Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis (HYPTENS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01944150
First received: September 2, 2013
Last updated: December 29, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Limbs Arthrosis
Non Arthrosic Limbs Arthralgia
Chronic Lomboradiculalgia
Chronic Back Pain
Cervical Radiculopathy
Post-herpetic Neuralgia
Post-surgical Peripheral Neuropathic Pain
Post Trauma Neuropathic Pain
Complex Regional Pain Syndrome Type I or II
Tendinopathy
Behavioral: Transcutaneous electrical nerve stimulation
Behavioral: Transcutaneous electrical nerve stimulation and hypnosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: between the first visit and three months after the beginning of the strategy. ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Collections of the data (number and duration of TENS device uses) from the patient log book

  • the consumption of analgesic [ Time Frame: during 6 months. ] [ Designated as safety issue: No ]
    Collection of the concomitant treatments (processing) on the patient pad in every visit.

  • 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. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 72
Study Start Date: September 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TENS
Patients with only transcutaneous electrical nerve stimulation (TENS),
Behavioral: Transcutaneous electrical nerve stimulation
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
Experimental: TENS and hypnosis.
Patients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously
Behavioral: Transcutaneous electrical nerve stimulation and hypnosis
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 or already been treated by TENS and/or hypnosis
  • pregnant woman or having a desire of pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944150

Contacts
Contact: Louise GEOFFROY, Nurse +33 (0)149 28 23 09 ide.emdsp@sat.aphp.fr
Contact: Stéphanie MAUBOUSSIN-CARLOS, Nurse +33 (0)149 28 23 09 ide.emdsp@sat.aphp.fr

Locations
France
CETD - Hospital Saint-Antoine Recruiting
Paris, France, 75012
Contact: Louise GEOFFROY, Nurse    +33 (0)149 28 23 09    ide.emdsp@sat.aphp.fr   
Contact: Stéphanie MAUBOUSSIN-CARLOS, Nurse    +33 (0)149 28 23 09    ide.emdsp@sat.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Louise GEOFFROY, Nurse Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01944150     History of Changes
Other Study ID Numbers: K121201, PHRI120049
Study First Received: September 2, 2013
Last Updated: December 29, 2013
Health Authority: France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hypnosis
chronic pain
transcutaneous electrical nerve stimulation
nociceptive pain
neuropathic pain
complementary therapies

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Neuralgia
Radiculopathy
Tendinopathy
Arthralgia
Neuralgia, Postherpetic
Reflex Sympathetic Dystrophy
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Autonomic Nervous System Diseases
Joint Diseases

ClinicalTrials.gov processed this record on September 16, 2014