Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis

Tendinopathy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944150
• Other study ID #: K121201
• Secondary ID: PHRI120049
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: August 2, 2017
• Start date: September 2013
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Back Pain
• Cervical Radiculopathy
• Chronic Back Pain
• Chronic Lomboradiculalgia
• Complex Regional Pain Syndrome Type I or II
• Complex Regional Pain Syndromes
• Limbs Arthrosis
• Neuralgia
• Neuralgia, Postherpetic
• Non Arthrosic Limbs Arthralgia
• Post Trauma Neuropathic Pain
• Post-herpetic Neuralgia
• Post-surgical Peripheral Neuropathic Pain
• Radiculopathy
• Reflex Sympathetic Dystrophy
• Tendinopathy

Intervention

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
• 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

Locations

Country	Name	City	State
France	CETD - Hospital Saint-Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	between the first visit and three months after the beginning of the strategy.
Secondary	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	from one week after the beginning of the strategy up to 6 months.
Secondary	the consumption of analgesic	Collection of the concomitant treatments (processing) on the patient pad in every visit.	during 6 months.
Secondary	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.	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.