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Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis (HYPTENS)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Post Trauma Neuropathic Pain
Complex Regional Pain Syndrome Type I or II
Chronic Back Pain
Post-surgical Peripheral Neuropathic Pain
Post-herpetic Neuralgia
Chronic Lomboradiculalgia
Cervical Radiculopathy
Non Arthrosic Limbs Arthralgia
Tendinopathy
Limbs Arthrosis

Treatments

Behavioral: Transcutaneous electrical nerve stimulation
Behavioral: Transcutaneous electrical nerve stimulation and hypnosis

Study type

Interventional

Funder types

Other

Identifiers

NCT01944150
PHRI120049 (Other Identifier)
K121201

Details and patient eligibility

About

At Saint-Antoine's hospital, in CETD a multidisciplinary team takes care of patients with chronic pain. Free-drug techniques are available to reduce their consumption of analgesics. This study is to assess the relief obtained by the simultaneous combination of these two techniques: transcutaneous electrical nerve stimulation and hypnosis.

Full description

In the pain management centers, patients with chronic pain are supported by a multidisciplinary team. To optimize and reduce drug intake of analgesics, additional techniques (hypnosis, relaxation, cognitive behavioral therapy) and non-drug practices (transcutaneous electrical nerve stimulation) are offered to patients.

These techniques are most frequently performed by nurses and are used either separately or successively. The time interval during what the patient could expect pain relief is not known.

The hypothesis of the study is that simultaneous practice of two complementary therapies (transcutaneous electrical nerve stimulation (TENS) + hypnosis) decreases the intensity of pain in patients with chronic no cancer pain, nociceptive and/or neuropathic pain compared to practice of only one complementary therapy (TENS).

This study is an open randomized trial, comparative in two parallel groups (TENS versus TENS and hypnosis).

Trial design will be explained by the pain management center doctor. Inclusion and randomization performed by the nurse: group with TENS/group with TENS and hypnosis.

The patients will be followed up 8 times between day 0 and day180. Patients benefit from eight visits from day 0th to day 180th. Evaluations are EVA at each visit, SF36 questionnaires and score PGIC at one month, three and six months after the beginning of the strategy.

Enrollment

72 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients from 18 to 80 years suffering from chronic no cancer pain either nociceptive or neuropathic.
  • The treated skin must not be wounded
  • The patients must be able to comply with the requirement of the trial; they also need to express no objection to participate to this trial.
  • Patient with social security

Exclusion criteria

  • Patients with fibromyalgia, or having relaxation therapy sessions, acupuncture, cognitive and behavioral therapies
  • Patients with cognitive disorders, an unaided hearing loss, a major hearing impairment, carrying a pace maker, having an allodynia or a complete anesthesia of the painful territory, a large spreader painful territory
  • Sessions TENS practiced for analgesic by a professional within 3 years prior to inclusion, for the same pain (same features, same location)
  • Renting at home a TENS device within 3 years prior to inclusion for analgesic
  • Prior therapeutic care by hypnosis
  • pregnant woman or having a desire of pregnancy

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

TENS
Active Comparator group
Description:
Patients with only transcutaneous electrical nerve stimulation (TENS),
Treatment:
Behavioral: Transcutaneous electrical nerve stimulation
TENS and hypnosis.
Experimental group
Description:
Patients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously
Treatment:
Behavioral: Transcutaneous electrical nerve stimulation and hypnosis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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