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Completed

NCT Number: NCT01944150

Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis

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.

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Key information

Conditions

Limbs Arthrosis Autonomic Nervous System Diseases Cervical Radiculopathy Chronic Back Pain Chronic Lomboradiculalgia Chronic Pain Complex Regional Pain Syndrome Type I or II Complex Regional Pain Syndromes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Nociceptive Pain Non Arthrosic Limbs Arthralgia Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Post Trauma Neuropathic Pain Post-herpetic Neuralgia Post-surgical Peripheral Neuropathic Pain Radiculopathy Signs and Symptoms Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CETD - Hospital Saint-Antoine

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous electrical nerve stimulation

Behavioral

explanations about devices and their use are given to the patient during the first session. The right place where the electrodes should be placed on, the most effective programme (optimal electric frequency provided by the machine), intensity are tested by the nurse during 30 minutes lasting session

Transcutaneous electrical nerve stimulation and hypnosis

Behavioral

explanations about devices and their use are given to the patient during the first session. The right place where the electrodes should be placed on, the most effective programme (optimal electric frequency provided by the machine), intensity are tested by the nurse. Following informations are collected by the second nurse: pain representation and its relief thoughts about a quiet place. TENS and hypnosis are associated in a unique 30 minutes session

Primary outcomes

  1. Pain intensity

    Time frame: between the first visit and three months after the beginning of the strategy.

    The pain assessment is processed using a Visual Analog Scale (VAS), graduated from 0 to 100mm.

    The patient is asked to move a cursor on a line to reflect the severity of his/her pain. The left end indicates "no pain", the right one shows "the most intense pain you can imagine".

    On the other side, graduations are only seen by the caregiver. The pain intensity is read on this side, rated in millimetres.

Secondary outcomes

  1. the patient's observance with the different strategies using a pad.

    Time frame: from one week after the beginning of the strategy up to 6 months.

    Collections of the data (number and duration of TENS device uses) from the patient log book

  2. the consumption of analgesic

    Time frame: during 6 months.

    Collection of the concomitant treatments (processing) on the patient pad in every visit.

  3. the quality of life estimated by the patient using the scale(ladder) SF36 and estimating the impression(printing) of change of the patient using the PGIC scale(ladder)

    Time frame: at the first visit, one month, three and six months after the beginning of the strategy, except the scale QDSA, which is used one, three and six months later after the beginning of the strategy.

    These two scales are self-assessment, exploring physical, emotional and social health.

    They allow pain impact assessment or professional activities, leisure activities and everyday life.

    The final aim is to identify if patients could recover their usual activity faster in one arm of the study versus the other one.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Interest of the Association of Two Complementary Techniques, Hypnosis and Transcutaneous Electrical Nerve Stimulation in the Treatment of Chronic Non-cancer Pain, Nociceptive and / or Neuropathic Pain: Randomized Trial

Acronym: HYPTENS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2013
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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