Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-29 @ 11:50 AM
Study NCT ID:
NCT01944150
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2013-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPTENS
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PHRI120049 | OTHER | Assistance Publique | View |