Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)SMASHINGNCT02349659
A Multi-Centre RCT of the Axium® Neurostimulator for the Treatment of Chronic Inguinal Pain Following Surgery
A study testing Implantation with the commercially available Axium neurostimulator in people with Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy), run by Maxima Medical Center at 1 site in Netherlands.
Trial summary
24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM. Subject population is chronic inguinal pain refractory to previous surgical intervention (neurectomy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)
- What is being tested?
- Implantation with the commercially available Axium neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Oct 2017
- 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
- Subject is at least 18 years old
- Subject is able and willing to comply with the follow-up schedule and protocol
- Chronic inguinal pain following Pfannenstiel Incision or Open Inguinal Hernia Repair for at least 6 months
- Previously undergone neurectomy procedure as a treatment for chronic inguinal pain
- Minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS
- Subject is able to provide written informed consent
- Meets of the inclusion criteria for the implantation of a neurostimulation system as set out by the Dutch Neuromodulation Society
- Subject has been screened by a multi-disciplinary panel including the designated psychologist of the Máxima Medical Center and deemed suitable for implantation
Who cannot join
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the Trial
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months
- Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
- Subject is unable to operate the device
- Subjects currently has an active infection
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- Subject has participated in another clinical investigation within 30 days
- Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
- Subject has a current or on going condition, which will probably require MRI investigation sometime in the following 2 years
- Subject has had a spinal surgical procedure at or between vertebral levels T10-L2
- Subject has been diagnosed with cancer in the past 2 years, except for skin malignancies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial to Evaluate the Efficacy of the Spinal Modulation Axium® NeuroStimulator THerapy as a Treatment for Persistent INGuinal Pain Following Surgical Intervention: SMASHING
24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM. Subject population is chronic inguinal pain refractory to previous surgical intervention (neurectomy).
- Being tested
- Implantation with the commercially available Axium neurostimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation with the commercially available Axium neurostimulatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Conservative Medical Management | No intervention | Continued medical management restricted to exclude interventional pain treatments |
| Axium Group | Active comparator | As the CMM group but also treated with Dorsal Root Ganglion stimulation using the Axium neurostimulator Receives: Device: Implantation with the commercially available Axium neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects experiencing ≥50% reduction in average daily pain intensity in the Axium Group as compared to the CMM only group using an eleven point (0-10) numerical pain rating scale (NPRS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: Sponsor withdrawn due to low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)Studies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederique Mol, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349659
- Sponsor's protocol ID
- 24-SMI-2014
- Acronym
- SMASHING
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mol F, Scheltinga M, Roumen R, Wille F, Gultuna I, Kallewaard JW, Elzinga L, van de Minkelis J, Nijhuis H, Stronks DL, Huygen FJPM. Comparing the Efficacy of Dorsal Root Ganglion Stimulation With Conventional Medical Management in Patients With Chronic Postsurgical Inguinal Pain: Post Hoc Analyzed Results of the SMASHING Study. Neuromodulation. 2023 Dec;26(8):1788-1794. doi: 10.1016/j.neurom.2022.09.014. Epub 2022 Nov 29.
PubMed 36456417Mol FMU, Roumen RM, Scheltinga MR. Comparing the efficacy of targeted spinal cord stimulation (SCS) of the dorsal root ganglion with conventional medical management (CMM) in patients with chronic post-surgical inguinal pain: the SMASHING trial. BMC Surg. 2018 Mar 27;18(1):18. doi: 10.1186/s12893-018-0349-8.
PubMed 29587729
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Evaluate the Efficacy of the Spinal Modulation Axium® NeuroStimulator THerapy as a Treatment for Persistent INGuinal Pain Following Surgical Intervention: SMASHING
- ClinicalTrials.gov ID
- NCT02349659
- Acronym / sponsor ID
- SMASHING / 24-SMI-2014
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrawn due to low inclusion rate
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 29 Jan 2015 (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.
24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM. Subject population is chronic inguinal pain refractory to previous surgical intervention (neurectomy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Medical Management | No intervention | –Continued medical management restricted to exclude interventional pain treatments |
| Axium Group | Active comparator | Device: Implantation with the commercially available Axium neurostimulatorAs the CMM group but also treated with Dorsal Root Ganglion stimulation using the Axium neurostimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is at least 18 years old
- Subject is able and willing to comply with the follow-up schedule and protocol
- Chronic inguinal pain following Pfannenstiel Incision or Open Inguinal Hernia Repair for at least 6 months
- Previously undergone neurectomy procedure as a treatment for chronic inguinal pain
- Minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS
Key exclusion criteria (11 listed)
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the Trial
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months
- Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
- Subject is unable to operate the device
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 |
|---|---|---|
| Implantation with the commercially available Axium neurostimulator | Device | Axium Group |
Primary outcome
Percentage of subjects experiencing ≥50% reduction in average daily pain intensity in the Axium Group as compared to the CMM only group using an eleven point (0-10) numerical pain rating scale (NPRS)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Sponsor withdrawn due to low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Derived from this study: PubMed 36456417Mol F, Scheltinga M, Roumen R, Wille F, Gultuna I, Kallewaard JW, Elzinga L, van de Minkelis J, Nijhuis H, Stronks DL, Huygen FJPM. Comparing the Efficacy of Dorsal Root Ganglion Stimulation With Conventional Medical Management in Patients With Chronic Postsurgical Inguinal Pain: Post Hoc Analyzed Results of the SMASHING Study. Neuromodulation. 2023 Dec;26(8):1788-1794. doi: 10.1016/j.neurom.2022.09.014. Epub 2022 Nov 29.
- Derived from this study: PubMed 29587729Mol FMU, Roumen RM, Scheltinga MR. Comparing the efficacy of targeted spinal cord stimulation (SCS) of the dorsal root ganglion with conventional medical management (CMM) in patients with chronic post-surgical inguinal pain: the SMASHING trial. BMC Surg. 2018 Mar 27;18(1):18. doi: 10.1186/s12893-018-0349-8.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation with the commercially available Axium neurostimulator in people with Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy), run by Maxima Medical Center at 1 site in Netherlands.
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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 1 Feb 2017. 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 Netherlands. 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 was stopped early (reason given: Sponsor withdrawn due to low inclusion rate). Results are not available in the source record.
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?
Percentage of subjects experiencing ≥50% reduction in average daily pain intensity in the Axium Group as compared to the CMM only group using an eleven point (0-10) numerical pain rating scale (NPRS) (time frame: 6 months). 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 NCT02349659, which also lists 2 linked publications.
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 1 Feb 2017.