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Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis (HYPTENS)

Primary Purpose

Limbs Arthrosis, Non Arthrosic Limbs Arthralgia, Chronic Lomboradiculalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation
Transcutaneous electrical nerve stimulation and hypnosis
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Limbs Arthrosis focused on measuring Hypnosis, chronic pain, transcutaneous electrical nerve stimulation, nociceptive pain, neuropathic pain, complementary therapies

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CETD - Hospital Saint-Antoine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TENS

TENS and hypnosis.

Arm Description

Patients with only transcutaneous electrical nerve stimulation (TENS),

Patients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously

Outcomes

Primary Outcome Measures

Pain intensity
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.
Collections of the data (number and duration of TENS device uses) from the patient log book
the consumption of analgesic
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)
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.

Full Information

First Posted
September 2, 2013
Last Updated
August 2, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01944150
Brief Title
Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis
Acronym
HYPTENS
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Hypnosis, chronic pain, transcutaneous electrical nerve stimulation, nociceptive pain, neuropathic pain, complementary therapies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS
Arm Type
Active Comparator
Arm Description
Patients with only transcutaneous electrical nerve stimulation (TENS),
Arm Title
TENS and hypnosis.
Arm Type
Experimental
Arm Description
Patients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously
Intervention Type
Behavioral
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Transcutaneous electrical nerve stimulation and hypnosis
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
between the first visit and three months after the beginning of the strategy.
Secondary Outcome Measure Information:
Title
the patient's observance with the different strategies using a pad.
Description
Collections of the data (number and duration of TENS device uses) from the patient log book
Time Frame
from one week after the beginning of the strategy up to 6 months.
Title
the consumption of analgesic
Description
Collection of the concomitant treatments (processing) on the patient pad in every visit.
Time Frame
during 6 months.
Title
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)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise GEOFFROY, Nurse
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CETD - Hospital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35579382
Citation
Smart KM, Ferraro MC, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2022 May 17;5(5):CD010853. doi: 10.1002/14651858.CD010853.pub3.
Results Reference
derived
PubMed Identifier
33783846
Citation
Tonye-Geoffroy L, Mauboussin Carlos S, Tuffet S, Fromentin H, Berard L, Leblanc J, Laroche F. Efficacy of a combination of hypnosis and transcutaneous electrical nerve stimulation for chronic non-cancer pain: A randomized controlled trial. J Adv Nurs. 2021 Jun;77(6):2875-2886. doi: 10.1111/jan.14833. Epub 2021 Mar 30.
Results Reference
derived

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Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis

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