Thoracolumbar Compression FracturesNCT07079865
Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture
An observational study of Thoracolumbar Compression Fractures, run by Saint Peters University Hospital at 4 sites in United States.
Trial summary
The purpose of this study is to track and investigate the outcomes of female patients with acute thoracolumbar compression fractures, focusing on pain management and functional improvement. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Thoracolumbar Compression Fractures
- What is being tested?
- SPRINT PNS modulation system
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Aug 2025to Dec 2026
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient Orthopedic Clinic
Who may be able to join
- Adult females ages 18+
- Osteoporosis diagnosis with acute/subacute insufficiency fractures of the thoracic or lumbar spine identified on MRI or X-ray with significant pain and activity limitation.
- Onset of pain from associated fracture should be less than 3 months.
- Minimum pain should be 4 or greater (Moderate) on the NRS scale and/or impairing their daily activity.
- Patients reported pain should be despite OTC medication trials of NSAIDs, Tylenol, lidocaine patches or similar medications.
- Patients may be taking opioids while receiving treatment however as per routine practice, no additional opioids will be prescribed during the PNS intervention.
Who cannot join
- Patients with pathological fractures, other etiologies of fracture such as pagets disease, multiple myeloma, local or systemic infection, untreated coagulopathy, untreated psychosocial disease.
- Other etiologies of osteoporosis other than primary osteoporosis will be excluded such as hyperparathyroidism, anorexia, malabsorption, hyperthyroidism, or overtreatment of hypothyroidism, chronic renal failure, cushing.
- Patients with diminished mental capacity (mental condition that will inhibit their ability to complete the assessments) as determined by the investigator.
- Patients with an active cardiac implant device such as a pacemaker or defibrillator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University Orthopaedic Associates - Division of OrthoNJ
Avenel, New Jersey, 07001
Dr. Tony George Principal Investigator, 732-283-2663, drgeorge@uognj.com
- Recruiting
University Orthopaedic Associates - Division of OrthoNJ
Morganville, New Jersey, 07751
Dr. Tony George Principal Investigator, 732-283-2663, drgeorge@uognj.com
- Recruiting
University Center for Ambulatory Surgery (UCAS)
Somerset, New Jersey, 08873
Dr. Tony George Principal Investigator, 732-283-2663, drgeorge@uognj.com
- Recruiting
University Orthopaedic Associates - Division of OrthoNJ
Somerset, New Jersey, 08873
Dr. Tony George Principal Investigator, 732-283-2663, drgeorge@uognj.com
About this study
The purpose of this study is to track and investigate the outcomes of female patients with acute thoracolumbar compression fractures, focusing on pain management and functional improvement. The study will investigate patients whose compression fractures are within 3 months or less and measure pain scores, using the Numeric Rating Scale (NRS) and Brief Pain Inventory (BPI) and quality of life using the PROMIS questionnaire at 1-week prior to intervention and then 2 weeks, 3 months and 6 months post PNS implantation.
The primary aim is to assess pain reduction among participants that receive the 60-day PNS intervention. The secondary aim is to analyze functional outcomes and quality of life documented in PROMs (Patient Reported Outcomes Measures) provided by CareSense a digital data collection system.
- Conditions
- Thoracolumbar Compression Fractures
- Being tested
- SPRINT PNS modulation system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPRINT PNS modulation systemDevice
Participants will receive treatment using the commercially available SPRINT PNS system. Their pain levels will be assessed using qualified scales including NRS and BPI and their quality of life using the PROMIS scale.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Pain as measured using a numeric rating scale (NRS). A 0 - 10 point scale with 0 representing no pain, 1-3 mild, 4-6 moderate and 7-10 severe.
Measured: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Change in Pain
Pain as measured using a Brief Pain Inventory (BPI). A 0 - 10 point scale with 0 representing no pain and 10 representing severe pain.
Measured: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Secondary outcomes (1)
Change in Quality of Life (QOL)
QOL as measured by PROMIS (Patient-Reported Outcomes Measurement Information System). Responses are scored on 20 to 80 point scale. Scores between 20-55 are within normal limits. Scores 55+ will fall within mild-moderate-severe.
Measured: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start7 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Thoracolumbar Compression FracturesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Peters University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Orthopaedic Associates - Division of OrthoNJ
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079865
- Sponsor's protocol ID
- IRB-FY2024-41
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int. 2005 Mar;16 Suppl 2:S3-7. doi: 10.1007/s00198-004-1702-6. Epub 2004 Sep 8.
PubMed 15365697Gautam S, Gopal VG, Khuba S, Agarwal A, V M, Kumar S. Evaluation of the role of vertebral augmentation in chronic vertebral compression fractures: A retrospective study. Interv Pain Med. 2023 Mar 11;2(1):100242. doi: 10.1016/j.inpm.2023.100242. eCollection 2023 Mar.
PubMed 39239614Chitneni A, Berger AA, Orhurhu V, Kaye AD, Hasoon J. Peripheral Nerve Stimulation of the Saphenous and Superior Lateral Genicular Nerves for Chronic Pain After Knee Surgery. Orthop Rev (Pavia). 2021 May 31;13(2):24435. doi: 10.52965/001c.24435. eCollection 2021.
PubMed 34745463Huntoon MA, Slavin KV, Hagedorn JM, Crosby ND, Boggs JW. A Retrospective Review of Real-world Outcomes Following 60-day Peripheral Nerve Stimulation for the Treatment of Chronic Pain. Pain Physician. 2023 May;26(3):273-281.
PubMed 37192232Gabriel RA, Ilfeld BM. Acute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system. Expert Rev Med Devices. 2021 Feb;18(2):145-150. doi: 10.1080/17434440.2021.1877134. Epub 2021 Jan 20.
PubMed 33446005Buchbinder R, Johnston RV, Rischin KJ, Homik J, Jones CA, Golmohammadi K, Kallmes DF. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. 2018 Apr 4;4(4):CD006349. doi: 10.1002/14651858.CD006349.pub3.
PubMed 29618171Bernhard J, Heini PF, Villiger PM. Asymptomatic diffuse pulmonary embolism caused by acrylic cement: an unusual complication of percutaneous vertebroplasty. Ann Rheum Dis. 2003 Jan;62(1):85-6. doi: 10.1136/ard.62.1.85. No abstract available.
PubMed 12480681Prince RL, Lewis JR, Lim WH, Wong G, Wilson KE, Khoo BC, Zhu K, Kiel DP, Schousboe JT. Adding Lateral Spine Imaging for Vertebral Fractures to Densitometric Screening: Improving Ascertainment of Patients at High Risk of Incident Osteoporotic Fractures. J Bone Miner Res. 2019 Feb;34(2):282-289. doi: 10.1002/jbmr.3595. Epub 2018 Nov 5.
PubMed 30395687Wright NC, Looker AC, Saag KG, Curtis JR, Delzell ES, Randall S, Dawson-Hughes B. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res. 2014 Nov;29(11):2520-6. doi: 10.1002/jbmr.2269.
PubMed 24771492
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 60-day Peripheral Nerve Stimulation (PNS) in Alleviating Pain and Improving Function After Acute Thoracolumbar Compression Fracture
- ClinicalTrials.gov ID
- NCT07079865
- Acronym / sponsor ID
- IRB-FY2024-41
- Conditions
- Thoracolumbar Compression Fractures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Saint Peters University HospitalUniversity, hospital or other
- Collaborators
- University Orthopaedic Associates - Division of OrthoNJ
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jul 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.
The purpose of this study is to track and investigate the outcomes of female patients with acute thoracolumbar compression fractures, focusing on pain management and functional improvement. The study will investigate patients whose compression fractures are within 3 months or less and measure pain scores, using the Numeric Rating Scale (NRS) and Brief Pain Inventory (BPI) and quality of life using the PROMIS questionnaire at 1-week prior to intervention and then 2 weeks, 3 months and 6 months post PNS implantation.
The primary aim is to assess pain reduction among participants that receive the 60-day PNS intervention. The secondary aim is to analyze functional outcomes and quality of life documented in PROMs (Patient Reported Outcomes Measures) provided by CareSense a digital data collection system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient Orthopedic Clinic
Key inclusion criteria (6 listed)
- Adult females ages 18+
- Osteoporosis diagnosis with acute/subacute insufficiency fractures of the thoracic or lumbar spine identified on MRI or X-ray with significant pain and activity limitation.
- Onset of pain from associated fracture should be less than 3 months.
- Minimum pain should be 4 or greater (Moderate) on the NRS scale and/or impairing their daily activity.
- Patients reported pain should be despite OTC medication trials of NSAIDs, Tylenol, lidocaine patches or similar medications.
Key exclusion criteria (4 listed)
- Patients with pathological fractures, other etiologies of fracture such as pagets disease, multiple myeloma, local or systemic infection, untreated coagulopathy, untreated psychosocial disease.
- Other etiologies of osteoporosis other than primary osteoporosis will be excluded such as hyperparathyroidism, anorexia, malabsorption, hyperthyroidism, or overtreatment of hypothyroidism, chronic renal failure, cushing.
- Patients with diminished mental capacity (mental condition that will inhibit their ability to complete the assessments) as determined by the investigator.
- Patients with an active cardiac implant device such as a pacemaker or defibrillator.
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 |
|---|---|---|
| SPRINT PNS modulation systemParticipants will receive treatment using the commercially available SPRINT PNS system. Their pain levels will be assessed using qualified scales including NRS and BPI and their quality of life using the PROMIS scale. | Device | – |
Primary outcome
Change in Pain
Time frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Pain as measured using a numeric rating scale (NRS). A 0 - 10 point scale with 0 representing no pain, 1-3 mild, 4-6 moderate and 7-10 severe.
Change in Pain
Time frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
Pain as measured using a Brief Pain Inventory (BPI). A 0 - 10 point scale with 0 representing no pain and 10 representing severe pain.
1 secondary outcome
Change in Quality of Life (QOL)
Time frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation
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 18 Feb 2026.
- Background: PubMed 15365697Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int. 2005 Mar;16 Suppl 2:S3-7. doi: 10.1007/s00198-004-1702-6. Epub 2004 Sep 8.
- Background: PubMed 39239614Gautam S, Gopal VG, Khuba S, Agarwal A, V M, Kumar S. Evaluation of the role of vertebral augmentation in chronic vertebral compression fractures: A retrospective study. Interv Pain Med. 2023 Mar 11;2(1):100242. doi: 10.1016/j.inpm.2023.100242. eCollection 2023 Mar.
- Background: PubMed 34745463Chitneni A, Berger AA, Orhurhu V, Kaye AD, Hasoon J. Peripheral Nerve Stimulation of the Saphenous and Superior Lateral Genicular Nerves for Chronic Pain After Knee Surgery. Orthop Rev (Pavia). 2021 May 31;13(2):24435. doi: 10.52965/001c.24435. eCollection 2021.
- Background: PubMed 37192232Huntoon MA, Slavin KV, Hagedorn JM, Crosby ND, Boggs JW. A Retrospective Review of Real-world Outcomes Following 60-day Peripheral Nerve Stimulation for the Treatment of Chronic Pain. Pain Physician. 2023 May;26(3):273-281.
- Background: PubMed 33446005Gabriel RA, Ilfeld BM. Acute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system. Expert Rev Med Devices. 2021 Feb;18(2):145-150. doi: 10.1080/17434440.2021.1877134. Epub 2021 Jan 20.
- Background: PubMed 29618171Buchbinder R, Johnston RV, Rischin KJ, Homik J, Jones CA, Golmohammadi K, Kallmes DF. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. 2018 Apr 4;4(4):CD006349. doi: 10.1002/14651858.CD006349.pub3.
- Background: PubMed 12480681Bernhard J, Heini PF, Villiger PM. Asymptomatic diffuse pulmonary embolism caused by acrylic cement: an unusual complication of percutaneous vertebroplasty. Ann Rheum Dis. 2003 Jan;62(1):85-6. doi: 10.1136/ard.62.1.85. No abstract available.
- Background: PubMed 30395687Prince RL, Lewis JR, Lim WH, Wong G, Wilson KE, Khoo BC, Zhu K, Kiel DP, Schousboe JT. Adding Lateral Spine Imaging for Vertebral Fractures to Densitometric Screening: Improving Ascertainment of Patients at High Risk of Incident Osteoporotic Fractures. J Bone Miner Res. 2019 Feb;34(2):282-289. doi: 10.1002/jbmr.3595. Epub 2018 Nov 5.
- Background: PubMed 24771492Wright NC, Looker AC, Saag KG, Curtis JR, Delzell ES, Randall S, Dawson-Hughes B. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res. 2014 Nov;29(11):2520-6. doi: 10.1002/jbmr.2269.
- Individual participant dataSharing planned: Undecided
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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.
University Orthopaedic Associates - Division of OrthoNJ
Avenel, United States
University Orthopaedic Associates - Division of OrthoNJ
Morganville, United States
University Center for Ambulatory Surgery (UCAS)
Somerset, United States
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracolumbar Compression Fractures, run by Saint Peters University Hospital at 4 sites 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 6 inclusion and 4 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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: Baseline (pre-SPRINT PNS) to 2 Weeks Post, 3 Months Post and 6 Months Post Implantation). The study lists 2 primary outcomes in all. 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 NCT07079865, which also lists 9 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 18 Feb 2026.