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

NCT03902340 | Unknown

• 1 other identifier: 2018-A01895-50
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Pain; Knee osteoarthritis (KOA); Nociceptive pain; TENS; Step 2 analgesics

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  3 months after dosing

Secondary Outcomes (10)

• Efficacy : pain intensity evaluated by a numerus scale from 0 to 10

  1, 3 and 6 months after dosing

• Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score)

  1, 3 and 6 months after dosing

• Efficacy : pain relief (PAR) evaluated by the pain visual analogue scale (VAS)

  1, 3 and 6 months after dosing

• Efficacy : quality of life evaluated by the questionnaire EuroQol-5D

  1, 3 and 6 months after dosing

• Efficacy : patient global impression of change evaluated by a global impression questionnaire.

  1, 3 and 6 months after dosing

Study Arms (2)

TENS

EXPERIMENTAL

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

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.

Drug: Level 2 Analgesic Treatments

Interventions

ActiTENS 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.

TENS

Level 2 Analgesic Treatments 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.

level 2 systemic analgesic treatments

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sublimed: lead
• Eurofins Optimed: collaborator

Study Sites (1)

Hôpital Roger Salengro

Lille, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35069809 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Nociceptive Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard CORTET, Pr

  Hôpital Roger Salengro - Service de Rhumatologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Abraham Briffod

CONTACT

+33 4 76 37 17 58; contact@subli-med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 4, 2019
• Study Start: December 19, 2018
• Primary Completion: June 30, 2019
• Study Completion: October 31, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)