Back to resultsComparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments. (ArthroTENS)
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ActiTENS
Level 2 Analgesic Treatments
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Pain, Knee osteoarthritis (KOA), Nociceptive pain, TENS, Step 2 analgesics
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.
Sites / Locations
- Hôpital Roger SalengroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TENS
level 2 systemic analgesic treatments
Arm Description
Treatment by non-pharmacological transcutaneous electric nerve stimulation (TENS)
Treatment by level 2 analgesic pharmacological treatment indicated in the treatment of chronic nociceptive pain of moderate to severe intensity.
Outcomes
Primary Outcome Measures
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).
Safety : occurence of adverse events
Number of adverse events (AE) occurred during the 3 months of follow-up and due to studied treatments.
Secondary Outcome Measures
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
Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score)
Functional status (pain, function, stiffness) at M1, M3 and M6.
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.
Efficacy : quality of life evaluated by the questionnaire EuroQol-5D
Evaluation of the quality of life at M1, M3 and M6
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
Efficacy : drop-outs for inefficacy
Evaluation of the number of patient drop outs because of treatment inefficacy in each arm
Efficacy : prolongation of studied treatment
Evaluation of the number of patient wishes to continue the studied treatment.
Safety : occurrence of Adverse Events (AE)
Evaluation by the type of AE and the date of occurence
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
Estimation of direct costs.
Comparison of treatment costs between the two arms
Full Information
NCT ID
NCT03902340
First Posted
March 29, 2019
Last Updated
April 2, 2019
Sponsor
Sublimed
Collaborators
Eurofins Optimed
1. Study Identification
Unique Protocol Identification Number
NCT03902340
Brief Title
Comparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments.
Acronym
ArthroTENS
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sublimed
Collaborators
Eurofins Optimed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Pain, Knee osteoarthritis (KOA), Nociceptive pain, TENS, Step 2 analgesics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TENS
Arm Type
Experimental
Arm Description
Treatment by non-pharmacological transcutaneous electric nerve stimulation (TENS)
Arm Title
level 2 systemic analgesic treatments
Arm Type
Active Comparator
Arm Description
Treatment by level 2 analgesic pharmacological treatment indicated in the treatment of chronic nociceptive pain of moderate to severe intensity.
Intervention Type
Device
Intervention Name(s)
ActiTENS
Intervention Description
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
Drug
Intervention Name(s)
Level 2 Analgesic Treatments
Intervention Description
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 Measure Information:
Title
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10
Description
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).
Time Frame
3 months after dosing
Title
Safety : occurence of adverse events
Description
Number of adverse events (AE) occurred during the 3 months of follow-up and due to studied treatments.
Time Frame
3 months after dosing
Secondary Outcome Measure Information:
Title
Efficacy : pain intensity evaluated by a numerus scale from 0 to 10
Description
Minimum, maximum,median and difference of pain intensity (PI) during movement and at rest at M1, M3 and M6 between both treatment groups
Time Frame
1, 3 and 6 months after dosing
Title
Efficacy : functional status evaluated by the WOMAC score (Western Onatario McMaster score)
Description
Functional status (pain, function, stiffness) at M1, M3 and M6.
Time Frame
1, 3 and 6 months after dosing
Title
Efficacy : pain relief (PAR) evaluated by the pain visual analogue scale (VAS)
Description
Pain relief at M1, M3 and M6. VAS from 0 to 10 with 0 = no relief and 10 = total relief). Scale of 100 mm.
Time Frame
1, 3 and 6 months after dosing
Title
Efficacy : quality of life evaluated by the questionnaire EuroQol-5D
Description
Evaluation of the quality of life at M1, M3 and M6
Time Frame
1, 3 and 6 months after dosing
Title
Efficacy : patient global impression of change evaluated by a global impression questionnaire.
Description
Evaluation of the change on activity, symptoms, emotions, quality of life regarding the pain of patient at M1, M3 and M6
Time Frame
1, 3 and 6 months after dosing
Title
Efficacy : drop-outs for inefficacy
Description
Evaluation of the number of patient drop outs because of treatment inefficacy in each arm
Time Frame
Through study completion, an average of 6 months
Title
Efficacy : prolongation of studied treatment
Description
Evaluation of the number of patient wishes to continue the studied treatment.
Time Frame
Through study completion, an average of 6 months
Title
Safety : occurrence of Adverse Events (AE)
Description
Evaluation by the type of AE and the date of occurence
Time Frame
Through study completion, an average of 6 months
Title
Safety : drop-outs for AE and corrective treatments
Description
Evaluation of the number of patient drop outs because of the occurence of adverse events in each arm
Time Frame
Through study completion, an average of 6 months
Title
Estimation of direct costs.
Description
Comparison of treatment costs between the two arms
Time Frame
Through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Abraham Briffod
Phone
+33 4 76 37 17 58
Email
contact@subli-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard CORTET, Pr
Organizational Affiliation
Hôpital Roger Salengro - Service de Rhumatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard Cortet, PhD, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35069809
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments.
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