Toludesvenlafaxine for Non-specific Low Back Pain
24. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
132
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fang Luo
- Telefonnummer: +8659976661
- E-mail: 13611326978@163.com
Studiesteder
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Beijing, Kina, 100050
- Rekruttering
- Fang Luo
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Kontakt:
- Fang Luo
- Telefonnummer: 59976661
- E-mail: 13611326978@163.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Average Low Back Pain Intensity at Month 3
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Average Low Back Pain Intensity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. juli 2026
Primær færdiggørelse (Anslået)
1. september 2028
Studieafslutning (Anslået)
1. december 2028
Datoer for studieregistrering
Først indsendt
12. juli 2026
Først indsendt, der opfyldte QC-kriterier
12. juli 2026
Først opslået (Faktiske)
16. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KY2026-110-02-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
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