Chronic Low Back Pain (CLBP)MuscleSCSNCT07215104
A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
A study testing MuscleSCS in people with Chronic Low Back Pain (CLBP), run by WVU Medicine Thomas Hospitals at 1 site in United States.
Trial summary
This study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- MuscleSCS
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 with PSPS type 1 and 2
- Patients with predominant back pain
- Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure
- Age ≥18 y
- Patients with SCS(BurstDR) stimulation in situ for more than 6 month and >50% pain relief. Patients have to be satisfied with their existing SCS therapy and predominantly use a BurstDR stimulation program.
- (Only responders to that therapy should be included, not patients who have not responded to their therapy so far.) [GROUP 1]
- Low back pain baseline score of ≥6 on NRS before spinal cord stimulation therapy and a MCID (Minimal clinically important difference) of >50% with SCS(BurstDRTM) trial stimulation. [GROUP 2]
- Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan
Who cannot join
- Pathology seen on imaging tests obtained within the past 12 month that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery
- Primary symptom of leg pain, or leg pain is greater than back pain
- Back pain is due to any of the following: vascular causes (eg, aortic aneurysm), spinal infection (eg, osteomyelitis), inflammation or damage to the spinal cord (eg, arachnoiditis or syringomyelia), tumor or spinal metastases
- Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain)
- Patient has used a morphine equivalent daily dose of >50 MME in the last 30 days
- Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
Show all 19Show fewer
- Imaging (MRI, CT, x-ray) findings within the last 12 mon that contraindicate lead placement
- Known allergic reaction to implanted materials
- Severe scoliotic deformity (>11◦ in thoracic or lumbar spine)
- Patient has a history of or existing intrathecal drug pump
- Patient with other existing implantable electrical devices, i.e. pacemakers, bladder stimulators, etc.
- Patient has previous experience with neuromodulation devices, including a failed trial
- BMI >40
- Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
- Failed psychologic evaluation
- Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior
- Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center
Charleston, West Virginia, 25301
Amy Young, RN, BSN, DMPNA, 304-347-6144, amelia.young3@wvumedicine.org
About this study
This study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- MuscleSCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MuscleSCSDevice
The population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (>50% pain relief).
Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG.
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Numerical Rating Scale for Pain
Measured: Enrollment to End of Study (3mo Visit)
ODI
Oswestry Disability Index
Measured: Enrollment to End of Study (3mo Visit)
EQ5D-5L
5 Dimension Health Related Quality of Life Questionnaire
Measured: Enrollment to End of Study (3mo Visit)
PDI
Pain Disability Index
Measured: Enrollment to End of Study (3mo Visit)
PCS
Pain Catastrophizing Scale
Measured: Enrollment to End of Study (3mo Visit)
PGIC
Patient Global Impression of Change
Measured: Enrollment to End of Study (3mo Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start7 Oct 2025
- Primary completion7 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)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
- Not applicable
- Intervention model
- Single group
- Model description
- The population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (\>50% pain relief). Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WVU Medicine Thomas Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Timothy R Deer, MD, Principal investigator, WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215104
- Sponsor's protocol ID
- MuscleSCS Study V2.0
- Acronym
- MuscleSCS
- Status last verified
- Oct 2025
- First submitted
- 8 Oct 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07215104
- Acronym / sponsor ID
- MuscleSCS / MuscleSCS Study V2.0
- Conditions
- Chronic Low Back Pain (CLBP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- WVU Medicine Thomas HospitalsUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 7 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Oct 2025 (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 study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- The population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (>50% pain relief). Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with PSPS type 1 and 2
- Patients with predominant back pain
- Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure
- Age ≥18 y
- Patients with SCS(BurstDR) stimulation in situ for more than 6 month and >50% pain relief. Patients have to be satisfied with their existing SCS therapy and predominantly use a BurstDR stimulation program.
Key exclusion criteria (19 listed)
- Pathology seen on imaging tests obtained within the past 12 month that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery
- Primary symptom of leg pain, or leg pain is greater than back pain
- Back pain is due to any of the following: vascular causes (eg, aortic aneurysm), spinal infection (eg, osteomyelitis), inflammation or damage to the spinal cord (eg, arachnoiditis or syringomyelia), tumor or spinal metastases
- Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain)
- Patient has used a morphine equivalent daily dose of >50 MME in the last 30 days
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 |
|---|---|---|
| MuscleSCSThe population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (>50% pain relief). Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG. | Device | – |
Primary outcome
NRS
Time frame: Enrollment to End of Study (3mo Visit)
Numerical Rating Scale for Pain
ODI
Time frame: Enrollment to End of Study (3mo Visit)
Oswestry Disability Index
EQ5D-5L
Time frame: Enrollment to End of Study (3mo Visit)
5 Dimension Health Related Quality of Life Questionnaire
PDI
Time frame: Enrollment to End of Study (3mo Visit)
Pain Disability Index
PCS
Time frame: Enrollment to End of Study (3mo Visit)
Pain Catastrophizing Scale
PGIC
Time frame: Enrollment to End of Study (3mo Visit)
Patient Global Impression of Change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- 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.
Timothy R Deer, MD principal investigator
WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MuscleSCS in people with Chronic Low Back Pain (CLBP), run by WVU Medicine Thomas Hospitals 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 8 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 10 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Young, RN, BSN, DMPNA (304-347-6144, amelia.young3@wvumedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Enrollment to End of Study (3mo Visit)). The study lists 6 primary outcomes in all. 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 10 Oct 2025.