Evaluating the effects of open-label placebos on chronic pain
Optimizing Open Placebos for Chronic Pain Patients
NA · Rhode Island Hospital · NCT06931158
This study tests how different explanations given with open-label placebos can help people with chronic low back pain feel better and possibly reduce their use of prescription opioids.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Rhode Island Hospital (other) |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06931158 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how different rationales provided with open-label placebos affect pain levels in patients with chronic low back pain. Participants will be assigned to various groups receiving either a standard rationale, mindfulness rationale, or no rationale while taking an open-label placebo, and their outcomes will be compared to those receiving no treatment. The study also aims to assess the impact of these rationales on prescription opioid use. By understanding the influence of rationales, the trial seeks to enhance the effectiveness of placebo treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who experience chronic low back pain lasting at least three months.
Not a fit: Patients with chronic pain due to cancer or those currently receiving worker's compensation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and cost-effective approach to managing chronic pain, potentially reducing reliance on prescription opioids.
How similar studies have performed: Other studies have shown promising results with open-label placebos, suggesting that this approach could be effective, although the specific use of rationales is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria are: * chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over) * at least 18 years old * English speaking * have a smartphone or computer with video access * the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate) Exclusion Criteria * Have chronic pain because of a cancer diagnosis * Over 89 years of age * Suspect an allergy to any placebo ingredient * Currently receiving worker's compensation.
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Study coordinator: Study Coordination
- Email: HOPE-trial@lifespan.org
- Phone: 401-606-4766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Low-back Pain, Chronic Pain, open-label placebo, rationales, placebo effect