Spinal; Nerve Root, PainACTIVENCT03417973
Quality of Life and Pain Changes Due to DRG Stimulation for Chronic Pain
An observational study of Spinal; Nerve Root, Pain and Pelvic Pain, run by KM Clinical Research Group at 1 site in United States.
Trial summary
ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal; Nerve Root, Pain, Pelvic Pain, Regional Pain Syndrome
- What is being tested?
- dorsal root ganglion neuromodulation
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Mar 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients medically indicated to receive DRG stimulator for treatment of chronic lower limb and/or pelvic pain.
Who may be able to join
- Prescribed orthopedic surgery or procedure by their healthcare provider.
- Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief.
- Willing and able to adhere to the protocol of the study including the survey timeline.
- Between the ages of 18-85 years.
Who cannot join
- Inability or unwillingness to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
KM Clinical Research Group
Murrieta, California, 92563
About this study
Official title: A Prospective Single-arm, Multi-center Clinical Study Examining Quality of Life and Pain Following Dorsal Root Ganglion Stimulation for the Treatment of Chronic Intractable Pelvic and Lower Limb Pain
ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.
Read the detailed description
Objectives The primary objective is changes in pelvis and/or lower limb pain following dorsal root ganglion (DRG) stimulation. Pain levels will be determined using a 10-point Visual Analog Scale (VAS) with 10= Extreme Pain and 0= No Pain.
The null hypothesis is there will be no change in the subjects' self-reported pain levels from baseline to 52 weeks post-stimulator implantation. The alternate hypothesis is a significant change in pain levels.
Secondary objectives include changes in physical health, quality of life, and pain-related prescription medication usage. Each subject's overall quality of life will be measured with the National Institute of Health's PROMIS Global Health survey v1.2. Physical activity changes will be assessed using the NIH PROMIS Pain Interference 6a SF v1.0 and Pain Intensity 3a scale v1.0. Finally, patients will be asked the name, dosage, and frequency of use of any pelvic and/or lower limb pain-related prescription medications they are currently using.
Design and Outcomes This is a prospective observational single-arm study to access the primary outcome variable of pelvic and/or lower limb pain Intervention and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre and post-operative pain, physical activity levels, quality of life, and medication use. Subjects will be followed for 12 months following their DRG stimulation implant surgery.
Sample Size and Population This study will last for 4 years starting July 1, 2017. There will be no maximum subject population size. We aim for a minimum population size of 500 in order to give statistical significance with results. Subjects will be stratified by area of chronic pain.
- Conditions
- Spinal; Nerve Root, Pain, Pelvic Pain, Regional Pain Syndrome, Chronic Pain Syndrome, Complex Regional Pain Syndromes
- Being tested
- dorsal root ganglion neuromodulation
- Keywords
- dorsal root ganglion
- Medical subject headings
- Pain, Pelvic Pain, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dorsal root ganglion neuromodulationDevice
stimulation for neuromodulation of the dorsal root ganglion
| Study group | Role | What they receive |
|---|---|---|
| complex regional pain syndrome | Chronic regional pain of lower limb(s) patients medically indicated to have dorsal root ganglion (DRG) stimulation for control of pain. DRG stimulator will be implanted for trial of 3-4 days and then permanently, if patient find acceptable levels of pain control with trial. Receives: Device: dorsal root ganglion neuromodulation | |
| Chronic pelvic pain | Chronic pelvic or urological pain patients medically indicated to have dorsal root ganglion (DRG) stimulation for control of pain. DRG stimulator will be implanted for trial of 3-4 days and then permanently, if patient find acceptable levels of pain control with trial. Receives: Device: dorsal root ganglion neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
change in visual analogue scale rating
Measured: 12 months post-permanent dorsal root ganglion stimulator implantation
Secondary outcomes (2)
Change in quality of life
change in NIH PROMIS Global health v2 score
Measured: 12 months post-permanent dorsal root ganglion stimulator implantation
Change in physical health
Change in Pain Behavior and Pain Interference measures
Measured: 12 months post-permanent dorsal root ganglion stimulator implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Aug 2017
- Primary completion28 Feb 2019
- Study completion31 Mar 2019
Why it stopped: Sponsor withdrew funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal; Nerve Root, 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
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- KM Clinical Research Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Kate McLellan, KM Clinical Research Group
- Investigators
- Kate McLellan, PhD, Principal investigator, KM Clinical Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417973
- Sponsor's protocol ID
- 2017-PN-01
- Acronym
- ACTIVE
- Status last verified
- Mar 2020
- First submitted
- 11 Aug 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Other researchers will only see participation data for the subjects they recruit and enroll in the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm, Multi-center Clinical Study Examining Quality of Life and Pain Following Dorsal Root Ganglion Stimulation for the Treatment of Chronic Intractable Pelvic and Lower Limb Pain
- ClinicalTrials.gov ID
- NCT03417973
- Acronym / sponsor ID
- ACTIVE / 2017-PN-01
- Conditions
- Spinal; Nerve Root, Pain, Pelvic Pain, Regional Pain Syndrome, Chronic Pain Syndrome, Complex Regional Pain Syndromes
- Keywords
- dorsal root ganglion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew funding
- Enrolment
- 55 participants (actual)
- Lead sponsor
- KM Clinical Research GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 31 Jan 2018 (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.
ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.
Detailed description
Objectives The primary objective is changes in pelvis and/or lower limb pain following dorsal root ganglion (DRG) stimulation. Pain levels will be determined using a 10-point Visual Analog Scale (VAS) with 10= Extreme Pain and 0= No Pain.
The null hypothesis is there will be no change in the subjects' self-reported pain levels from baseline to 52 weeks post-stimulator implantation. The alternate hypothesis is a significant change in pain levels.
Secondary objectives include changes in physical health, quality of life, and pain-related prescription medication usage. Each subject's overall quality of life will be measured with the National Institute of Health's PROMIS Global Health survey v1.2. Physical activity changes will be assessed using the NIH PROMIS Pain Interference 6a SF v1.0 and Pain Intensity 3a scale v1.0. Finally, patients will be asked the name, dosage, and frequency of use of any pelvic and/or lower limb pain-related prescription medications they are currently using.
Design and Outcomes This is a prospective observational single-arm study to access the primary outcome variable of pelvic and/or lower limb pain Intervention and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre and post-operative pain, physical activity levels, quality of life, and medication use. Subjects will be followed for 12 months following their DRG stimulation implant surgery.
Sample Size and Population This study will last for 4 years starting July 1, 2017. There will be no maximum subject population size. We aim for a minimum population size of 500 in order to give statistical significance with results. Subjects will be stratified by area of chronic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complex regional pain syndrome | – | Device: dorsal root ganglion neuromodulationChronic regional pain of lower limb(s) patients medically indicated to have dorsal root ganglion (DRG) stimulation for control of pain. DRG stimulator will be implanted for trial of 3-4 days and then permanently, if patient find acceptable levels of pain control with trial. |
| Chronic pelvic pain | – | Device: dorsal root ganglion neuromodulationChronic pelvic or urological pain patients medically indicated to have dorsal root ganglion (DRG) stimulation for control of pain. DRG stimulator will be implanted for trial of 3-4 days and then permanently, if patient find acceptable levels of pain control with trial. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients medically indicated to receive DRG stimulator for treatment of chronic lower limb and/or pelvic pain.
Key inclusion criteria (4 listed)
- Prescribed orthopedic surgery or procedure by their healthcare provider.
- Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief.
- Willing and able to adhere to the protocol of the study including the survey timeline.
- Between the ages of 18-85 years.
Key exclusion criteria (1 listed)
- Inability or unwillingness to give written informed consent.
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 |
|---|---|---|
| dorsal root ganglion neuromodulationstimulation for neuromodulation of the dorsal root ganglion | Device | Chronic pelvic pain, complex regional pain syndrome |
Primary outcome
Change in pain
Time frame: 12 months post-permanent dorsal root ganglion stimulator implantation
change in visual analogue scale rating
2 secondary outcomes
Change in quality of life
Time frame: 12 months post-permanent dorsal root ganglion stimulator implantation
Change in physical health
Time frame: 12 months post-permanent dorsal root ganglion stimulator implantation
Results and safety
The study was stopped early (reason given: Sponsor withdrew funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No. Other researchers will only see participation data for the subjects they recruit and enroll in the study.
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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.
Kate McLellan, PhD principal investigator
KM Clinical Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal; Nerve Root, Pain and Pelvic Pain, run by KM Clinical Research Group at 1 site in United States.
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 1 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 19 Mar 2020. 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 United States. 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 withdrew funding). 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?
Change in pain (time frame: 12 months post-permanent dorsal root ganglion stimulator implantation). 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 19 Mar 2020.