Shoulder PainNCT05649917
SPR PNS for Chronic Shoulder Pain
An observational study of Shoulder Pain and Shoulder Injuries, run by International Spine, Pain and Performance Center at 2 sites in United States.
Trial summary
The purpose of this research is to gather post-market data regarding the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System for the treatment of chronic shoulder pain due to chronic degenerative changes of your shoulder. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Shoulder Injuries, Shoulder Arthritis
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2022to Jul 2024
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll up to 20 patients with pain due to degenerative changes in the shoulder scheduled for commercial placement of the SPRINT PNS System.
Who may be able to join
- At least 21 years old
- Diagnosed with degenerative changes within the shoulder complex
- Scheduled for a commercial SPRINT PNS procedure
- Shoulder pain score at baseline >5 as demonstrated by PROMIS 29
- Able to understand and willing to take part in study and comply with all study requirements
Who cannot join
- No shoulder pain at rest
- Pain exclusively in the anterior aspect of the shoulder
- Confounding conditions such as cervical radiculopathy, inflammatory arthritis, complete rotator cuff tear, or ipsilateral shoulder surgery in the past one year
- Daily opioid use >90 m morphine equivalent at any point in the past month
- Opioids for any condition other than shoulder pain
- Deep brain stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap with the SPRINT system.
Show all 10Show fewer
- Any other condition that may interfere with the ability to participate in a clinical trial (e.g. anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled DM) as determined by the Investigator
- Vulnerable populations (e.g., prisoners, minors, students, employees)
- Workers Compensation
- Pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
International Spine Pain & Performance Center
Arlington, Virginia, 22205
Mehul Desai, MD, MPH, 202-808-8295, research@isppcenter.com
Selma Paul, 202-808-8295, spaul@isppcenter.com
- Recruiting
International Spine Pain & Performance Center
Washington D.C., District of Columbia, 20006
Mehul Desai, MD, MPH, 202-808-8295, research@isppcenter.com
Selma Paul, BS, 202-808-8295, spaul@isppcenter.com
About this study
Official title: A Post-Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain
The purpose of this research is to gather post-market data regarding the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System for the treatment of chronic shoulder pain due to chronic degenerative changes of your shoulder. The System delivers mild electrical stimulation to the muscles in your shoulder. The System includes up to two leads (small wires) that are placed through your skin into your shoulder. The leads attach to a device worn on your body that deliver stimulation (called a Stimulator). The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain.
Read the detailed description
Background
Chronic degenerative changes in the shoulder are a frequent source of debilitating chronic pain. In particular, osteoarthritis of the shoulder has been estimated to affect up to 32.8% of the adult population over the age of 60, and OA in general is one of the most frequent causes of disability in the United States.1 OA impacts the quality of life of tens of millions of Americans and carries a significant economic burden of over $60 billion in the U.S. each year.2
Degenerative joint disease in the shoulder is commonly managed with physical therapy and over-the-counter medications, but these modalities can be insufficient for pain management as degeneration progresses.3 Corticosteroid injections, radiofrequency ablations, and even partial or total shoulder arthroplasty are used to treat advanced cases3, and these interventions often either have limited long-term effectiveness or are associated with significant invasiveness or other side effects and complications.
Peripheral nerve stimulation (PNS) is a neuromodulatory technique that seeks to provide pain relief through stimulation of the nerves that innervate the shoulder (e.g., the suprascapular nerve and axillary nerve). A novel, 60-day percutaneous PNS system that is FDA-cleared has shown effectiveness for chronic shoulder pain following stroke and shoulder impingement syndrome4-15, and has demonstrated the potential to provide sustained relief following the short-term, 60-day treatment.8, 15-18 The mechanism of action of neuropathic pain in osteoarthritis is proposed to be via peripheral sensitization (e.g., axillary and suprascapular nerves) that leads to subsequent upstream hypersensitization of the central nervous system; the proposed mechanism of long-term pain relief with 60-day PNS via reconditioning of the CNS to reverse hypersensitization therefore suggests that the treatment may be effective for degenerative shoulder including OA.19, 20 However, no study has prospectively evaluated the use of 60-day, percutaneous PNS for the treatment of debilitating pain associated with degenerative changes in the shoulder. The goal of this study is therefore to collect data on the use of 60-day PNS for the treatment of chronic pain associated with degenerative shoulder.
Objectives
The study objective is to gather post-market data regarding the effectiveness of the SPRINT PNS System for the treatment of chronic shoulder pain due to degenerative changes of the shoulder.
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Arthritis
- Keywords
- Peripheral Nerve Stimulation, Shoulder Pain, Shoulder Injuries
- Medical subject headings
- Shoulder Pain, Shoulder Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in average pain and/or reduction in pain interference
Average pain intensity is measured using the PROMIS-29 v2.0 profile. The measure assesses pain intensity using a single 0-10 numeric rating scale. Average pain interference is measured using Brief Pain Inventory--Short Form Question #9 (BPI-9). BPI-9 uses a 0-10 numeric rating scale across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.)
Measured: 3 months
Secondary outcomes (4)
Changes in pain intensity
Changes in pain intensity will be assessed using the PROMIS-29 v2.0 profile. The measure assesses pain intensity using a single 0-10 numeric rating scale.
Measured: 1 year
Changes in pain interference
Changes in average pain interference are measured using Brief Pain Inventory--Short Form Question #9. The measure assesses pain interference using a 0-10 numeric rating scale across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.)
Measured: 1 year
Changes in Shoulder Function
Shoulder function is measured using the Western Ontario Arthritis of the Shoulder (WOOS) index. The WOOS index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis.
Measured: 1 year
Changes in shoulder range of motion
Shoulder range of motion is measured as degrees of active range of motion (flexion, abduction, internal rotation, and external rotation) based on physical examination.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start6 Jul 2022
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Spine, Pain and Performance Center
- Sponsor type
- University, hospital or other
- Collaborators
- SPR Therapeutics, Inc.
- Responsible party
- Principal investigator, Mehul J. Desai, International Spine, Pain and Performance Center
- Investigators
- Mehul Desai, MD, MPH, Principal investigator, International Spine Pain & Performance Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649917
- Sponsor's protocol ID
- 20223406
- Status last verified
- Sep 2023
- First submitted
- 23 Aug 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chillemi C, Franceschini V. Shoulder osteoarthritis. Arthritis. 2013;2013:370231. doi: 10.1155/2013/370231. Epub 2013 Jan 10.
PubMed 23365745Buckwalter JA, Saltzman C, Brown T. The impact of osteoarthritis: implications for research. Clin Orthop Relat Res. 2004 Oct;(427 Suppl):S6-15. doi: 10.1097/01.blo.0000143938.30681.9d.
PubMed 15480076Millett PJ, Gobezie R, Boykin RE. Shoulder osteoarthritis: diagnosis and management. Am Fam Physician. 2008 Sep 1;78(5):605-11.
PubMed 18788237Chae J, Yu D, Walker M. Percutaneous, intramuscular neuromuscular electrical stimulation for the treatment of shoulder subluxation and pain in chronic hemiplegia: a case report. Am J Phys Med Rehabil. 2001 Apr;80(4):296-301. doi: 10.1097/00002060-200104000-00014.
PubMed 11277137Yu DT, Chae J, Walker ME, Fang ZP. Percutaneous intramuscular neuromuscular electric stimulation for the treatment of shoulder subluxation and pain in patients with chronic hemiplegia: a pilot study. Arch Phys Med Rehabil. 2001 Jan;82(1):20-5. doi: 10.1053/apmr.2001.18666.
PubMed 11239281Renzenbrink GJ, IJzerman MJ. Percutaneous neuromuscular electrical stimulation (P-NMES) for treating shoulder pain in chronic hemiplegia. Effects on shoulder pain and quality of life. Clin Rehabil. 2004 Jun;18(4):359-65. doi: 10.1191/0269215504cr759oa.
PubMed 15180118Yu DT, Chae J, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Feldstein M, Fang ZP. Intramuscular neuromuscular electric stimulation for poststroke shoulder pain: a multicenter randomized clinical trial. Arch Phys Med Rehabil. 2004 May;85(5):695-704. doi: 10.1016/j.apmr.2003.07.015.
PubMed 15129391Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP. Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. Am J Phys Med Rehabil. 2005 Nov;84(11):832-42. doi: 10.1097/01.phm.0000184154.01880.72.
PubMed 16244520Chae J, Ng A, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Intramuscular electrical stimulation for shoulder pain in hemiplegia: does time from stroke onset predict treatment success? Neurorehabil Neural Repair. 2007 Nov-Dec;21(6):561-7. doi: 10.1177/1545968306298412. Epub 2007 Mar 16.
PubMed 17369520Wilson RD, Bennett ME, Lechman TE, Stager KW, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Arch Phys Med Rehabil. 2011 May;92(5):837-40. doi: 10.1016/j.apmr.2010.11.003.
PubMed 21530732Wilson RD, Harris MA, Bennett ME, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of shoulder pain from subacromial impingement syndrome. PM R. 2012 Aug;4(8):624-8. doi: 10.1016/j.pmrj.2012.03.002.
PubMed 22920317Chae J, Wilson RD, Bennett ME, Lechman TE, Stager KW. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case series. Pain Pract. 2013 Jan;13(1):59-67. doi: 10.1111/j.1533-2500.2012.00541.x. Epub 2012 Mar 26.
PubMed 22448759Wilson RD, Gunzler DD, Bennett ME, Chae J. Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial. Am J Phys Med Rehabil. 2014 Jan;93(1):17-28. doi: 10.1097/PHM.0000000000000011.
PubMed 24355994Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series. Neuromodulation. 2014 Dec;17(8):771-6; discussion 776. doi: 10.1111/ner.12152. Epub 2014 Feb 11.
PubMed 24512114Wilson RD, Bennett ME, Nguyen VQC, Bock WC, O'Dell MW, Watanabe TK, Amundson RH, Hoyen HA, Chae J. Fully Implantable Peripheral Nerve Stimulation for Hemiplegic Shoulder Pain: A Multi-Site Case Series With Two-Year Follow-Up. Neuromodulation. 2018 Apr;21(3):290-295. doi: 10.1111/ner.12726. Epub 2017 Nov 22.
PubMed 29164745
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT05649917
- Acronym / sponsor ID
- 20223406
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Arthritis
- Keywords
- Peripheral Nerve Stimulation, Shoulder Pain, Shoulder Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- International Spine, Pain and Performance CenterUniversity, hospital or other
- Collaborators
- SPR Therapeutics, Inc.
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 14 Dec 2022 (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 research is to gather post-market data regarding the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System for the treatment of chronic shoulder pain due to chronic degenerative changes of your shoulder. The System delivers mild electrical stimulation to the muscles in your shoulder. The System includes up to two leads (small wires) that are placed through your skin into your shoulder. The leads attach to a device worn on your body that deliver stimulation (called a Stimulator). The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain.
Detailed description
Background
Chronic degenerative changes in the shoulder are a frequent source of debilitating chronic pain. In particular, osteoarthritis of the shoulder has been estimated to affect up to 32.8% of the adult population over the age of 60, and OA in general is one of the most frequent causes of disability in the United States.1 OA impacts the quality of life of tens of millions of Americans and carries a significant economic burden of over $60 billion in the U.S. each year.2
Degenerative joint disease in the shoulder is commonly managed with physical therapy and over-the-counter medications, but these modalities can be insufficient for pain management as degeneration progresses.3 Corticosteroid injections, radiofrequency ablations, and even partial or total shoulder arthroplasty are used to treat advanced cases3, and these interventions often either have limited long-term effectiveness or are associated with significant invasiveness or other side effects and complications.
Peripheral nerve stimulation (PNS) is a neuromodulatory technique that seeks to provide pain relief through stimulation of the nerves that innervate the shoulder (e.g., the suprascapular nerve and axillary nerve). A novel, 60-day percutaneous PNS system that is FDA-cleared has shown effectiveness for chronic shoulder pain following stroke and shoulder impingement syndrome4-15, and has demonstrated the potential to provide sustained relief following the short-term, 60-day treatment.8, 15-18 The mechanism of action of neuropathic pain in osteoarthritis is proposed to be via peripheral sensitization (e.g., axillary and suprascapular nerves) that leads to subsequent upstream hypersensitization of the central nervous system; the proposed mechanism of long-term pain relief with 60-day PNS via reconditioning of the CNS to reverse hypersensitization therefore suggests that the treatment may be effective for degenerative shoulder including OA.19, 20 However, no study has prospectively evaluated the use of 60-day, percutaneous PNS for the treatment of debilitating pain associated with degenerative changes in the shoulder. The goal of this study is therefore to collect data on the use of 60-day PNS for the treatment of chronic pain associated with degenerative shoulder.
Objectives
The study objective is to gather post-market data regarding the effectiveness of the SPRINT PNS System for the treatment of chronic shoulder pain due to degenerative changes of the shoulder.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll up to 20 patients with pain due to degenerative changes in the shoulder scheduled for commercial placement of the SPRINT PNS System.
Key inclusion criteria (5 listed)
- At least 21 years old
- Diagnosed with degenerative changes within the shoulder complex
- Scheduled for a commercial SPRINT PNS procedure
- Shoulder pain score at baseline >5 as demonstrated by PROMIS 29
- Able to understand and willing to take part in study and comply with all study requirements
Key exclusion criteria (10 listed)
- No shoulder pain at rest
- Pain exclusively in the anterior aspect of the shoulder
- Confounding conditions such as cervical radiculopathy, inflammatory arthritis, complete rotator cuff tear, or ipsilateral shoulder surgery in the past one year
- Daily opioid use >90 m morphine equivalent at any point in the past month
- Opioids for any condition other than shoulder pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction in average pain and/or reduction in pain interference
Time frame: 3 months
Average pain intensity is measured using the PROMIS-29 v2.0 profile. The measure assesses pain intensity using a single 0-10 numeric rating scale. Average pain interference is measured using Brief Pain Inventory--Short Form Question #9 (BPI-9). BPI-9 uses a 0-10 numeric rating scale across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.)
4 secondary outcomes
Changes in pain intensity
Time frame: 1 year
Changes in pain interference
Time frame: 1 year
Changes in Shoulder Function
Time frame: 1 year
Changes in shoulder range of motion
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 23365745Chillemi C, Franceschini V. Shoulder osteoarthritis. Arthritis. 2013;2013:370231. doi: 10.1155/2013/370231. Epub 2013 Jan 10.
- Background: PubMed 15480076Buckwalter JA, Saltzman C, Brown T. The impact of osteoarthritis: implications for research. Clin Orthop Relat Res. 2004 Oct;(427 Suppl):S6-15. doi: 10.1097/01.blo.0000143938.30681.9d.
- Background: PubMed 18788237Millett PJ, Gobezie R, Boykin RE. Shoulder osteoarthritis: diagnosis and management. Am Fam Physician. 2008 Sep 1;78(5):605-11.
- Background: PubMed 11277137Chae J, Yu D, Walker M. Percutaneous, intramuscular neuromuscular electrical stimulation for the treatment of shoulder subluxation and pain in chronic hemiplegia: a case report. Am J Phys Med Rehabil. 2001 Apr;80(4):296-301. doi: 10.1097/00002060-200104000-00014.
- Background: PubMed 11239281Yu DT, Chae J, Walker ME, Fang ZP. Percutaneous intramuscular neuromuscular electric stimulation for the treatment of shoulder subluxation and pain in patients with chronic hemiplegia: a pilot study. Arch Phys Med Rehabil. 2001 Jan;82(1):20-5. doi: 10.1053/apmr.2001.18666.
- Background: PubMed 15180118Renzenbrink GJ, IJzerman MJ. Percutaneous neuromuscular electrical stimulation (P-NMES) for treating shoulder pain in chronic hemiplegia. Effects on shoulder pain and quality of life. Clin Rehabil. 2004 Jun;18(4):359-65. doi: 10.1191/0269215504cr759oa.
- Background: PubMed 15129391Yu DT, Chae J, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Feldstein M, Fang ZP. Intramuscular neuromuscular electric stimulation for poststroke shoulder pain: a multicenter randomized clinical trial. Arch Phys Med Rehabil. 2004 May;85(5):695-704. doi: 10.1016/j.apmr.2003.07.015.
- Background: PubMed 16244520Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP. Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. Am J Phys Med Rehabil. 2005 Nov;84(11):832-42. doi: 10.1097/01.phm.0000184154.01880.72.
- Background: PubMed 17369520Chae J, Ng A, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Intramuscular electrical stimulation for shoulder pain in hemiplegia: does time from stroke onset predict treatment success? Neurorehabil Neural Repair. 2007 Nov-Dec;21(6):561-7. doi: 10.1177/1545968306298412. Epub 2007 Mar 16.
- Background: PubMed 21530732Wilson RD, Bennett ME, Lechman TE, Stager KW, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Arch Phys Med Rehabil. 2011 May;92(5):837-40. doi: 10.1016/j.apmr.2010.11.003.
- Background: PubMed 22920317Wilson RD, Harris MA, Bennett ME, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of shoulder pain from subacromial impingement syndrome. PM R. 2012 Aug;4(8):624-8. doi: 10.1016/j.pmrj.2012.03.002.
- Background: PubMed 22448759Chae J, Wilson RD, Bennett ME, Lechman TE, Stager KW. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case series. Pain Pract. 2013 Jan;13(1):59-67. doi: 10.1111/j.1533-2500.2012.00541.x. Epub 2012 Mar 26.
- 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. This study is not recruiting at the moment.
Mehul Desai, MD, MPH principal investigator
International Spine Pain & Performance Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Shoulder Injuries, run by International Spine, Pain and Performance Center at 2 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 5 inclusion and 10 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 28 Sep 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehul J Desai, MD, MPH (202-808-8295, research@isppcenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in average pain and/or reduction in pain interference (time frame: 3 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 NCT05649917, which also lists 20 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 28 Sep 2023.