Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis (HYPTENS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01944150|
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : August 3, 2017
|Condition or disease||Intervention/treatment|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Actual Study Start Date :||September 2013|
|Primary Completion Date :||February 2017|
|Study Completion Date :||May 2017|
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
- 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.
- 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
- the consumption of analgesic [ Time Frame: during 6 months. ]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. ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944150
|CETD - Hospital Saint-Antoine|
|Paris, France, 75012|
|Principal Investigator:||Louise GEOFFROY, Nurse||Assistance Publique - Hôpitaux de Paris|