Clinical trial NCT01944150: Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: between the first visit and three months after the beginning of the strategy.
Secondary outcomes:
measure: the patient's observance with the different strategies using a pad.
timeFrame: from one week after the beginning of the strategy up to 6 months.
measure: the consumption of analgesic
timeFrame: during 6 months.
measure: 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)
timeFrame: 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.
Other outcomes:
Locations:
city: Paris
country: France
facility: CETD - Hospital Saint-Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Louise GEOFFROY, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.