation itself had also significantly decreased catastrophizing, and the difference between the two groups had only a small effect size(d=0.44). |
| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
介入群と対照群の患者のベースライン人口統計と膝の症状の特徴を、傾向スコアマッチング分析の前後で比較した。試験登録前の年齢と合併症には両群間で有意差があったが、調整後には有意差はなかった。 |
The baseline demographics and knee symptom characteristics of the patients in the intervention and control groups before and after the propensity score-matching analysis. There were significant differences in age and complications before study enrollment between the two groups, but no significant differences were present after adjustment. |
| 参加者の流れ/Participant flow |
スクリーニングしてHTOを受けた266名の患者のうち、197名の患者が本研究への登録に適格であり、同意した。この197人の患者のうち、119人はPCSスコアが21点以上であり、本研究の対象となった。これらの患者は、傾向スコアマッチング分析により各群に疑似無作為に割り振られ、介入群に52人、対照群に52人が割り振られた。介入群では8名の患者が解析から除外された。 |
Of the 266 screened patients who underwent HTO, 197 patients were eligible and agreed to enroll in this study. Of these 197 patients, 119 had a PCS score of >21 and thus qualified for the current study. These patients were then pseudo-randomized into each group by a propensity score-matching analysis, resulting in 52 patients in the intervention group and 52 patients in the control group. Eight patients in the intervention group were excluded from the analysis. |
| 有害事象/Adverse events |
なし |
no
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| 評価項目/Outcome measures |
Pain catastrophizing scale, pain self-efficacy Questionnaire, 膝伸展筋力，10m歩行テスト |
Pain catastrophizing scale, pain self-efficacy Questionnaire, isometric knee extension strength, and 10-m walking test |
| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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UMIN-CTR 臨床試験登録情報の閲覧