5-Year Follow-Up of Open-Label Placebo Trial for Chronic Low Back Pain Relief

PainRelief.com: What should readers take away from your report?

Response:  Reducing the use of pain medication is a current goal in clinical practice.   Studies in various countries reveal that doctors often prescribe placebos to ease patients’ suffering. However, this approach is considered unethical and can undermine the necessary trust in the patient-provider relationship. Open label placebo is an honest strategy that may help increase pain-related self-efficacy and trigger the adoption of self-care health-related behaviors leading patients toward more engaged and active participation in their own healthcare.

PainRelief.com: What recommendations do you have for future research as a result of this study?

Response: The main limitation of our study is that the sample size was relatively small.  
We recommend additional studies with larger clinical samples. Also, because we offered OLP to control-group patients in the parent study, we didn’t have a control group in the follow up, which limits interpretation of the results, as we cannot assess whether the persistence of improvement was due to the original OLP intervention, spontaneous improvement, natural history or new interventions. Nevertheless, the improvement over baseline in our 5-year follow up (40% improvement in pain) is substantially larger than that found in untreated patients (17% improvement) and close to that reported for more invasive interventions (48% improvement) in analyses of long-term outcomes.  Finally, our study did not explore the mechanisms of the open label placebo.  This should be explored in future OLP studies with clinical populations.

PainRelief.com: Is there anything else you would like to add? Any disclosures?

Response: I am a professor and psychotherapist. The original RCT was performed at a public hospital in Lisbon and received some small funding from the Foundation for the Science of the Therapeutic Encounter.  The follow up study received no funding. There are no conflicts of interest to declare.

Citations:

Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial [published correction appears in Pain. 2017 Feb;158(2):365]. Pain. 2016;157(12):2766-2772. doi:10.1097/j.pain.0000000000000700

Carvalho C, Pais M, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo for chronic low back pain: a 5-year follow-up. Pain. 2020 Nov 30. doi: 10.1097/j.pain.0000000000002162. Epub ahead of print. PMID: 33259459.  

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