Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design

NCT01896453

Chronic Low Back Pain

COMPLETED PHASE2/PHASE3

Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain

NCT05984329

Neuropathic Pain

COMPLETED

Cryotherapy and TENS on Low Back Pain

NCT03248505

Low Back Pain, Mechanical

UNKNOWN NA

Effects of Electrotherapy on Pain, Anxiety, Motion and Disability in Adults With Neck or Upper Body Pain.

NCT05382039

Chronic Pain

COMPLETED NA

Effectiveness Analysis of Ultrasound-guided Intratissue Percutaneous Electrolysis (EPI) in Patient With Chronic Low Back Pain

NCT04290221

Chronic Low-back Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TENS

Patients with only transcutaneous electrical nerve stimulation (TENS),

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type BEHAVIORAL

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

TENS and hypnosis.

Patients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously

Group Type EXPERIMENTAL

Transcutaneous electrical nerve stimulation and hypnosis

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No