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

NCT ID: NCT03902340

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2019-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TENS

Treatment by non-pharmacological transcutaneous electric nerve stimulation (TENS)

Group Type: EXPERIMENTAL

ActiTENS

Intervention Type: DEVICE

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 systemic analgesic treatments

Treatment by level 2 analgesic pharmacological treatment indicated in the treatment of chronic nociceptive pain of moderate to severe intensity.

Group Type: ACTIVE_COMPARATOR

Level 2 Analgesic Treatments

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins Optimed

INDUSTRY

Sponsor Role: collaborator

Sublimed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard CORTET, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Roger Salengro - Service de Rhumatologie

Locations

Hôpital Roger Salengro

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patricia Abraham Briffod

Role: CONTACT

contact@subli-med.com

+33 4 76 37 17 58

Facility Contacts

Bernard Cortet, PhD, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35069809 (View on PubMed)

Other Identifiers

2018-A01895-50

Identifier Type: -

Identifier Source: org_study_id