Sham device v inert pill: randomised controlled trial of two placebo treatments.
Ted J Kaptchuk, William B Stason, Roger B Davis...
https://pubmed.ncbi.nlm.nih.gov/16452103/Actively Recruiting
Led by Northwestern University · Updated on 2026-06-25
210
Participants Needed
4
Research Sites
13 weeks
Total Duration
Researchers are studying patients with lumbosacral radiculopathy, a condition causing leg and back pain due to nerve irritation in the lower spine. This trial compares different ways of presenting epidural steroid injections ESI to patients, evaluating whether framing the treatment positively versus neutrally affects pain outcomes. The study also compares these approaches to standard medication and exercise, aiming to understand how patient expectations influence the placebo effect in pain treatments. Participants are randomly assigned to one of three groups one receiving a positive framing of ESI with detailed supportive information, another receiving a neutral framing of ESI with less optimistic information, and a third group receiving medications for neuropathic pain along with exercise instructions, presented in a neutral way. The framing involves reviewing slides about the treatment, with study staff available to answer questions. Subgroups are based on whether patients have unilateral or bilateral pain, affecting the type of ESI they may receive. Participants will be assessed for leg and back pain levels shortly after treatment and at 4 and 12 weeks. Researchers will measure pain reduction, disability, medication use, and patient satisfaction using various scales and questionnaires. The study includes baseline evaluations, treatment visits, and follow-ups to monitor outcomes and potential side effects. Total participation time covers at least 12 weeks, allowing detailed observation of treatment effects over time.
CONDITIONS
Procedural Framing and Epidural Steroid Injection Outcomes
S
Steven P Cohen, MD
J
Jordan Wood, BS
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Northwestern University
Lead Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | ESI with Positive Expectation Framing | ESI with Neutral Expectation Framing | Pharmacotherapy (Gabapentin, Nortriptyline, Duloxetine) with Neutral Framing |
|---|---|---|---|
| What is it? | Epidural steroid injection for lumbosacral radiculopathy, preceded by a behavioral intervention where the procedure is described in a positive light using a 5-slide summary and investigator guidance. | Epidural steroid injection for lumbosacral radiculopathy, preceded by a brief neutral summary (1 slide) of the procedure. | Pharmacotherapy for neuropathic pain using gabapentin, nortriptyline, or duloxetine, preceded by a neutral summary of medications. |
| Role in the trial | Investigational arm assessing impact of positive framing on ESI effectiveness. | Comparator arm evaluating neutral framing for ESI. | Comparator arm assessing neutral framing for pharmacotherapy in neuropathic pain. |
| Primary use | Evaluates whether positive behavioral framing increases perceived benefit and pain reduction from ESI in lumbosacral radiculopathy. | Serves as control to measure neutral framing effects on ESI outcomes. | Used to compare ESI outcomes to those with neuropathic pain pharmacotherapy under neutral framing. |
| How it is given or performed | Participants view a five-slide summary emphasizing positive outcomes of ESI with investigator support before their procedure. | Participants view a single-slide neutral summary about ESI before undergoing the injection. | Participants view a single-slide neutral summary about neuropathic pain medications before starting pharmacotherapy. |
| Evidence status | Ongoing study; published evidence highlights influence of expectation and placebo effects in procedural and pharmacological interventions. | Neutral framing is being actively investigated; studies have shown that neutral expectation does not maximize placebo benefits. | Neutral framing of pharmacotherapy is being studied; meta-analyses show placebo effects contribute significantly to pain reduction in pharmacological trials. |
| Important limitations | Study results may be influenced by patient personality traits, variable placebo responsiveness, and framing effectiveness across individuals. | Neutral framing may not capture full placebo enhancement possible with positive expectation; placebo benefits seen in device procedures can differ from those in medication studies. | Pain relief from pharmacotherapy may be affected by previous failed medication trials and personality-related placebo responsiveness. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks
Participants will receive epidural steroid injections with either positive or neutral framing, or medication with exercise instructions, depending on their assigned group. They will review educational materials about their treatment during this stage.
Duration - Up to 12 weeks
Participants will have assessments to measure leg and back pain, disability, medication use, and satisfaction at various points up to 12 weeks after treatment.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/39733973/Northwestern University
Lead Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborating Sponsor