Lowback and Leg PainPhase 4NCT01400282
Analgesic Efficacy of High Frequency Spinal Cord Stimulation
A Phase 4 study testing High frequency spinal cord stimulation in people with Lowback and Leg Pain, run by Ensemble Hospitalier de la Côte at 2 sites in 2 countries.
Trial summary
The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lowback and Leg Pain
- What is being tested?
- High frequency spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2011to Sep 2012
- Phase
- Phase 4
- 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
- Adult, Older adult
Who may be able to join
- signed informed consent
- treated with spinal cord stimulation
- stable pain relief achieved
Who cannot join
- failure to give informed consent
- unable to use or understand how to handle the equipment, PGIC,VAS score or EQ-5D questionnaires.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site, 1 recruiting
- Recruiting
Department of anesthesiology and Pain management, Ensemble Hospitalier de la Côte (EHC)
Morges, 1110
Christophe Perruchoud, MD, +41218042868, christophe.perruchoud@chuv.ch
Christophe Perruchoud, MD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Department of Anaesthesia, The James Cook University Hospital
Middlesbrough
Sam Eldabe, MD, +44 164 228 24 17, Sam.Eldabe@stees.nhs.uk
Sam Eldabe, MD
About this study
Official title: Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study
The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.
- Conditions
- Lowback and Leg Pain
- Being tested
- High frequency spinal cord stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency spinal cord stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | Conventional stimulation (2 weeks)- High frequeny stimulation (2 weeks)- Conventional stimulation (2 weeks)and sham stimulation (2 weeks) Receives: Device: High frequency spinal cord stimulation |
| Sequence 2 | Other | Conventional stimulation (2 weeks)- sham stimulation (2weeks) - Conventional stimulation (2 weeks) - high frequeny stimulation (2 weeks) Receives: Device: High frequency spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Global Impression of Change (PGIC)
Secondary outcomes (2)
Intensity of Pain
Quality of Life (EQ-5D)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lowback and Leg 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ensemble Hospitalier de la Côte
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400282
- Sponsor's protocol ID
- EHC-JCH
- Status last verified
- Jun 2011
- First submitted
- 21 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01400282
- Acronym / sponsor ID
- EHC-JCH
- Conditions
- Lowback and Leg Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ensemble Hospitalier de la CôteUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 22 Jul 2011 (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 compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Device: High frequency spinal cord stimulationConventional stimulation (2 weeks)- High frequeny stimulation (2 weeks)- Conventional stimulation (2 weeks)and sham stimulation (2 weeks) |
| Sequence 2 | Other | Device: High frequency spinal cord stimulationConventional stimulation (2 weeks)- sham stimulation (2weeks) - Conventional stimulation (2 weeks) - high frequeny stimulation (2 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed informed consent
- treated with spinal cord stimulation
- stable pain relief achieved
Key exclusion criteria (2 listed)
- failure to give informed consent
- unable to use or understand how to handle the equipment, PGIC,VAS score or EQ-5D questionnaires.
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 |
|---|---|---|
| High frequency spinal cord stimulation | Device | Sequence 1, Sequence 2 |
Primary outcome
Patient's Global Impression of Change (PGIC)
2 secondary outcomes
Intensity of Pain
Quality of Life (EQ-5D)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High frequency spinal cord stimulation in people with Lowback and Leg Pain, run by Ensemble Hospitalier de la Côte at 2 sites in 2 countries.
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 3 inclusion and 2 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 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christophe Perruchoud, MD (+41218042868, christophe.perruchoud@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's Global Impression of Change (PGIC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400282, which also lists 1 linked publication.
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 22 Jul 2011.