Neuropathic PainPSYCNEPNCT02256371
Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain
A study testing Hypnosis sessions and Relaxation group in people with Neuropathic Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A randomized double-blind controlled two centers study. The primary objective of this study will be to show a superiority of hypnosis over relaxation on pain intensity in patients with neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Hypnosis sessions and Relaxation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- peripheral or central neuropathic pain, probable or definite
- Diagnostic questionnaire score DN4 ≥ 4/10
- Chronic Pain with an average of pain intensity greater than or equal to 4/10 (digital scale)
- Presence of daily or almost daily pain (i.e. at least 4 days per week)
- Patient with pre-existing pain for > 6 months
- Patient > 18 and < 60 years old
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- Patient with a stable analgesic treatment since 15 days before inclusion
- Patient able to participate to the trial during 33 weeks
- Patient having a health insurance
- Written informed consent signed by the patient.
Who cannot join
- Prior treatment with hypnosis
- Currently under active psychotherapy (Cognitive-Behavior Therapy, psychoanalysis)
- Work accident or litigation
- Drugs abuse or Psychoactive Substance Abuse (DSM-IV)
- Neuropathic pain associated with progressive disease (MS, HIV, cancer ...)
- Major depression with ongoing disability or psychosis (DSM IV)
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- Intermittent pain
- Patient with pre-existing pain for < 6 months
- Other more severe pain than the pain justifying inclusion
- Subject unable to understand the trial information provided in the informed consent document
- Subject under curators or guardianship
- Severe Handicap or amputation
- Participation to another study in the same period
- Deafness
- Cognitive disorders (dementia, Mild Cognitive Impairment, inability to understand the questionnaires)
- For patients of the control arm: Treatment by hypnosis and / or relaxation, transcranial magnetic stimulation, or invasive treatments (surgery)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, 92100
About this study
Official title: Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study
A randomized double-blind controlled two centers study. The primary objective of this study will be to show a superiority of hypnosis over relaxation on pain intensity in patients with neuropathic pain.
Read the detailed description
The secondary objectives of this study are:
- to show a superiority of hypnosis and relaxation over control group on neuropathic pain.
- to show a lasting effect of treatment on neuropathic pain one week after the end of treatment.
- to evaluate the clinical predictors of response to hypnosis (nature of neuropathic symptoms, severity of anxiety and depressive symptoms, pain catastrophizing, coping strategies, emotional regulation, response to the first session, positive or negative emotional reaction at the end of hypnosis sessions).
- to evaluate the effect of hypnosis at long-term (1, 3 and 6 months after the end of treatment).
- to evaluate the effect of hypnosis on emotional processes.
- to compare hypnosis to relaxation on short-term effects on pain,
- to evaluate the quality of life and the impact of pain on daily life: sleep, mood, anxiety symptoms, analgesics consumption , neuropathic symptoms, affective component of pain and pain catastrophizing. 35 patients will be enrolled in each arm, to obtain 105 in total (3 arms). Total duration for each patient: 8 months.
- Conditions
- Neuropathic Pain
- Being tested
- Hypnosis sessions, Relaxation group
- Keywords
- Neuropathic pain, Hypnosis, Relaxation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis sessionsBehavioural
1 session per week during 8 weeks
Relaxation groupBehavioural
1 relaxation session per week during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hypnotic analgesia | Experimental | Hypnosis sessions:
Hypnosis will consist of 45 minutes hypnosis session with a trained hypnotherapist Receives: Behavioral: Hypnosis sessions |
| Relaxation | Experimental | Relaxation group:
Relaxation will be conducted in 45 minutes sessions with a trained psychotherapist. Receives: Behavioral: Relaxation group |
| Routine care | No intervention | The patients will receive their usual pain treatments throughout the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly mean pain intensity in patients diaries
The pain intensity score will be recorded daily by each patient on a self-assessment diary using a scale of 0 to 10. The record will begin from the first session of hypnosis or relaxation to the last session (S1 to S9).
Measured: 9 week
Secondary outcomes (13)
Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment
Pain intensity measured at the end of each hypnosis or relaxation session and 3 and 6 months after the end of the treatment
Measured: 8 months
Evaluation of the feeling of comfort and relaxation
At the end of each hypnosis or relaxation session, with a scale from 0 to 10.
Measured: 9 weeks
Affective components of pain
At the end of each visit and 3 and 6 months after the end of the treatment
Measured: 8 months
Emotional processes and Alexithymia
Measured: 8 months
Neuropathic symptoms (NPSI)
Measured: 8 months
Interference with pain (Brief Pain Inventory)
Measured: 8 months
Quality of life assessment
Measured: 8 months
Depression and anxiety
Measured: 8 months
Emotional distress caused by pain
Measured: 8 months
Pain catastrophizing
Measured: 9 months
Pain relief
Measured: 8 months
Delay of onset of analgesic effects
Measured: 8 weeks
Percentage of responders
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startJan 2015
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine ATTAL, MD, PhD, Principal investigator, Groupe Hospitalier Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256371
- Sponsor's protocol ID
- P130604
- Acronym
- PSYCNEP
- Status last verified
- Jul 2021
- First submitted
- 1 Oct 2014
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study
- ClinicalTrials.gov ID
- NCT02256371
- Acronym / sponsor ID
- PSYCNEP / P130604
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic pain, Hypnosis, Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized double-blind controlled two centers study. The primary objective of this study will be to show a superiority of hypnosis over relaxation on pain intensity in patients with neuropathic pain.
Detailed description
The secondary objectives of this study are:
- to show a superiority of hypnosis and relaxation over control group on neuropathic pain.
- to show a lasting effect of treatment on neuropathic pain one week after the end of treatment.
- to evaluate the clinical predictors of response to hypnosis (nature of neuropathic symptoms, severity of anxiety and depressive symptoms, pain catastrophizing, coping strategies, emotional regulation, response to the first session, positive or negative emotional reaction at the end of hypnosis sessions).
- to evaluate the effect of hypnosis at long-term (1, 3 and 6 months after the end of treatment).
- to evaluate the effect of hypnosis on emotional processes.
- to compare hypnosis to relaxation on short-term effects on pain,
- to evaluate the quality of life and the impact of pain on daily life: sleep, mood, anxiety symptoms, analgesics consumption , neuropathic symptoms, affective component of pain and pain catastrophizing. 35 patients will be enrolled in each arm, to obtain 105 in total (3 arms). Total duration for each patient: 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypnotic analgesia | Experimental | Behavioral: Hypnosis sessionsHypnosis sessions: Hypnosis will consist of 45 minutes hypnosis session with a trained hypnotherapist |
| Relaxation | Experimental | Behavioral: Relaxation groupRelaxation group: Relaxation will be conducted in 45 minutes sessions with a trained psychotherapist. |
| Routine care | No intervention | –The patients will receive their usual pain treatments throughout the study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- peripheral or central neuropathic pain, probable or definite
- Diagnostic questionnaire score DN4 ≥ 4/10
- Chronic Pain with an average of pain intensity greater than or equal to 4/10 (digital scale)
- Presence of daily or almost daily pain (i.e. at least 4 days per week)
- Patient with pre-existing pain for > 6 months
Key exclusion criteria (16 listed)
- Prior treatment with hypnosis
- Currently under active psychotherapy (Cognitive-Behavior Therapy, psychoanalysis)
- Work accident or litigation
- Drugs abuse or Psychoactive Substance Abuse (DSM-IV)
- Neuropathic pain associated with progressive disease (MS, HIV, cancer ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis sessions1 session per week during 8 weeks | Behavioural | Hypnotic analgesia |
| Relaxation group1 relaxation session per week during 8 weeks | Behavioural | Relaxation |
Primary outcome
Weekly mean pain intensity in patients diaries
Time frame: 9 week
The pain intensity score will be recorded daily by each patient on a self-assessment diary using a scale of 0 to 10. The record will begin from the first session of hypnosis or relaxation to the last session (S1 to S9).
13 secondary outcomes
Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment
Time frame: 8 months
Evaluation of the feeling of comfort and relaxation
Time frame: 9 weeks
Affective components of pain
Time frame: 8 months
Emotional processes and Alexithymia
Time frame: 8 months
Neuropathic symptoms (NPSI)
Time frame: 8 months
Interference with pain (Brief Pain Inventory)
Time frame: 8 months
Quality of life assessment
Time frame: 8 months
Depression and anxiety
Time frame: 8 months
Emotional distress caused by pain
Time frame: 8 months
Pain catastrophizing
Time frame: 9 months
Pain relief
Time frame: 8 months
Delay of onset of analgesic effects
Time frame: 8 weeks
Percentage of responders
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine ATTAL, MD, PhD principal investigator
Groupe Hospitalier Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis sessions and Relaxation group in people with Neuropathic Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly mean pain intensity in patients diaries (time frame: 9 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.