Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis

Not Applicable

Completed

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

• Registration Number: NCT01944150
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Primary Completion: 2017-02
• Study Completion: 2017-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS	Transcutaneous electrical nerve stimulation	Patients with only transcutaneous electrical nerve stimulation (TENS),
TENS and hypnosis.	Transcutaneous electrical nerve stimulation and hypnosis	Patients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously

Primary Outcome Measures

Name	Time	Method
Pain intensity	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 Outcome Measures

Name	Time	Method
the patient's observance with the different strategies using a pad.	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 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)	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.
the consumption of analgesic	during 6 months.	Collection of the concomitant treatments (processing) on the patient pad in every visit.

Trial Locations

Locations (1)

CETD - Hospital Saint-Antoine; 🇫🇷 Paris, France