A Randomized-controlled Clinical Trial of Hypnosis Versus Open Label Placebo for Chronic Neuropathic Pain With an Investigation of Neuro-cognitive Dysfunctions as Maintaining Factors and Therapeutic Targets

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of the study is to a) assess the presence of a maladaptive stress response, a decreased pain modulation and any cognitive impairment in patients with chronic neuropathic pain in comparison to healthy controls. and b) evaluate the efficacy of a treatment of hypnosis and of an open label placebo on these neuro-cognitive factors and on clinical pain. This will be done through a) a prospective observational comparative study of patients (base line measures) with Healthy Controls (HC) and b) an Open label; randomised, hypnosis vs. open label placebo (OLP) vs. treatment as usual control design; with a second phase of exploratory cross-over.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• aged 18-90 years,

• interested in complementary medicine

• peripheral neuropathic pain lasting for more than 6 months,

• pain intensity of at least 3/10 VAS over the last two weeks

• matching patients for age and gender,

• no chronic pain condition no acute pain condition requiring daily intake of analgesics,

• no acute medical or psychiatric condition.

Locations
Other Locations
Switzerland
Lausanne University Hospital (CHUV)
RECRUITING
Lausanne
Contact Information
Primary
Chantal Berna Renella, MD PhD
chantal.berna-renella@chuv.ch
+41 795564744
Backup
Aurore Fernandez, MA
aurore.fernandez@chuv.ch
+4179 556 66 91
Time Frame
Start Date: 2018-11-01
Estimated Completion Date: 2024-10
Participants
Target number of participants: 72
Treatments
Experimental: Hypnosis
This represents 6 individual script-based sessions lasting 1h, distributed over 8 weeks, administered by a certified expert in therapeutic hypnosis. A set of standardized recordings are provided to use at home for self-hypnosis. Suggestions address deep relaxation, sensory substitution or transformation, pain intensity reduction, decreased pain unpleasantness and intensity, sense of control. A brief example of such suggestions: in this deeply relaxed state, you can imagine that your feet are covered in anesthetic… a deep layer of a powerful anesthetic medication, creating protective, soothing socks with which you can walk again….
Placebo_comparator: Open Label placebo
This consists in information provided with a placebo pill. Patients are asked to take the placebo pills as a self-healing ritual. The information relies on 4 points of explanation, i.e. (1) the placebo effect can be powerful, (2) the body automatically can respond to taking placebo pills like Pavlov dogs who salivated when they heard a bell, (3) a positive attitude can be helpful but is not necessary, and (4) taking the pills faithfully for the full duration of treatment is critical.
No_intervention: Usual care
Patients continue with their usual treatments
Related Therapeutic Areas
Sponsors
Leads: Chantal Berna

This content was sourced from clinicaltrials.gov