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Venlafaxine for Non-specific Low Back Pain

27 juli 2026 uppdaterad av: Fang Luo, Beijing Tiantan Hospital

Efficacy and Safety of Venlafaxine 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 Venlafaxine in chronic non-specific low back pain, which is of critical importance for optimising clinical practice and developing precise, individualised treatment regimens.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

228

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • China
      • Beijing, China, Kina, 100050
        • Beijing Tiantan Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Control Group
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain
Läkemedel: Control Group
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
Experimentell: Venlafaxine group
Venlafaxine is administered orally at a starting dose of 75 mg once daily. In patients with insufficient pain response who can tolerate the adverse effects, the dose may be carefully titrated up to 225 mg once daily. The maintenance period is 3 months.
Läkemedel: Venlafaxine group
Venlafaxine is administered orally at a starting dose of 75 mg once daily. In patients with insufficient pain response who can tolerate the adverse effects, the dose may be carefully titrated up to 225 mg once daily. The maintenance period is 3 months.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Average Low Back Pain Intensity at Month 3
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Average Low Back Pain Intensity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From randomization to 6 months after randomization
Adverse events will be recorded throughout the study
From randomization to 6 months after randomization

Samarbetspartners och utredare

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Sponsor

Beijing Tiantan Hospital

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

30 december 2028

Avslutad studie (Beräknad)

30 december 2028

Studieregistreringsdatum

Först inskickad

27 juli 2026

Först inskickad som uppfyllde QC-kriterierna

27 juli 2026

Första postat (Faktisk)

30 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KY2026-110-02-02

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

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Nej

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Nej

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