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Comparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments. (ArthroTENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902340
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Eurofins Optimed
Information provided by (Responsible Party):
Sublimed

Brief 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 suffering from osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: ActiTENS Drug: Level 2 Analgesic Treatments Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: TENS
Treatment by non-pharmacological transcutaneous electric nerve stimulation (TENS)
Device: ActiTENS
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.

Active Comparator: level 2 systemic analgesic treatments
Treatment by level 2 analgesic pharmacological treatment indicated in the treatment of chronic nociceptive pain of moderate to severe intensity.
Drug: Level 2 Analgesic Treatments

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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. Efficacy : pain intensity evaluated by a numerus scale from 0 to 10 [ Time Frame: 1, 3 and 6 months after dosing ]
    Minimum, maximum,median and difference of pain intensity (PI) during movement and at rest at M1, M3 and M6 between both treatment groups

  2. Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score) [ Time Frame: 1, 3 and 6 months after dosing ]
    Functional status (pain, function, stiffness) at M1, M3 and M6.

  3. Efficacy : pain relief (PAR) evaluated by the pain visual analogue scale (VAS) [ Time Frame: 1, 3 and 6 months after dosing ]
    Pain relief at M1, M3 and M6. VAS from 0 to 10 with 0 = no relief and 10 = total relief). Scale of 100 mm.

  4. Efficacy : quality of life evaluated by the questionnaire EuroQol-5D [ Time Frame: 1, 3 and 6 months after dosing ]
    Evaluation of the quality of life at M1, M3 and M6

  5. Efficacy : patient global impression of change evaluated by a global impression questionnaire. [ Time Frame: 1, 3 and 6 months after dosing ]
    Evaluation of the change on activity, symptoms, emotions, quality of life regarding the pain of patient at M1, M3 and M6

  6. Efficacy : drop-outs for inefficacy [ Time Frame: Through study completion, an average of 6 months ]
    Evaluation of the number of patient drop outs because of treatment inefficacy in each arm

  7. Efficacy : prolongation of studied treatment [ Time Frame: Through study completion, an average of 6 months ]
    Evaluation of the number of patient wishes to continue the studied treatment.

  8. Safety : occurrence of Adverse Events (AE) [ Time Frame: Through study completion, an average of 6 months ]
    Evaluation by the type of AE and the date of occurence

  9. Safety : drop-outs for AE and corrective treatments [ Time Frame: Through study completion, an average of 6 months ]
    Evaluation of the number of patient drop outs because of the occurence of adverse events in each arm

  10. Estimation of direct costs. [ Time Frame: Through study completion, an average of 6 months ]
    Comparison of treatment costs between the two arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902340


Contacts
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Contact: Patricia Abraham Briffod +33 4 76 37 17 58 contact@subli-med.com

Locations
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France
Hôpital Roger Salengro Recruiting
Lille, France
Contact: Bernard Cortet, PhD, MD         
Sponsors and Collaborators
Sublimed
Eurofins Optimed
Investigators
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Principal Investigator: Bernard CORTET, Pr Hôpital Roger Salengro - Service de Rhumatologie
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Responsible Party: Sublimed
ClinicalTrials.gov Identifier: NCT03902340    
Other Study ID Numbers: 2018-A01895-50
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sublimed:
Pain
Knee osteoarthritis (KOA)
Nociceptive pain
TENS
Step 2 analgesics
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Nociceptive Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs