Knee OsteoarthritisArthroTENSNCT03902340
Comparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments.
A study testing ActiTENS and Level 2 Analgesic Treatments in people with Knee Osteoarthritis, run by Sublimed at 1 site in France.
Trial summary
This is a phase 3, multicentre, prospective, single-blind on principal efficacy criterion, 2 parallel groups, randomized, controlled clinical study comparing efficacy and safety of actiTENS versus systemic level 2 analgesics recommended for the treatment of moderate or severe, nociceptive, chronic pain in patients… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ActiTENS and Level 2 Analgesic Treatments
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2018to 31 Oct 2019
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult > or = 55 years.
- Being monitored by a rheumatologist in private practice or in a hospital.
- Presenting nociceptive pain:
- chronic (for at least 3 months),
- secondary to knee osteoarthritis confirmed by x-ray: stage 2 and over according to Kellgren and Lawrence.
- Of moderate to severe intensity equal to or above 4 on a numerical scale of 0-10.
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- In a situation of analgesic therapy failure for level 1 analgesics:
- paracetamol and NSAIDS,
- Prescribed at therapeutic dose : 4 g/d of paracetamol and 1200 mg/d of ibuprofen or equivalent (analgesic dose),
- For at least 2 weeks,
- Requiring a level 2 prescription.
- Affiliated to social security insurance.
- Informed of the concept and agreeing to use the TENS as a non-medicinal analgesic treatment.
- Capable of understanding how to use the TENS and the level 2 analgesic treatments.
- Intellectually and physically able to participate in the study in the opinion of the investigator.
- Owns a Smartphone to be able to download the actiTENS application.
Who cannot join
- Current or previous allergy to the actiTENS electrodes.
- On-going or planned pregnancy and absence of effective contraception (except for menopausal women).
- Neuropathic pain with a DN4 result > 4/10 or with a positive response to one or more questions in the DN4 clinical examination.
- Osteoarthritis flare.
- Surgery planned in the following 6 months.
- History of multiple operations on the knee concerned.
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- Medicinal or non-medicinal treatments which could influence the pathology being studied.
- Modification of medicinal or non-medicinal treatments planned in the following 6 months.
- Current participation in another study.
- Presence of another painful condition which could perturb the evaluation.
- Patient with an absolute contraindication to TENS or level 2 systemic analgesic treatments recommended for the treatment of chronic pain of moderate or severe intensity.
- Patient unable to express his/her consent or deprived of liberty.
- Patient with cognitive disorder or behaviour rendering him/her unsuitable to follow the instructions for this study.
- Patient not affiliated to a social security system.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Roger Salengro
Lille
Bernard Cortet, PhD, MD
About this study
Official title: Multicentre, Phase 3, Prospective Study With On-line Randomization, in Single Blind Conditions for the Primary Efficacy Endpoint, Controlled, in Two Parallel Groups, Comparing the Efficacy, Tolerability and Safety of actiTENS Versus Level 2 Systemic Analgesics Recommended for the Treatment of Chronic Nociceptive Pain of Moderate to Severe Intensity in Patients Suffering From Osteoarthritis of the Knee
This is a phase 3, multicentre, prospective, single-blind on principal efficacy criterion, 2 parallel groups, randomized, controlled clinical study comparing efficacy and safety of actiTENS versus systemic level 2 analgesics recommended for the treatment of moderate or severe, nociceptive, chronic pain in patients suffering from osteoarthritis of the knee.
Read the detailed description
Osteoarthritis (OA) is a debilitating chronic condition requiring long-term treatment of pain and inducing functional impairment. More specifically knee osteoarthritis (KOA) is a common disease associated with significant morbidity. Its prevalence increases with age dramatically. KOA is frequently associated with pain which can worsen with daily activities. The goals of KOA treatments are to provide pain relief and to improve function and quality of life. For the American college of Rheumatology and despite the frequent use of TENS in treating patients with KOA, questions remained regarding its efficacy. Consequently TENS needs additional clinical studies to demonstrate its efficacy in management of painful osteoarthritis.
The main objective of this study is to demonstrate the efficacy and to the safety of TENS in the management of chronic, nociceptive pain in patient suffering from KOA.
- Conditions
- Knee Osteoarthritis
- Being tested
- ActiTENS, Level 2 Analgesic Treatments
- Keywords
- Pain, Knee osteoarthritis (KOA), Nociceptive pain, TENS, Step 2 analgesics
- Medical subject headings
- Osteoarthritis, Knee, Pain, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiTENSDevice
ActiTENS is a rechargeable box, weighing 64g attached by Velcro to an adhesive support, which can be positioned on the skin at any position chosen by the patient. The patient will use the programme (P4) prescribed by his doctor and will regulate the intensity of stimulation using an application downloaded to his smartphone which will communicate with the box via Bluetooth.
Level 2 Analgesic TreatmentsDrug
There are 4 level 2 oral analgesic treatments indicated for chronic nociceptive pain of moderate to severe intensity (between 4 and 7 on a simple numerical scale of 11 points) (12):
- Tramadol immediate release formulation (IR, one intake every 6 hours) or prolonged release formulation (PR, one intake every 12 hours); maximum posology 400mg/24h.
- Dihydrocodeine: 60mg every 12 hours; maximum posology 120mg/24h.
- Combination of paracetamol and codeine in a fixed combination every 6 hours; maximum posology of codeine: 300mg/24h.
- Combination of paracetamol and tramadol in a fixed combination; maximum posology of tramadol: 8 tablets/24h ie 300mg/24h.
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Treatment by non-pharmacological transcutaneous electric nerve stimulation (TENS) Receives: Device: ActiTENS |
| level 2 systemic analgesic treatments | Active comparator | Treatment by level 2 analgesic pharmacological treatment indicated in the treatment of chronic nociceptive pain of moderate to severe intensity. Receives: Drug: Level 2 Analgesic Treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10
Pain intensity (PI) at M3 between both treatment groups. Numerus scale with a minimum of 0 (no pain) to a maximum of 10 (maximum pain).
Measured: 3 months after dosing
Safety : occurence of adverse events
Number of adverse events (AE) occurred during the 3 months of follow-up and due to studied treatments.
Measured: 3 months after dosing
Secondary outcomes (10)
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10
Minimum, maximum,median and difference of pain intensity (PI) during movement and at rest at M1, M3 and M6 between both treatment groups
Measured: 1, 3 and 6 months after dosing
Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score)
Functional status (pain, function, stiffness) at M1, M3 and M6.
Measured: 1, 3 and 6 months after dosing
Efficacy : pain relief (PAR) evaluated by the pain visual analogue scale (VAS)
Pain relief at M1, M3 and M6. VAS from 0 to 10 with 0 = no relief and 10 = total relief). Scale of 100 mm.
Measured: 1, 3 and 6 months after dosing
Efficacy : quality of life evaluated by the questionnaire EuroQol-5D
Evaluation of the quality of life at M1, M3 and M6
Measured: 1, 3 and 6 months after dosing
Efficacy : patient global impression of change evaluated by a global impression questionnaire.
Evaluation of the change on activity, symptoms, emotions, quality of life regarding the pain of patient at M1, M3 and M6
Measured: 1, 3 and 6 months after dosing
Efficacy : drop-outs for inefficacy
Evaluation of the number of patient drop outs because of treatment inefficacy in each arm
Measured: Through study completion, an average of 6 months
Efficacy : prolongation of studied treatment
Evaluation of the number of patient wishes to continue the studied treatment.
Measured: Through study completion, an average of 6 months
Safety : occurrence of Adverse Events (AE)
Evaluation by the type of AE and the date of occurence
Measured: Through study completion, an average of 6 months
Safety : drop-outs for AE and corrective treatments
Evaluation of the number of patient drop outs because of the occurence of adverse events in each arm
Measured: Through study completion, an average of 6 months
Estimation of direct costs.
Comparison of treatment costs between the two arms
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start19 Dec 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sublimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Responsible party
- Sponsor
- Investigators
- Bernard CORTET, Pr, Principal investigator, Hôpital Roger Salengro - Service de Rhumatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902340
- Sponsor's protocol ID
- 2018-A01895-50
- Acronym
- ArthroTENS
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maheu E, Soriot-Thomas S, Noel E, Ganry H, Lespessailles E, Cortet B. Wearable transcutaneous electrical nerve stimulation (actiTENS(R)) is effective and safe for the treatment of knee osteoarthritis pain: a randomized controlled trial versus weak opioids. Ther Adv Musculoskelet Dis. 2022 Jan 18;14:1759720X211066233. doi: 10.1177/1759720X211066233. eCollection 2022.
PubMed 35069809
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Phase 3, Prospective Study With On-line Randomization, in Single Blind Conditions for the Primary Efficacy Endpoint, Controlled, in Two Parallel Groups, Comparing the Efficacy, Tolerability and Safety of actiTENS Versus Level 2 Systemic Analgesics Recommended for the Treatment of Chronic Nociceptive Pain of Moderate to Severe Intensity in Patients Suffering From Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03902340
- Acronym / sponsor ID
- ArthroTENS / 2018-A01895-50
- Conditions
- Knee Osteoarthritis
- Keywords
- Pain, Knee osteoarthritis (KOA), Nociceptive pain, TENS, Step 2 analgesics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- SublimedIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 4 Apr 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.
This is a phase 3, multicentre, prospective, single-blind on principal efficacy criterion, 2 parallel groups, randomized, controlled clinical study comparing efficacy and safety of actiTENS versus systemic level 2 analgesics recommended for the treatment of moderate or severe, nociceptive, chronic pain in patients suffering from osteoarthritis of the knee.
Detailed description
Osteoarthritis (OA) is a debilitating chronic condition requiring long-term treatment of pain and inducing functional impairment. More specifically knee osteoarthritis (KOA) is a common disease associated with significant morbidity. Its prevalence increases with age dramatically. KOA is frequently associated with pain which can worsen with daily activities. The goals of KOA treatments are to provide pain relief and to improve function and quality of life. For the American college of Rheumatology and despite the frequent use of TENS in treating patients with KOA, questions remained regarding its efficacy. Consequently TENS needs additional clinical studies to demonstrate its efficacy in management of painful osteoarthritis.
The main objective of this study is to demonstrate the efficacy and to the safety of TENS in the management of chronic, nociceptive pain in patient suffering from KOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: ActiTENSTreatment by non-pharmacological transcutaneous electric nerve stimulation (TENS) |
| level 2 systemic analgesic treatments | Active comparator | Drug: Level 2 Analgesic TreatmentsTreatment by level 2 analgesic pharmacological treatment indicated in the treatment of chronic nociceptive pain of moderate to severe intensity. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Adult > or = 55 years.
- Being monitored by a rheumatologist in private practice or in a hospital.
- Presenting nociceptive pain:
- Of moderate to severe intensity equal to or above 4 on a numerical scale of 0-10.
- In a situation of analgesic therapy failure for level 1 analgesics:
Key exclusion criteria (14 listed)
- Current or previous allergy to the actiTENS electrodes.
- On-going or planned pregnancy and absence of effective contraception (except for menopausal women).
- Neuropathic pain with a DN4 result > 4/10 or with a positive response to one or more questions in the DN4 clinical examination.
- Osteoarthritis flare.
- Surgery planned in the following 6 months.
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 |
|---|---|---|
| ActiTENSActiTENS is a rechargeable box, weighing 64g attached by Velcro to an adhesive support, which can be positioned on the skin at any position chosen by the patient. The patient will use the programme (P4) prescribed by his doctor and will regulate the intensity of stimulation using an application downloaded to his smartphone which will communicate with the box via Bluetooth. | Device | TENS |
| Level 2 Analgesic TreatmentsThere are 4 level 2 oral analgesic treatments indicated for chronic nociceptive pain of moderate to severe intensity (between 4 and 7 on a simple numerical scale of 11 points) (12): * Tramadol immediate release formulation (IR, one intake every 6 hours) or prolonged release formulation (PR, one intake every 12 hours); maximum posology 400mg/24h. * Dihydrocodeine: 60mg every 12 hours; maximum posology 120mg/24h. * Combination of paracetamol and codeine in a fixed combination every 6 hours; maximum posology of codeine: 300mg/24h. * Combination of paracetamol and tramadol in a fixed combination; maximum posology of tramadol: 8 tablets/24h ie 300mg/24h. | Drug | level 2 systemic analgesic treatments |
Primary outcome
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10
Time frame: 3 months after dosing
Pain intensity (PI) at M3 between both treatment groups. Numerus scale with a minimum of 0 (no pain) to a maximum of 10 (maximum pain).
Safety : occurence of adverse events
Time frame: 3 months after dosing
Number of adverse events (AE) occurred during the 3 months of follow-up and due to studied treatments.
10 secondary outcomes
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10
Time frame: 1, 3 and 6 months after dosing
Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score)
Time frame: 1, 3 and 6 months after dosing
Efficacy : pain relief (PAR) evaluated by the pain visual analogue scale (VAS)
Time frame: 1, 3 and 6 months after dosing
Efficacy : quality of life evaluated by the questionnaire EuroQol-5D
Time frame: 1, 3 and 6 months after dosing
Efficacy : patient global impression of change evaluated by a global impression questionnaire.
Time frame: 1, 3 and 6 months after dosing
Efficacy : drop-outs for inefficacy
Time frame: Through study completion, an average of 6 months
Efficacy : prolongation of studied treatment
Time frame: Through study completion, an average of 6 months
Safety : occurrence of Adverse Events (AE)
Time frame: Through study completion, an average of 6 months
Safety : drop-outs for AE and corrective treatments
Time frame: Through study completion, an average of 6 months
Estimation of direct costs.
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Derived from this study: PubMed 35069809Maheu E, Soriot-Thomas S, Noel E, Ganry H, Lespessailles E, Cortet B. Wearable transcutaneous electrical nerve stimulation (actiTENS(R)) is effective and safe for the treatment of knee osteoarthritis pain: a randomized controlled trial versus weak opioids. Ther Adv Musculoskelet Dis. 2022 Jan 18;14:1759720X211066233. doi: 10.1177/1759720X211066233. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Bernard CORTET, Pr principal investigator
Hôpital Roger Salengro - Service de Rhumatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiTENS and Level 2 Analgesic Treatments in people with Knee Osteoarthritis, run by Sublimed 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 16 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 4 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Abraham Briffod (+33 4 76 37 17 58, contact@subli-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10 (time frame: 3 months after dosing). 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?
On the ClinicalTrials.gov record for NCT03902340, which also lists 1 linked publication.
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 4 Apr 2019.