Evidence map›Paper›PMID 27755279›Full record

Trial reportPain2016

Open-label placebo treatment in chronic low back pain: a randomized controlled trial.

Cláudia Carvalho, Joaquim Machado Caetano, Lidia Cunha, Paula Rebouta, Ted J Kaptchuk, Irving Kirsch

Erratum issued 6 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 6 registered trials, which are not on this map. Cited by 193 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
193citing papers in PubMed, 11 pooled it
–field-weighted citation impact
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.

NCT03547661 nacompletednot on this mapstarted 2018, after this paper: background citation

Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial

TypeinterventionalSponsorJens GaabRan2018 to 2021Enrolled150ConditionsPremenstrual SyndromeArmsP-Dragees rosa Lichtenstein
NCT03934138 naunknown statusnot on this mapstarted 2019, after this paper: background citation

Does the Subject's Understanding of Underlying Placebo Mechanisms Compensate for the Loss of Efficacy Associated With the Disclosure of the Use of a Placebo

TypeinterventionalSponsorLaboratoire TIMC-IMAGRan2019 to 2020Enrolled126ConditionsAcute PainArmsEducational movie on placebo mechanisms, Informative movie on hand washing
NCT05351333 naactive not recruitingnot on this mapstarted 2022, after this paper: background citation

Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

TypeinterventionalSponsorSpaulding Rehabilitation HospitalRan2022 to 2026Enrolled66ConditionsSpinal Cord Injuries, Polytrauma, BurnsArmsplacebo
NCT06350786 narecruitingnot on this mapstarted 2024, after this paper: background citation

Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Subacute or Chronic Pain Pain: a Randomized Controlled Trial

TypeinterventionalSponsorCosima LocherRan2024 to 2026Enrolled86ConditionsChronic Pain, Subacute PainArmsP-Dragees blue Lichtenstein, Placebo dragees, Control group (EM)
NCT06365892 narecruitingnot on this mapstarted 2024, after this paper: background citation

Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis

TypeinterventionalSponsorUniversity of California, San FranciscoRan2024 to 2026Enrolled64ConditionsAdolescent Idiopathic Scoliosis (AIS)Armsopen-label placebo, Treatment as usual
NCT07373210 narecruitingnot on this mapstarted 2026, after this paper: background citation

Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2026 to 2028Enrolled64ConditionsPeriacetabular Osteotomy, OpiatesArmsOpen-Label Placebo, Treatment as usual
3 · Its place in the literature

Who cites it

193 citing papers in PubMed, 11 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Manual Therapy Effect in Placebo-Controlled Trials: A Systematic Review and Meta-Analysis.International journal of environmental research and public health · 2022
    Pooled it
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  7. Placebo effects in low back pain: A systematic review and meta-analysis of the literature.European journal of pain (London, England) · 2021 · on this map
    Pooled it
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  15. Predictive biomarkers of placebo response in patients with cancer: an exploratory analysis of the ABCD randomized clinical trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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133 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Cláudia CarvalhoISPA-Instituto Universitário de Ciências Psicológicas, Sociais e da Vida, Department of Clinical and Health Psychology, Lisbon, Portugal.
Joaquim Machado CaetanoNova Medical School-Faculdade de Ciências Médicas, da Universidade Nova de Lisboa, Lisbon, Portugal.
Lidia CunhaUnidade de Terapia de Dor do Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.
Paula ReboutaUnidade de Terapia de Dor do Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.
Ted J KaptchukProgram in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Irving KirschProgram in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

Funding

Efficacy of Open-Label Placebo, Double-Blind Placebo, and Peppermint Oil in IBSR01AT008573 · NCCIH · BETH ISRAEL DEACONESS MEDICAL CENTER · PI KAPTCHUK, TED, LEMBO, ANTHONY J · 2015 to 2019
$4.3M
An fMRI study of expectancy on acupuncture treatment outcomes in knee OAR01AT005280 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI HIRSCHTICK, RANDY L, KAPTCHUK, TED · 2010 to 2014
$3.9M
Mentoring and Research in Placebo Studies, Asian Medicine, and CAMK24AT004095 · NCCIH · HARVARD MEDICAL SCHOOL · PI KAPTCHUK, TED · 2007 to 2016
$1.4M
Optimization of brain-based mechanisms supporting psychosocial aspects of acupuncture therapy - a hyperscanning fMRI studyR61AT009306 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI KAPTCHUK, TED, NAPADOW, VITALY · 2016 to 2017
$959k
NCCIH NIH HHS K24 AT004095NCCIH NIH HHS R01 AT005280NCCIH NIH HHS R01 AT008573NCCIH NIH HHS R61 AT009306
6 · The paper itself

Abstract

This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland-Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P < 0.001), with moderate to large effect sizes. Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (-0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (-1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.

Indexed as

AdultAnalgesicsAnalysis of VarianceChronic PainFemaleHumansLow Back PainMaleMiddle AgedMind-Body TherapiesPain MeasurementPlacebosRetrospective StudiesTreatment OutcomeYoung AdultAnalgesicsPlacebos

Identifiers

PMID27755279
PMCPMC5113234

What OpenQuestion holds

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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.