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| ID | Type | Description | Link |
|---|---|---|---|
| PHRI120049 | Other Identifier | Assistance Publique |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS | Active Comparator | Patients with only transcutaneous electrical nerve stimulation (TENS), |
|
| TENS and hypnosis. | Experimental | Patients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical nerve stimulation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| the consumption of analgesic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise GEOFFROY, Nurse | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CETD - Hospital Saint-Antoine | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35579382 | Derived | 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. | |
| 33783846 | Derived | 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. |
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|
| Transcutaneous electrical nerve stimulation and hypnosis | 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 |
|
Collection of the concomitant treatments (processing) on the patient pad in every visit. |
| during 6 months. |
| 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. |
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D051474 | Neuralgia, Postherpetic |
| D020918 | Complex Regional Pain Syndromes |
| D052256 | Tendinopathy |
| D059350 | Chronic Pain |
| D059226 | Nociceptive Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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