Toludesvenlafaxine for Non-specific Low Back Pain
2026년 7월 24일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
132
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Fang Luo
- 전화번호: +8659976661
- 이메일: 13611326978@163.com
연구 장소
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Beijing, 중국, 100050
- 모병
- Fang Luo
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연락하다:
- Fang Luo
- 전화번호: 59976661
- 이메일: 13611326978@163.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Average Low Back Pain Intensity at Month 3
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Average Low Back Pain Intensity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 15일
기본 완료 (추정된)
2028년 9월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 7월 12일
QC 기준을 충족하는 최초 제출
2026년 7월 12일
처음 게시됨 (실제)
2026년 7월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 24일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KY2026-110-02-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .