Effects of open-label placebo on pain, functional disability, and spine mobility in patients with chronic back pain: a randomized controlled trial

Abstract

Chronic back pain (CBP) is a major global health problem, while its treatment is hampered by a lack of efficacy and restricted safety profile of common frontline therapies. The present trial aims to determine whether a 3-week open-label placebo treatment reduces pain intensity and subjective and objective functional disability in patients with CBP. This randomized controlled trial, following a pretest–posttest design, enrolled 127 patients with CBP (pain duration >12 weeks) from the Back Pain Center, Neurology, University Hospital Essen, Germany. Patients randomized to the open-label placebo group received a 3-week open-label placebo treatment. Patients in the treatment as usual (TAU) group received no intervention. Both groups continued TAU. Primary outcome was the change in pain intensity. Secondary outcomes included patient-reported functional disability and objective measures of spine mobility and depression, anxiety, and stress. One hundred twenty two patients with CBP were randomized to the open-label placebo group (N = 63) or TAU group (N = 59). Open-label placebo application led to a larger reduction of pain intensity (−0.62 ± 0.23 vs 0.11 ± 0.17, all M ± SE, P = 0.001, d = −0.44) as well as patient-reported functional disability (3.21 ± 1.59 vs 0.65 ± 1.15, P = 0.020, d = −0.45) and depression scores (−1.07 ± 0.55 vs 0.37 ± 0.39, P = 0.010, d = −0.50) compared with TAU only. Open-label placebo treatment did not affect objective mobility parameters, anxiety and stress. Our study demonstrates that a 3-week open-label placebo treatment is safe, well tolerated and reduces pain, disability, and depressive symptoms in CBP. Trial registration: German Clinical Trials Register, DRKS00012712.

Open-label placebos for menopausal hot flushes: a randomized controlled trial

“…After discontinuing or tapering placebo pills, most patients remained improved. Sustained OLP effects were also found in the first two studies including exploratory follow-up phases with cancer patients with chronic fatigue after undergoing chemotherapy 8 and chronic back pain patients 5 .…”

“…Prescribing placebos in an honest manner would eliminate the ethically problematic use of deceptive placebos or active medications that have no efficacy for the treated condition (“impure placebos”) in the clinical setting 2 . The first randomized controlled trial (RCT) on open-label placebos (OLP) was conducted in 2010 among patients with irritable bowel syndrome 3 , followed by further RCTs on chronic back pain 4 , 5 , depression 6 , allergic rhitinis 7 , and cancer-related fatigue 8 . A meta-analysis from 2017 found an overall positive effect of 0.9, indicating a large effect of OLP compared to no-treatment 9 .…”

Conditioning open-label placebo: a pilot pharmacobehavioral approach for opioid dose reduction and pain control

“… 2 , 7 Open-label placebo involves the presentation of the placebo to the patient and explaining the purpose and possible benefits of this option. Moreover, OLP has already been successfully demonstrated in a pilot randomized controlled trial (RCT) in patients suffering from pain 6 , 9 , 10 , 13 and nonpain conditions. 1 , 11 , 14 …”

Paracetamol for low back pain: the state of the research field

“…There are even open-label placebo trials in the field of back pain, in which patients are told that they would receive placebo, which show positive effects on pain and disability [47,48]. On the other hand, we know that placebo-effects in trials may be exceeding 30% of the total observed effect, and that these placebo effects may not be reflected in clinical practice [49].…”