Toludesvenlafaxine for Non-specific Low Back Pain
2026年7月24日 更新者：Fang Luo、Beijing Tiantan Hospital
Efficacy and Safety of Toludesvenlafaxine in the Treatment of Non-specific Low Back Pain
Chronic non-specific low back pain is the leading cause of productivity loss and disability worldwide, constituting a major public health challenge.
This study aims to systematically evaluate and compare the role of the antidepressant drug toludesvenlafaxine in chronic non-specific low back pain, which is of critical importance for optimising clinical practice and developing precise, individualised treatment regimens.
調査の概要
研究の種類
介入
入学 (推定)
132
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Fang Luo
- 電話番号：+8659976661
- メール：13611326978@163.com
研究場所
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Beijing、中国、100050
- 募集
- Fang Luo
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コンタクト：
- Fang Luo
- 電話番号：59976661
- メール：13611326978@163.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adults aged 18 to 75 years.
- Diagnosis of chronic nonspecific low back pain, defined as pain located below the costal margin and above the inferior gluteal folds, lasting for more than 3 months, without a specific pathological cause.
- Moderate to severe pain, defined as a Numerical Rating Scale score of 3 or higher.
- Able to understand the study procedures and sign written informed consent.
Exclusion Criteria:
- Low back pain caused by a known specific pathological condition, including but not limited to fracture, malignancy, infection, inflammatory disease, or other identifiable structural or systemic causes.
- Major comorbidities that may interfere with study outcomes or represent contraindications to the study medication.
- Current or previous diagnosis of depression, regardless of whether treatment was received.
- Current or previous use of antidepressant medication.
- Current use of opioid analgesics.
- Pregnancy, breastfeeding, or planned pregnancy during the study period.
- Known allergy, hypersensitivity, or contraindication to toludesvenlafaxine.
- History of psychosis or other major psychiatric disorders.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Control Group
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
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Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
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実験的：Toludesvenlafaxine Group
Participants in the toludesvenlafaxine group will receive oral toludesvenlafaxine in addition to background care.
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Participants in the toludesvenlafaxine group will receive oral toludesvenlafaxine in addition to background care.
Toludesvenlafaxine will be administered at 80 mg once daily.
For participants with insufficient pain relief and acceptable tolerability, the dose may be cautiously increased to 160 mg once daily.
The maintenance treatment period will be 3 months.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Average Low Back Pain Intensity at Month 3
時間枠：3 months after randomization
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Average low back pain intensity during the previous week will be assessed using an 11-point Numerical Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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3 months after randomization
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Average Low Back Pain Intensity
時間枠：Baseline, 1 month, and 6 months after randomization
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Average low back pain intensity during the previous week will be assessed using an 11-point Numerical Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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Baseline, 1 month, and 6 months after randomization
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Change From Baseline in Functional Disability Assessed by the Roland-Morris Disability Questionnaire
時間枠：Baseline, 1 month, 3 months, and 6 months after randomization
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Functional disability related to low back pain will be assessed using the Roland-Morris Disability Questionnaire.
Higher scores indicate greater functional disability.
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Baseline, 1 month, 3 months, and 6 months after randomization
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Global Perceived Recovery
時間枠：1 month, 3 months, and 6 months after randomization
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Overall improvement will be assessed using a 6-point Likert scale ranging from "much worse" to "completely recovered."
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1 month, 3 months, and 6 months after randomization
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Change From Baseline in Health-related Quality of Life Assessed by EQ-5D-5L
時間枠：Baseline, 1 month, 3 months, and 6 months after randomization
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Health-related quality of life will be assessed using the EQ-5D-5L.
The EQ-5D-5L includes five health dimensions, and each dimension has five severity levels.
Higher health utility scores indicate better health status.
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Baseline, 1 month, 3 months, and 6 months after randomization
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Change From Baseline in Sleep Quality Assessed by the Insomnia Severity Index
時間枠：Baseline, 1 month, 3 months, and 6 months after randomization
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Sleep quality and insomnia symptoms will be assessed using the patient-reported version of the Insomnia Severity Index.
The scale contains 7 items evaluating sleep onset difficulty, sleep maintenance difficulty, early morning awakening, satisfaction with sleep, interference with daytime functioning, noticeability of sleep problems, and distress caused by sleep difficulties.
Each item is scored from 0 to 4, and the total score ranges from 0 to 28.
Scores are interpreted as follows: 0-7, no clinically significant insomnia; 8-14, subthreshold insomnia; 15-21, moderate insomnia; and 22-28, severe insomnia.
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Baseline, 1 month, 3 months, and 6 months after randomization
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Change From Baseline in Back Pain Beliefs Assessed by the Back Beliefs Questionnaire
時間枠：Baseline, 1 month, 3 months, and 6 months after randomization
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Beliefs about back pain will be assessed using the Back Beliefs Questionnaire.
Scores range from 9 to 45, with lower scores indicating more pessimistic beliefs about the consequences of back pain.
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Baseline, 1 month, 3 months, and 6 months after randomization
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Change From Baseline in Neuropathic Pain Features Assessed by the painDETECT Questionnaire
時間枠：Baseline, 1 month, 3 months, and 6 months after randomization
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Neuropathic pain features will be assessed using the painDETECT questionnaire.
A score of 19 or higher suggests the presence of a neuropathic pain component.
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Baseline, 1 month, 3 months, and 6 months after randomization
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Use of Nonsteroidal Anti-inflammatory Drugs
時間枠：Baseline, 1 month, 3 months, and 6 months after randomization
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The amount and frequency of nonsteroidal anti-inflammatory drug use during the study period will be recorded.
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Baseline, 1 month, 3 months, and 6 months after randomization
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Incidence of Adverse Events
時間枠：From randomization to 6 months after randomization
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Adverse events will be recorded throughout the study.
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From randomization to 6 months after randomization
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
- Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
- Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6.
- Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, Patrick K. Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. J Pain. 2010 Dec;11(12):1282-90. doi: 10.1016/j.jpain.2010.03.002. Epub 2010 May 15.
- Leao Nunes Filho MJ, Barreto ESR, Antunes Junior CR, Alencar VB, Falcao Lins-Kusterer LE, Azi LMTA, Kraychete DC. Efficacy of antidepressants in the treatment of chronic nonspecific low back pain: a systematic review and meta-analysis. Pain Manag. 2024;14(8):437-451. doi: 10.1080/17581869.2024.2408215. Epub 2024 Oct 8.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月15日
一次修了 (推定)
2028年9月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年7月12日
QC基準を満たした最初の提出物
2026年7月12日
最初の投稿 (実際)
2026年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月27日
QC基準を満たした最後の更新が送信されました
2026年7月24日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- KY2026-110-02-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available.
Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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