PainIMESCUTNCT02988830
Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago
A study testing Subcutaneous Electric Lumbar Stimulation in people with Pain, run by Hopital Foch at 1 site in France.
Trial summary
The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Subcutaneous Electric Lumbar Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2016to 27 Jan 2022
- Phase
- Interventional
- 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
Who may be able to join
- patients over 18 years old
- Having given their non-opposition
- Affiliated to a national insurance scheme or beneficiary
- Suffering for more than a year from a chronic, invalidating lumbago that is refractory in several lines of treatments
Who cannot join
- patients with lumbago that can be surgically handled or which justified a medullary stimulation
- having been operated for the rachis for less than 6 months;
- which cannot for cognitive or cultural reasons contribute to the planned evaluations and to the management of the material (remote control);
- for who the investigator can plan that they cannot be followed during one year from the date of the setting-up (non-observance, planned moving, etc.);
- which present psychological, local or general contraindications to the setting-up of a neurostimulation device (Impossibility to stop anticoagulants or aggregation inhibitors, disturb of the hemostasis, cutaneous infection change on the site of setting-up)
- MRI planned within the next year
- pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.
- Conditions
- Pain
- Being tested
- Subcutaneous Electric Lumbar Stimulation
- Keywords
- Subcutaneous stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous Electric Lumbar StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Chronic lumbar pain | Experimental | Not described Receives: Device: Subcutaneous Electric Lumbar Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain per day on visual analogical scale
Measured: 12 months
Secondary outcomes (10)
Douleur neuropathique 4 (DN4) score
DN4 is a French neuropathic pain scale
Measured: 12 months
Average pain per day on visual analogical scale
Measured: 15 days
OSWESTRY DISABILITY INDEX
Measured: 12 months
36-Item Short Form Health Survey score (SF 36)
Measured: 12 months
DALLAS self-questionnaire
Measured: 12 months
Tampa scale
Measured: 12 months
Questionnaire Hospital Anxiety and Depression scale (HAD)
Measured: 12 months
Pain Catastrophizing Scale (PCS)
Measured: 12 months
Coping strategies questionnaire (CSQ)
Measured: 12 months
Fear Avoidance Belief Questionnaire (FABQ)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start29 Nov 2016
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Christine DJIAN, MD, Principal investigator, Hôpital FochBechir Jarraya, MD, PhD, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988830
- Sponsor's protocol ID
- 2016/39
- Other IDs
- 2016-A00991-50
- Acronym
- IMESCUT
- Status last verified
- Apr 2022
- First submitted
- 30 Nov 2016
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago
- ClinicalTrials.gov ID
- NCT02988830
- Acronym / sponsor ID
- IMESCUT / 2016/39
- Conditions
- Pain
- Keywords
- Subcutaneous stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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.
The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic lumbar pain | Experimental | Device: Subcutaneous Electric Lumbar Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients over 18 years old
- Having given their non-opposition
- Affiliated to a national insurance scheme or beneficiary
- Suffering for more than a year from a chronic, invalidating lumbago that is refractory in several lines of treatments
Key exclusion criteria (7 listed)
- patients with lumbago that can be surgically handled or which justified a medullary stimulation
- having been operated for the rachis for less than 6 months;
- which cannot for cognitive or cultural reasons contribute to the planned evaluations and to the management of the material (remote control);
- for who the investigator can plan that they cannot be followed during one year from the date of the setting-up (non-observance, planned moving, etc.);
- which present psychological, local or general contraindications to the setting-up of a neurostimulation device (Impossibility to stop anticoagulants or aggregation inhibitors, disturb of the hemostasis, cutaneous infection change on the site of setting-up)
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 |
|---|---|---|
| Subcutaneous Electric Lumbar Stimulation | Device | Chronic lumbar pain |
Primary outcome
Average pain per day on visual analogical scale
Time frame: 12 months
10 secondary outcomes
Douleur neuropathique 4 (DN4) score
Time frame: 12 months
Average pain per day on visual analogical scale
Time frame: 15 days
OSWESTRY DISABILITY INDEX
Time frame: 12 months
36-Item Short Form Health Survey score (SF 36)
Time frame: 12 months
DALLAS self-questionnaire
Time frame: 12 months
Tampa scale
Time frame: 12 months
Questionnaire Hospital Anxiety and Depression scale (HAD)
Time frame: 12 months
Pain Catastrophizing Scale (PCS)
Time frame: 12 months
Coping strategies questionnaire (CSQ)
Time frame: 12 months
Fear Avoidance Belief Questionnaire (FABQ)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Marie Christine DJIAN, MD principal investigator
Hôpital Foch
Bechir Jarraya, MD, PhD study chair
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Electric Lumbar Stimulation in people with Pain, run by Hopital Foch at 1 site in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain per day on visual analogical scale (time frame: 12 months). 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 11 Apr 2022.