Chronic PainIPATENSNCT04253639
Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain
An observational study of Chronic Pain, run by Sublimed.
Trial summary
This is a retrospective and transverse multicenter study to identify predictive factors for adherence to TENS by chronic pain patients followed in structures specialized in Chronic Pain management (SPC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Questionnaires
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Oct 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population studied is all adult chronic pain patients, who have benefited from an initiation of treatment with TENS dating back at least 6 months within a centre specialized in chronic pain management identified and labeled by a local regulatory agency. Patients who agree to participate in the study will be recruited in reverse chronological order from the list of patients in the active queue of each centre. Ten patients will be recruited by each investigator with a total of 50 centers.
Who may be able to join
- Aged 18 and over when TENS was implemented.
- Suffering from chronic pain.
- Follow-up in nurse consultation within a centre specialized in chronic pain management identified and labeled by a local regulatory agency.
- Benefiting from the implementation of TENS for more than 6 months by a nurse from a centre specialized in chronic pain management.
- Affiliate or Beneficiary of a health insurance scheme.
- For patients in the study population: Having expressed their non-opposition to participate in the study.
Show all 14Show fewer
- Patient used to verify the representativeness of the population studied: Unable to be contacted by phone and not having expressed their refusal to participate or for which the mail has not returned undelivered
- Non-inclusion criteria
- Minor.
- Major incapable to oppose to the use of their data during the study due to medical or legal decision.
- Having language impairment.
- Having difficulties understanding the French language.
- Unable to participate in the phone survey.
- Not affiliated with Health Insurance / Social Security.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
This is a retrospective and transverse multicenter study to identify predictive factors for adherence to TENS by chronic pain patients followed in structures specialized in Chronic Pain management (SPC).
The study contains 2 parts:
- A retrospective part of data collection in the patient follow-up file of the SPC during the 6 months elapsed after the first rental prescription.
- A transversal part, aimed at collecting additional information on the use of TENS, satisfaction and quality of life during a telephone interview after 6 months of use.
- Conditions
- Chronic Pain
- Being tested
- Questionnaires
- Keywords
- TENS, Predictive factors, Compliance, Chronic pain
- Medical subject headings
- Chronic Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Patients must fill questionnaires to collect socio-demographics, aetiology and characteristics of pain, efficacy and tolerance regarding the TENS.
Study sites must fill questionnaires to collect information regarding the type of pain management centre, the characteristics of the clinician, the characteristics of the TENS prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain patients | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of predictive factors explaining compliance to TENS.
Compliance is evaluated on a 6 month period prior to the inclusion. Compliant patients to TENS are defined as having 0, 1 or 2 to score of Morisky Medication Adherence Scale. Factors which can explain the lack of compliance will be collected and categorized within "pain centre", "clinician", "TENS characteristics", "patient socio-demographics", "aetiology and characteristics of pain", "efficacy and tolerance" data.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient
Secondary outcomes (14)
Efficacy parameters: follow up visits
Efficacy parameters: Rate of patients followed at 1, 3 and 6 months after the initiation session to TENS and rate and time of premature discontinuation of treatment.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: T1month, T3month, T6month
Efficacy parameters: observance
Rate of observant patients at 1, 3 and 6 months after the TENS initiation session.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: T1month, T3month, T6month
Efficacy parameters: pain intensity
Pain intensity (PI) collected using an 11 point digital scale (EN) (0 - 10, 0 = no pain; 10 = maximum pain imaginable) during the first contact with the investigator/nurse (D0) (patient record), then 1, 3 and 6 months after the TENS initiation session (patient record) and during the 8 days preceding the last use of TENS.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: Pain intensity differences
Pain intensity differences (PID) on the average intensity scores at 1, 3 and 6 months after the TENS initiation session and during the 8 days preceding the last use of TENS (PI inclusion - PI T-time).
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: Sum of Pain intensity differences
Sum of pain intensity differences (SPID) on the average intensity scores at 1, 3 and 6 months after the TENS initiation session and during the 8 days preceding the last use of TENS, weighted on the time factor: SPID0-Xmonth = Σ [T (i) -T (i-1)] xPID (i).
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: punctual relief
Relief (PAR) using an 11-point numeric scale (0% -100%, 0 = no relief; 100% = complete relief) at 1, 3 and 6 months (patient record) after the introduction to TENS and during the 8 days preceding the last use of TENS.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: Total relief
Total relief (TOTPAR) or TOTPARt0-tx = Σ [T (x) -T (x-1)] xPAR (x) when T (0) = 0, T (x) is the selected evaluation time and PAR (x) is the PAR value at the times 1, 3 and 6 months after the TENS initiation session and during the 8 days preceding the last use of the TENS
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: Quality of life
Quality of life questionnaire (EQ-5D) when TENS was last used.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
Efficacy parameters: Impression of change
Patients' Global Impression of Change (PGIC) when the TENS was last used.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
Efficacy parameters: Satisfaction
Satisfaction when TENS was last used.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
Efficacy parameters: wish for continuation
Number of patients wishing to continue treatment and purchase the device
Measured: Data are collected the day of the inclusion.
Mode of use of the TENS
For each of the 4 TENS allowed in the study, description of the program used and collection of the duration of use, the number of sessions per day and the duration of the post-effect as well as compliance with the instructions for use of the TENS during follow-up.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
Tolerance parameters: AEs
Number, delay of onset and type of serious and non-serious AEs (SAEs) occurring during the 6 months of follow-up and attributable, according to the opinion of the investigator, to treatment.
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
Tolerance parameters: premature discontinuation
Number of premature discontinuations before 6 months for tolerance problems
Measured: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sublimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muriel PERRIOT MOREY, Principal investigator, Chateauroux hospital - Pain managment center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253639
- Sponsor's protocol ID
- IPATENS
- Acronym
- IPATENS
- Status last verified
- Jan 2020
- First submitted
- 31 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Factors for observAnce of Transcutaneous Electrical NeuroStimulation (TENS) in Chronic Pain
- ClinicalTrials.gov ID
- NCT04253639
- Acronym / sponsor ID
- IPATENS / IPATENS
- Conditions
- Chronic Pain
- Keywords
- TENS, Predictive factors, Compliance, Chronic pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- SublimedIndustry (pharma, biotech, devices)
- Study start
- Mar 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 5 Feb 2020 (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 retrospective and transverse multicenter study to identify predictive factors for adherence to TENS by chronic pain patients followed in structures specialized in Chronic Pain management (SPC).
The study contains 2 parts:
- A retrospective part of data collection in the patient follow-up file of the SPC during the 6 months elapsed after the first rental prescription.
- A transversal part, aimed at collecting additional information on the use of TENS, satisfaction and quality of life during a telephone interview after 6 months of use.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain patients | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied is all adult chronic pain patients, who have benefited from an initiation of treatment with TENS dating back at least 6 months within a centre specialized in chronic pain management identified and labeled by a local regulatory agency. Patients who agree to participate in the study will be recruited in reverse chronological order from the list of patients in the active queue of each centre. Ten patients will be recruited by each investigator with a total of 50 centers.
Key inclusion criteria (14 listed)
- Aged 18 and over when TENS was implemented.
- Suffering from chronic pain.
- Follow-up in nurse consultation within a centre specialized in chronic pain management identified and labeled by a local regulatory agency.
- Benefiting from the implementation of TENS for more than 6 months by a nurse from a centre specialized in chronic pain management.
- Affiliate or Beneficiary of a health insurance scheme.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| QuestionnairesPatients must fill questionnaires to collect socio-demographics, aetiology and characteristics of pain, efficacy and tolerance regarding the TENS. Study sites must fill questionnaires to collect information regarding the type of pain management centre, the characteristics of the clinician, the characteristics of the TENS prescribed. | Other | Chronic pain patients |
Primary outcome
Determination of predictive factors explaining compliance to TENS.
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient
Compliance is evaluated on a 6 month period prior to the inclusion. Compliant patients to TENS are defined as having 0, 1 or 2 to score of Morisky Medication Adherence Scale. Factors which can explain the lack of compliance will be collected and categorized within "pain centre", "clinician", "TENS characteristics", "patient socio-demographics", "aetiology and characteristics of pain", "efficacy and tolerance" data.
14 secondary outcomes
Efficacy parameters: follow up visits
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: T1month, T3month, T6month
Efficacy parameters: observance
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: T1month, T3month, T6month
Efficacy parameters: pain intensity
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: Pain intensity differences
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: Sum of Pain intensity differences
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: punctual relief
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: Total relief
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: TENS initiation, T1month, T3month, T6month and on a 8-day period preceding the last use of TENS
Efficacy parameters: Quality of life
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
Efficacy parameters: Impression of change
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
Efficacy parameters: Satisfaction
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient at the following timepoints: on the day of the last use of TENS
Efficacy parameters: wish for continuation
Time frame: Data are collected the day of the inclusion.
Mode of use of the TENS
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
Tolerance parameters: AEs
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
Tolerance parameters: premature discontinuation
Time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- 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.
Muriel PERRIOT MOREY principal investigator
Chateauroux hospital - Pain managment center
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Sublimed.
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 14 inclusion and 0 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 (0)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?
Determination of predictive factors explaining compliance to TENS. (time frame: Data are collected the day of the inclusion retrospectively on a 6 month period prior to the inclusion of each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.