Toludesvenlafaxine for Non-specific Low Back Pain
24. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
132
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Fang Luo
- Telefonnummer: +8659976661
- E-Mail: 13611326978@163.com
Studienorte
-
-
-
Beijing, China, 100050
- Rekrutierung
- Fang Luo
-
Kontakt:
- Fang Luo
- Telefonnummer: 59976661
- E-Mail: 13611326978@163.com
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Control Group
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
|
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
|
|
Experimental: Toludesvenlafaxine Group
Participants in the toludesvenlafaxine group will receive oral toludesvenlafaxine in addition to background care.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Average Low Back Pain Intensity at Month 3
Zeitfenster: 3 months after randomization
|
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.
|
3 months after randomization
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Average Low Back Pain Intensity
Zeitfenster: Baseline, 1 month, and 6 months after randomization
|
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.
|
Baseline, 1 month, and 6 months after randomization
|
|
Change From Baseline in Functional Disability Assessed by the Roland-Morris Disability Questionnaire
Zeitfenster: Baseline, 1 month, 3 months, and 6 months after randomization
|
Functional disability related to low back pain will be assessed using the Roland-Morris Disability Questionnaire.
Higher scores indicate greater functional disability.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Global Perceived Recovery
Zeitfenster: 1 month, 3 months, and 6 months after randomization
|
Overall improvement will be assessed using a 6-point Likert scale ranging from "much worse" to "completely recovered."
|
1 month, 3 months, and 6 months after randomization
|
|
Change From Baseline in Health-related Quality of Life Assessed by EQ-5D-5L
Zeitfenster: Baseline, 1 month, 3 months, and 6 months after randomization
|
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.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Change From Baseline in Sleep Quality Assessed by the Insomnia Severity Index
Zeitfenster: Baseline, 1 month, 3 months, and 6 months after randomization
|
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.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Change From Baseline in Back Pain Beliefs Assessed by the Back Beliefs Questionnaire
Zeitfenster: Baseline, 1 month, 3 months, and 6 months after randomization
|
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.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Change From Baseline in Neuropathic Pain Features Assessed by the painDETECT Questionnaire
Zeitfenster: Baseline, 1 month, 3 months, and 6 months after randomization
|
Neuropathic pain features will be assessed using the painDETECT questionnaire.
A score of 19 or higher suggests the presence of a neuropathic pain component.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Use of Nonsteroidal Anti-inflammatory Drugs
Zeitfenster: Baseline, 1 month, 3 months, and 6 months after randomization
|
The amount and frequency of nonsteroidal anti-inflammatory drug use during the study period will be recorded.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Incidence of Adverse Events
Zeitfenster: From randomization to 6 months after randomization
|
Adverse events will be recorded throughout the study.
|
From randomization to 6 months after randomization
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Juli 2026
Primärer Abschluss (Geschätzt)
1. September 2028
Studienabschluss (Geschätzt)
1. Dezember 2028
Studienanmeldedaten
Zuerst eingereicht
12. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Juli 2026
Zuerst gepostet (Tatsächlich)
16. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- KY2026-110-02-01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .