Measuring the Effects of Complementary Therapies in Chronic Neuropathic Pain

NCT03783624 | Unknown DMC

• 1 other identifier: CER-VD 2017- 00924
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain

Keywords

hypnosis; open label placebo; neurocognitive measures; stress; induced pain; HRV

Outcome Measures

Primary Outcomes (3)

• Interference due to pain (BPI interference)

  Brief Pain Inventory, mean interference with function score (score 0-10), with higher scores meaning higher interference.

  at 8 weeks

• pain severity (BPI pain scale)

  Brief Pain Inventory, mean pain intensity score over last 2 weeks (score 0-10) with higher scores meaning higher pain

  at 8 weeks

• fMRI of pain regulating circuitry (BOLD signal changes)

  BOLD signal will be measured during pain perception

  8 weeks

Secondary Outcomes (14)

• Stress response measured through Cortisol awakening response

  at 8 weeks

• Stress response measured through Heart rate variability (HRV)

  at 8 weeks

• Pain modulation: modulation of induced pain through mental imagery and expectations. The outcome measure is on pain Visual Analogue Scale (VAS) for unpleasantness

  at 8 weeks

• Pain modulation: modulation of induced pain through mental imagery and expectations. The outcome measure is on pain Visual Analogue Scale (VAS) for intensity

  at 8 weeks

• Trail making test (outcomes in time, seconds)

  at 8 weeks

Other Outcomes (4)

• second phase cross-over choice

  8 weeks

• Long term outcomes on the Brief Pain Inventory (BPI)

  24 weeks

• expectations regarding treatment effects

  8 weeks, 24 weeks

Study Arms (3)

Hypnosis

EXPERIMENTAL

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…".

Behavioral: Hypnosis

Open Label placebo

PLACEBO COMPARATOR

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.

Behavioral: Open label placebo

Usual care

NO INTERVENTION

Patients continue with their usual treatments

Interventions

Hypnosis BEHAVIORAL

A 6 session course of individual hypnosis therapy will be offered.

Hypnosis

Open label placebo BEHAVIORAL

Ritual intake of 2 placebo capsules twice a day

Open Label placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Chantal Berna: lead

Study Sites (1)

Lausanne University Hospital (CHUV)

Lausanne, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Chantal Berna Renella, MD PhD

CONTACT

+41 795564744; chantal.berna-renella@chuv.ch

Aurore Fernandez, MA

CONTACT

+4179 556 66 91; aurore.fernandez@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: due to the nature of the treatment (Open label placebo, hypnosis)patients and care providers will be in an open label setting, however the investigators and outcomes assessors will be blinded to the conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: December 21, 2018
• Study Start: November 1, 2018
• Primary Completion: March 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

CH (1)