Neuropathic PainQolTENSNCT03877016
Pilot Study in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
A study testing TENS in people with Neuropathic Pain, run by Centre Hospitalier Universitaire, Amiens at 5 sites in France.
Trial summary
Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesFrance
- Study dates
- 17 Sep 2019to 1 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Patient covered by national health insurance
- Patient able to express consent
- Patient with neuropathic pain with DN4 (Douleur Neuropathique 4 Questions) > or = 4/10.
- Actual or potential neurologic lesion
- Patient still using a TENS device
Who cannot join
- Planned surgery in the next two months
- Modification of the reatment in the next two motnhs
- Other study ongoing for the patient
- Medical contraindication for TENS
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Amiens Picardie
Amiens, 80000
CHD La Roche Sur Yon
La Roche-sur-Yon, 85000
CHU de Nantes
Nantes, 44093
APHP - Hopital Saint Antoine
Paris, 75571
CHU de Toulouse
Toulouse, 31059
About this study
Official title: Prospective, Multicentric, Randomized on Two Arms, Controlled, by Cross-over, Pilot Study, in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Unfortunately, the use of TENS by patients appears very difficult. Because of this inconvenience, more than 40% of TENS users interrupt the treatment despite treatment benefit. A new TENS device: actiTENS that seems to be less constraining than TENS is now available in France. ActiTENS efficacy and safety compared to TENS need to be investigated.
The main objective is to evaluate and to compare the use of actiTENS, with TENS Eco 2, the classical device in patients with chronic neuropathic pain.
- Conditions
- Neuropathic Pain
- Being tested
- TENS
- Keywords
- neuropathic pain, electrical nerve stimulation therapy, patient report outcomes, non-pharmalogical treatment
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSProcedure or surgery
TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation
| Study group | Role | What they receive |
|---|---|---|
| TENS Eco2 | Active comparator | TENS Eco2 is the classical device in patients with chronic neuropathic pain Receives: Procedure: TENS |
| actiTENS | Experimental | ActiTENS is a new TENS device, that seems less cotraining. Receives: Procedure: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Measured: day7 after patient inclusion
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Measured: day 35 after patient inclusion
Secondary outcomes (2)
length of TENS daily use
Length of TENS daily use
Measured: day7 after patient inclusion
length of TENS daily use
Length of TENS daily use
Measured: day 35 after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start17 Sep 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric SERRA, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877016
- Sponsor's protocol ID
- PI2018_843_0028
- Acronym
- QolTENS
- Status last verified
- Jan 2023
- First submitted
- 14 Mar 2019
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Randomized on Two Arms, Controlled, by Cross-over, Pilot Study, in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
- ClinicalTrials.gov ID
- NCT03877016
- Acronym / sponsor ID
- QolTENS / PI2018_843_0028
- Conditions
- Neuropathic Pain
- Keywords
- neuropathic pain, electrical nerve stimulation therapy, patient report outcomes, non-pharmalogical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 15 Mar 2019 (actual)
- 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.
Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Unfortunately, the use of TENS by patients appears very difficult. Because of this inconvenience, more than 40% of TENS users interrupt the treatment despite treatment benefit. A new TENS device: actiTENS that seems to be less constraining than TENS is now available in France. ActiTENS efficacy and safety compared to TENS need to be investigated.
The main objective is to evaluate and to compare the use of actiTENS, with TENS Eco 2, the classical device in patients with chronic neuropathic pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS Eco2 | Active comparator | Procedure: TENSTENS Eco2 is the classical device in patients with chronic neuropathic pain |
| actiTENS | Experimental | Procedure: TENSActiTENS is a new TENS device, that seems less cotraining. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult
- Patient covered by national health insurance
- Patient able to express consent
- Patient with neuropathic pain with DN4 (Douleur Neuropathique 4 Questions) > or = 4/10.
- Actual or potential neurologic lesion
Key exclusion criteria (4 listed)
- Planned surgery in the next two months
- Modification of the reatment in the next two motnhs
- Other study ongoing for the patient
- Medical contraindication for TENS
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 |
|---|---|---|
| TENSTENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation | Procedure or surgery | TENS Eco2, actiTENS |
Primary outcome
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Time frame: day7 after patient inclusion
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
Time frame: day 35 after patient inclusion
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
2 secondary outcomes
length of TENS daily use
Time frame: day7 after patient inclusion
length of TENS daily use
Time frame: day 35 after patient inclusion
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 25 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Neuropathic Pain
Not yet recruiting
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Neuropathic Pain, Chronic Pain
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
Recruiting
Post Operative Pain and Vagal Stimulation
Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic)
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.
Eric SERRA, MD principal investigator
CHU Amiens
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Neuropathic Pain, run by Centre Hospitalier Universitaire, Amiens at 5 sites 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 6 inclusion and 4 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS (time frame: day7 after patient inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2023.