Limbs ArthrosisHYPTENSNCT01944150
Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis
A study testing Transcutaneous electrical nerve stimulation and Transcutaneous electrical nerve stimulation and hypnosis in people with Limbs Arthrosis and Non Arthrosic Limbs Arthralgia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Limbs Arthrosis, Non Arthrosic Limbs Arthralgia, Chronic Lomboradiculalgia
- What is being tested?
- Transcutaneous electrical nerve stimulation and Transcutaneous electrical nerve stimulation and hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Limbs Arthrosis, Non Arthrosic Limbs Arthralgia, Chronic Lomboradiculalgia, Chronic Back Pain, Cervical Radiculopathy, Post-herpetic Neuralgia
- Being tested
- Transcutaneous electrical nerve stimulation, Transcutaneous electrical nerve stimulation and hypnosis
- Keywords
- Hypnosis, chronic pain, transcutaneous electrical nerve stimulation, nociceptive pain, neuropathic pain, complementary therapies
- Medical subject headings
- Radiculopathy, Neuralgia, Postherpetic, Complex Regional Pain Syndromes, Tendinopathy, Chronic Pain, Nociceptive Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationBehavioural
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 hypnosisBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| TENS | Active comparator | Patients with only transcutaneous electrical nerve stimulation (TENS), Receives: Behavioral: Transcutaneous electrical nerve stimulation |
| TENS and hypnosis. | Experimental | Patients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously Receives: Behavioral: Transcutaneous electrical nerve stimulation and hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between the first visit and three months after the beginning of the strategy.
Secondary outcomes (3)
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
Measured: from one week after the beginning of the strategy up to 6 months.
the consumption of analgesic
Collection of the concomitant treatments (processing) on the patient pad in every visit.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Limbs ArthrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise GEOFFROY, Nurse, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944150
- Sponsor's protocol ID
- K121201
- Other IDs
- PHRI120049
- Acronym
- HYPTENS
- Status last verified
- Aug 2017
- First submitted
- 2 Sep 2013
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35579382Tonye-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.
PubMed 33783846
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01944150
- Acronym / sponsor ID
- HYPTENS / K121201
- Conditions
- Limbs Arthrosis, Non Arthrosic Limbs Arthralgia, Chronic Lomboradiculalgia, Chronic Back Pain, Cervical Radiculopathy, Post-herpetic Neuralgia
- Keywords
- Hypnosis, chronic pain, transcutaneous electrical nerve stimulation, nociceptive pain, neuropathic pain, complementary therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Active comparator | Behavioral: Transcutaneous electrical nerve stimulationPatients with only transcutaneous electrical nerve stimulation (TENS), |
| TENS and hypnosis. | Experimental | Behavioral: Transcutaneous electrical nerve stimulation and hypnosisPatients with transcutaneous electrical nerve stimulation (TENS) and hypnosis simultaneously |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical nerve stimulationexplanations 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 | Behavioural | TENS |
| Transcutaneous electrical nerve stimulation and hypnosisexplanations 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 | Behavioural | TENS and hypnosis. |
Primary outcome
Pain intensity
Time frame: 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.
3 secondary outcomes
the patient's observance with the different strategies using a pad.
Time frame: from one week after the beginning of the strategy up to 6 months.
the consumption of analgesic
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Derived from this study: PubMed 35579382Smart 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.
- Derived from this study: PubMed 33783846Tonye-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise GEOFFROY, Nurse principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation and Transcutaneous electrical nerve stimulation and hypnosis in people with Limbs Arthrosis and Non Arthrosic Limbs Arthralgia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: between the first visit and three months after the beginning of the strategy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944150, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.