CompletedNot Applicable

Measuring the Effects of Complementary Therapies in Chronic Neuropathic Pain

Switzerland72 participantsStarted 2018-11-15

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients: Inclusion criteria: * 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 Exclusion criteria: * cognitive deficit (MMSE\<24/30), * severe hearing impairment, * acute psychiatric (e.g. suicidality, psychotic symptoms) or somatic (e.g. unstable cardiorespiratory condition) co-morbidity preventing full engagement in the 8-week study intervention, * prior negative experience with hypnosis, * allergy or intolerance to mannitol. Healthy controls: Inclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Interference due to pain (BPI interference)

Timeframe: at 8 weeks

pain severity (BPI pain scale)

Timeframe: at 8 weeks

fMRI of pain regulating circuitry (BOLD signal changes)

Timeframe: 8 weeks

Trial details

NCT IDNCT03783624

SponsorChantal Berna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-15

View on ClinicalTrials.gov More Neuropathic Pain trials