Evidence map›Paper›PMID 27831985›Full record

Trial reportSpine2016

Randomized, Double-blind, Placebo-controlled Phase III Trial of Duloxetine Monotherapy in Japanese Patients With Chronic Low Back Pain.

Shinichi Konno, Natsuko Oda, Toshimitsu Ochiai, Levent Alev

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Spine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07737158 (Efficacy and Safety of Venlafaxine in the Treatment of Non-specific Low Back Pain), which is not on this map. Cited by 40 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 8 pooled it
7.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07737158 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy and Safety of Venlafaxine in the Treatment of Non-specific Low Back Pain

TypeinterventionalSponsorBeijing Tiantan HospitalRan2026 to 2028Enrolled228ConditionsNon-specific Low Back Pain, Pain ManagementArmsControl Group, Venlafaxine group
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 8 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Antidepressants for low back pain and spine-related leg pain.The Cochrane database of systematic reviews · 2025
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  15. Inhalation ofPharmaceuticals (Basel, Switzerland) · 2023
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  16. Measures of sleep disturbance are not routinely captured in trials for chronic low back pain: a systematic scoping review of 282 trials.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Shinichi KonnoDepartment of Orthopedic Surgery, Fukushima Medical University, Fukushima, Japan.
Natsuko OdaShionogi and Co. Ltd, Osaka, Japan.
Toshimitsu OchiaiShionogi and Co. Ltd, Osaka, Japan.
Levent AlevMedicines Development Unit, Medical Science, Eli Lilly Japan K.K., Kobe, Japan.
Shionogi (Japan) · JPFukushima Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designA 14-week, randomized, double-blind, multicenter, placebo-controlled study of Japanese patients with chronic low back pain (CLBP) who were randomized to either duloxetine 60 mg once daily or placebo.

objectiveThis study aimed to assess the efficacy and safety of duloxetine monotherapy in Japanese patients with CLBP. SUMMARY OF BACKGROUND DATA: In Japan, duloxetine is approved for the treatment of depression, diabetic neuropathic pain, and pain associated with fibromyalgia; however, no clinical study of duloxetine has been conducted for CLBP.

methodsThe primary efficacy measure was the change in the Brief Pain Inventory (BPI) average pain score from baseline to Week 14. Secondary efficacy measures included BPI pain (worst pain, least pain, pain right now), Patient's Global Impression of Improvement, Clinical Global Impressions of Severity, and Roland-Morris Disability Questionnaire, among other measures, and safety and tolerability.

resultsIn total, 458 patients were randomized to receive either duloxetine (n = 232) or placebo (n = 226). The BPI average pain score improved significantly in the duloxetine group compared with that in the placebo group at Week 14 [-2.43 ± 0.11 vs. -1.96 ± 0.11, respectively; between-group difference (95% confidence interval), - 0.46 [-0.77 to-0.16]; P = 0.0026]. The duloxetine group showed significant improvement in many secondary measures compared with the placebo group, including BPI pain (least pain, pain right now) (between-group difference: -1.69 ± 0.10, P = 0.0009; -2.42 ± 0.12, P P = 0.0230, respectively), Patient's Global Impression of Improvement (2.46 ± 0.07, P = 0.0026), Clinical Global Impressions of Severity (-1.46 ± 0.06, P = 0.0019), and Roland-Morris Disability Questionnaire (-3.86 ± 0.22, P = 0.0439). Adverse events occurring at a significantly higher incidence in the duloxetine group were somnolence, constipation, nausea, dizziness, and dry mouth, most of which were mild or moderate in severity and were resolved or improved.

conclusionDuloxetine 60 mg was effective and well tolerated in Japanese CLBP patients. LEVEL OF EVIDENCE: 2.

Indexed as

AdultAgedAged, 80 and overChronic PainDouble-Blind MethodDuloxetine HydrochlorideFemaleFibromyalgiaHumansJapanLow Back PainMaleMiddle AgedPain MeasurementPlacebosTime FactorsDuloxetine HydrochloridePlacebos

Identifiers

PMID27831985
PMCPMC5113250
OpenAlexW2399329148

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.