An interventional study of ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) and SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio) in Rotator Cuff Repair, Anterior Cruciate Ligament Reconstruction and Ankle Arthrodesis or Arthroplasty, sponsored by University of California, San Diego. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
Among 32 studies in Hallux Valgus with a site in United States — 5 open to participants now, 7 under way, 1 of them phase 3. Hallux Valgus · United States.
Among the 32 studies in Hallux Valgus with a site in United States, this one is the 15th largest by enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2018, is one of 13 with no phase, and was the 12th registered.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
Browse Hallux Valgus studies →5 of the 32 studies in Hallux Valgus with a site in United States are open now. Recruiting first, the newest first:
DePuy Synthes Products, Inc. · Sites in United States
Ages 22+
Rebel Medicine Inc · Sites in United States
Ages 18+
Treace Medical Concepts, Inc. · Sites in United States
Ages 14–65 · Healthy volunteers
Arthrex, Inc. · Sites in United States, Germany, South Africa
Ages 2+ · Healthy volunteers
The International FOP Association · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Hallux Valgus studies recruiting now, 10 (48%) set no upper age limit and 7 (33%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 5 · Phase 3 7
First in 2002; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 65 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Median enrollment 86 across the 24 interventional studies, 61 across the 8 observational. Of the 23 that completed or were terminated, 10 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 32 have an industry lead sponsor. The 10 most frequent:
University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
University of California, San Diego has 4 studies filed under Hallux Valgus — fewer than ten, so there is no comparison to draw.
1 of the studies in Hallux Valgus with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05587569Treace Medical Concepts, Inc.Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D) | 2026-12-31 |
Add it to your calendar (.ics) → With an account.
Among the 32 studies in Hallux Valgus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery.
The current project is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm clinical pilot study to (1) determine the feasibility and optimize the protocol of a planned definitive clinical trial; and (2) estimate the treatment effect of percutaneous PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery compared with usual and customary opioid-based analgesia. This will allow determination of the required sample size for a subsequent definitive multicenter clinical trial. Combined, the pilot study and definitive trial have a strong potential to dramatically reduce or obviate postoperative opioid requirements and their resultant negative effects on both individuals and society; while concurrently improving analgesia, increasing the ability to function in daily life, decreasing the risk of transition from acute to chronic pain, and improving quality of life.
This is a pilot or feasibility study (designated as UG3 by the Department of Defense) which will be a randomized, double-masked, placebo-controlled, parallel-arm, human subjects pilot study with two Specific Aims:
Specific Aim 1 (UG3): To determine the feasibility and optimize the protocol of the Implementation Phase (UH3) multicenter clinical trial that will compare percutaneous PNS with usual and customary opioid-based analgesia following moderate-to-severely painful ambulatory surgery.
Specific Aim 2 (UG3): To estimate the treatment effect of percutaneous PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery compared with usual and customary opioid-based analgesia. This will allow determination of the required sample size of the definitive multicenter clinical trial of the Implementation Phase (UH3).
Anthropomorphic and demographic characteristics as well as baseline end points will be recorded/measured, including a pain score at the surgical site using the Numeric Rating Scale (NRS, 0-10), sensory deficits (measured with von Frey filaments within the cutaneous distribution of the target nerve), and muscle strength (measured with a pressure transducer).
Shoulder • Rotator cuff repair Brachial plexus trunks (lead \& interscalene nerve block)
Knee • Anterior cruciate ligament repair with a patellar autograph Femoral lead \& Adductor canal nerve block
Foot or ankle • Hallux valgus correction or Ankle arthrodesis/ arthroplasty Subgluteal sciatic lead and Popliteal sciatic nerve block
Insulated leads will be inserted prior to peripheral nerve block administration. The lead insertion sites will be cleansed with chlorhexidine gluconate and isopropyl alcohol, and a sterile, fenestrated drape applied. A portable ultrasound paired with either a linear or curved array transducer within a sterile sleeve will be used for lead insertion. The target nerve will be imaged in a transverse cross-sectional (short axis) view and a local anesthetic skin wheal raised lateral to the ultrasound transducer.
A needle and a pre-loaded, monopolar, helically-coiled, insulated lead (SPR Therapeutics, Cleveland, OH) will be inserted. Using an in-plane ultrasound approach, the needle tip will be advanced to the target nerve. The lead will be subsequently attached to an external stimulator (SPR Therapeutics). Accurate lead placement will be confirmed with subject reports of comfortable sensations over the surgical site without eliciting muscle contractions.
Stimulation parameters will be adjusted to improve stimulation coverage and comfort. Once optimum parameters have been determined, the needle will be withdrawn over the lead. The lead will be affixed to the skin with a sterile occlusive dressing. The stimulator will be set to deliver a range of currents. During their treatment, subjects can control these levels. Muscle strength will again be tested with the stimulator set for the optimal setting. The stimulator will be removed until after surgery.
Preoperatively, day of surgery. Subjects will continue to receive usual and customary local anesthetic-based analgesia. Because percutaneous PNS does not induce a sensory block and therefore does not provide anesthesia for the surgical procedure itself, we will continue to provide subjects with a preoperative single-injection local anesthetic-based peripheral nerve block (20 mL of ropivacaine 0.5% with epinephrine 1:400,000). In addition, surgeons will be permitted to infiltrate the surgical area with local anesthetic.
Treatment group assignment (randomization). Subjects will be allocated to a treatment only after confirmation of successfully-inserted electrical leads and surgical procedure initiation; and will be randomized to one of two possible treatment groups:
Randomization will be stratified by institution and anatomic lead location in a 1:1 ratio and in randomly chosen block sizes. Treatment group assignment will be conveyed to the enrolling sites via the same secure web-based system (RedCap) used to collect and collate all post-intervention endpoints. Stimulators are capable of programming to either (1) pass electrical current; or, (2) not pass electrical current. Importantly, these 2 modes (active and sham) are indistinguishable in appearance, and therefore investigators, subjects, and all clinical staff will be masked to treatment group assignment, with the only exception being the unmasked individual who programs the stimulator who will not have contact with the subject following randomization.
Subjects will be informed that often during postoperative active treatment with electrical current patients do not always have the sensations experienced during preoperative lead placement and once proper placement is confirmed with comfortable sensations, therapeutic levels of stimulation may be delivered sub-threshold (below the intensity required for sensation and still provide relief, which is factual/accurate). This protocol will ensure a randomized, double/triple-masked, sham/placebo-controlled trial. For the feasibility study (UG3), unmasking will occur 2 weeks following surgery to allow for protocol revisions, as necessary ("double masked" during initial data collection). In contrast, for the definitive pragmatic clinical trial (UH3) unmasking will not occur until statistical analysis for the entire investigation is complete (termed "triple masked").
Intraoperative course. The primary surgical anesthetic will be a general anesthetic, spinal anesthetic (bupivacaine) or exclusively the preoperative single-injection peripheral nerve block. Anesthetics that are also analgesics such as ketamine will not be used: the only permitted analgesic will be intravenous fentanyl, which will be minimal since all subjects will receive a single-injection peripheral nerve block immediately prior to surgery.
Postoperative course. Within the recovery room following surgery, the stimulators will be attached to the leads and activated, followed by end point assessment. Subjects who had a spinal anesthetic will have end points recorded following spinal resolution. Operating and recovery room pharmacologic analgesic requirements will be recorded.
Prior to discharge, subjects and their caretakers will be provided with verbal and written stimulator/lead instructions and the telephone and pager numbers of a local investigator available at all times. Subjects will be discharged home with their leads in situ. Subjects will be also be discharged with a prescription for an immediate-release oral opioid. Subjects will be contacted by telephone for end point collection (pain and analgesic consumption will be reported by phone on postoperative days 1, 2, 3, 4, 7, 11, and 15 as well as months 1 and 4). Lead removal will occur on postoperative day 14 (+/- 2 days) by healthcare providers. If the lead is removed following Day 14, the stimulator will be turned off on Day 14, and removed subsequently. Following study completion, the results will be mailed electronically or by the United States Postal Service to all enrolled subjects in written form using non-technical language.
Outcome measurements (end points). We have selected outcome measures that have established reliability and validity, with minimal inter-rater discordance, and are recommended for pain-related clinical trials by the World Health Organization and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus statement. Importantly, nearly all outcome measures are common data elements from the National Institute of Neurological Disorders and Stroke (NINDS). End points will be evaluated on postoperative days 0 (baseline), 1, 2, 3, 4, 7, 11, and 15 as well as months 1 and 4).
Demographic and medical history. Subjects will have demographic and anthropomorphic data collected based on NINDS case report form General Core and Demographics Modules and Guidelines, including age, sex, height, weight, educational level, employment status, marital status, and U.S. military service (e.g., none, discharged, active). In addition, the medical history based on the common data elements of the NINDS Medical, Family, Behavioral History, History of Disease/Injury Event, and Prior and Concomitant Medications Sub-Domains will be collected, and include the mechanism of original injury, medications (including analgesics), previous surgical procedures, comorbidities, existing sensory deficits of the target nerve distribution, preoperative pain levels measured on a Numeric Rating Scale for pain (including daily least, average, worst and current), and muscle strength if applicable (measured with a pressure transducer). In addition, since post-traumatic stress disorder (PTSD) may be associated with the severity of pain, at baseline we will apply the PTSD Checklist (PCL-C), a 20-item self-report measure reflecting symptoms of PTSD validated in military, Veteran, and civilian populations.
Data collection. Much of the surgical data from the day of surgery will be extracted from electronic health records to leverage data collection that occurs in health care delivery rather than requiring independent research data collection. Subject demographic, surgical and percutaneous PNS administration data will be uploaded from each enrolling center via the Internet to a secure, password-protected, encrypted central server (RedCap, Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio). All data collection following the day of enrollment (postoperative day 0)-regardless of enrolling center-will be collected by telephone from the University of California San Diego. Staff masked to treatment group assignment will perform all assessments.
UG3 Planning Phase Specific Aims. The investigation described above will accomplish the two Specific Aims of the UG3 Planning Phase:
Specific Aim 1 (UG3): To determine the feasibility and optimize the protocol of the Implementation Phase (UH3) multicenter clinical trial that will compare percutaneous PNS with usual and customary opioid-based analgesia following moderate-to-severely painful ambulatory surgery.
Specific Aim 2 (UG3): To estimate the treatment effect of percutaneous PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery compared with usual and customary opioid-based analgesia. This will allow determination of the required sample size of the definitive multicenter clinical trial of the Implementation Phase (UH3).
** The primary end points will be cumulative opioid consumption and the mean value of the "average" daily surgical pain scores (measured with a Numeric Rating Scale) within the first 7 days following surgery (data collected Days 1, 2, 3, 4, and 7). In order to claim that percutaneous PNS is superior to usual and customary analgesia, at least one of Hypotheses 1 and 2 above must be superior while the other either superior or at least noninferior.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ACTIVE percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electrical current
Device: ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio)
SHAM percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does NOT generate electrical current
Device: SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio)
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does not generate electric current for 14 days
Opioid Consumption During First Postoperative Week
Cumulative opioid dose from days 0-7, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point measured in morphine equivalents
Time frame: Postoperative days 0-7
Average Pain During First Postoperative Week
Mean value of the "average" pain scores measured using the numeric rating scale, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain
Time frame: Postoperative days 0-7
Opioid Consumption Individual Time Points
Cumulative opioid dose of previous 24 hours (measured in morphine equivalents)
Time frame: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4
Brief Pain Inventory, Short Form (Interference Domain)
The Brief Pain Inventory (short form) interference domain is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0 = no interference; 10 = complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The score is calculated by adding the responses for each individual question resulting in a possible range of 0-70 (higher = worse).
Time frame: Postoperative days 3, and 7; as well as Months 1 and 4
Average Pain at Individual Time Points
Mean of the "average" pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Time frame: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4
Worst Pain at Individual Time Points
Median of the worst pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Time frame: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4
Least Pain at Individual Time Points
Least pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Participants were asked "what was the lowest pain within the last 24 hours measured using the 0 to 10 scale, with 0 equal to no pain and 10 equal to the worst imaginable pain"?
Time frame: Postoperative days 3 and 7; as well as Months 1 and 4
Current Pain at Individual Time Points
Current pain scores at the time of the data-collection phone call measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Time frame: Postoperative days 3 and 7; as well as Months 1 and 4
Defense and Veterans Pain Rating Score
Instrument designed to assess pain level specifically for active duty military and Veteran patient populations. It is a Likert scale from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Postoperative days 3, and 7; as well as Months 1 and 4
| Milestone | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Started | 31 | 34 |
| Completed | 30 | 34 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Cumulative opioid dose from days 0-7, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point measured in morphine equivalents
| mg | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Opioid Consumption During First Postoperative Week | 5.0 (0 to 30.0) | 47.5 (25 to 90) |
Mean value of the "average" pain scores measured using the numeric rating scale, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain
| score on a scale | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Average Pain During First Postoperative Week | 1.1 ± 1.1 | 3.1 ± 1.7 |
Cumulative opioid dose of previous 24 hours (measured in morphine equivalents)
| mg | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Postoperative Day 1 | 0 (0 to 100) | 15 (0 to 20) |
| Postoperative Day 2 | 5 (0 to 10) | 20 (10 to 30) |
| Postoperative Day 3 | 0 (0 to 0) | 10 (0 to 20) |
| Postoperative Day 4 | 0 (0 to 0) | 5 (0 to 20) |
| Postoperative Day 7 | 0 (0 to 0) | 0 (0 to 10) |
| Postoperative Day 11 | 0 (0 to 0) | 0 (0 to 5) |
| Postoperative Day 15 | 0 (0 to 0) | 0 (0 to 0) |
| Postoperative Month 1 | 0 (0 to 0) | 0 (0 to 0) |
| Postoperative Month 4 | 0 (0 to 0) | 0 (0 to 0) |
The Brief Pain Inventory (short form) interference domain is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0 = no interference; 10 = complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The score is calculated by adding the responses for each individual question resulting in a possible range of 0-70 (higher = worse).
| units on a scale | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Postoperative Day 3 | 2.6 ± 4.5 | 21.5 ± 17.9 |
| Postoperative Day 7 | 2.5 ± 4.9 | 19.0 ± 17.0 |
| Postoperative Month 1 | 4.0 ± 7.7 | 6.2 ± 10.4 |
| Postoperative Month 4 | 1.6 ± 3.7 | 5.8 ± 12.3 |
Mean of the "average" pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
| score on a scale | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Postoperative Day 1 | 1.8 ± 1.8 | 4.0 ± 2.6 |
| Postoperative Day 2 | 1.3 ± 1.4 | 3.9 ± 2.1 |
| Postoperative Day 3 | 0.9 ± 1.2 | 3.1 ± 2.3 |
| Postoperative Day 4 | 0.7 ± 1.2 | 2.3 ± 2.0 |
| Postoperative Day 7 | 0.6 ± 1.1 | 1.9 ± 2.1 |
| Postoperative Day 11 | 0.3 ± 0.2 | 1.7 ± 1.4 |
| Postoperative Day 15 | 0.9 ± 0.6 | 1.9 ± 1.6 |
| Postoperative Month 1 | 0.5 ± 0.8 | 1.3 ± 1.8 |
| Postoperative Month 4 | 0.3 ± 0.9 | 0.8 ± 1.7 |
Median of the worst pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
| score on a scale | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Postoperative Day 1 | 4 (0 to 6) | 7.8 (3 to 9) |
| Postoperative Day 2 | 4 (2 to 6) | 7.5 (5 to 9) |
| Postoperative Day 3 | 3 (0 to 4) | 6 (4 to 8) |
| Postoperative Day 4 | 1.3 (0 to 4) | 4.3 (3 to 7) |
| Postoperative Day 7 | 1.8 (0 to 3.5) | 3.5 (3 to 5) |
| Postoperative Day 11 | 0.5 (0 to 2) | 3 (1 to 5) |
| Postoperative Day 15 | 1.0 (0 to 5) | 2 (0 to 4.5) |
| Postoperative Month 1 | 3.0 (0 to 4) | 2 (0 to 4) |
| Postoperative Month 4 | 0 (0 to 1) | 1.5 (0 to 3) |
Least pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Participants were asked "what was the lowest pain within the last 24 hours measured using the 0 to 10 scale, with 0 equal to no pain and 10 equal to the worst imaginable pain"?
| score on a scale | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Postoperative Day 3 | 0.2 ± 0.6 | 1.4 ± 1.8 |
| Postoperative Day 7 | 0.2 ± 0.7 | 0.7 ± 1.6 |
| Postoperative Month 1 | 0.1 ± 0.3 | 0.5 ± 1.0 |
| Postoperative Month 4 | 0.3 ± 0.2 | 0.4 ± 1.2 |
Current pain scores at the time of the data-collection phone call measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
| score on a scale | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Postoperative Day 3 | 0.4 ± 0.7 | 2.3 ± 2.3 |
| Postoperative Day 7 | 0.3 ± 0.8 | 1.5 ± 2.2 |
| Postoperative Month 1 | 0.3 ± 0.8 | 1.0 ± 1.8 |
| Postoperative Month 4 | 0.1 ± 0.6 | 0.4 ± 0.9 |
Instrument designed to assess pain level specifically for active duty military and Veteran patient populations. It is a Likert scale from 0 (no pain) to 10 (worst imaginable pain).
| score on a scale | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Postoperative Day 3 | 1.4 ± 1.5 | 4.2 ± 2.3 |
| Postoperative Day 7 | 1.1 ± 1.5 | 2.9 ± 2.5 |
| Postoperative Month 1 | 1.3 ± 1.4 | 1.5 ± 2.0 |
| Postoperative Month 4 | 0.6 ± 1.4 | 1.2 ± 1.7 |
Collected over 4 months following surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peripheral Nerve Stimulation | 0/31 (0%) | 0/31 (0%) | 2/31 (6.5%) |
| Sham | 0/34 (0%) | 0/34 (0%) | 1/34 (2.9%) |
| Event | Peripheral Nerve Stimulation | Sham |
|---|---|---|
| Lead fracture during purposeful removalMusculoskeletal and connective tissue disorders | 1/31 | 1/34 |
| Adhesive reactionMusculoskeletal and connective tissue disorders | 1/31 | 0/34 |
| Age, Continuous(years) | Peripheral Nerve Stimulation | Sham | Total |
|---|---|---|---|
| Mean | 57 ± 16 | 55 ± 16 | 56 ± 16 |
| Sex: Female, Male(Participants) | Peripheral Nerve Stimulation | Sham | Total |
|---|---|---|---|
| Female | 15 | 17 | 32 |
| Male | 16 | 17 | 33 |
| Race and Ethnicity Not Collected(Participants) | Peripheral Nerve Stimulation | Sham | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Peripheral Nerve Stimulation | Sham | Total |
|---|---|---|---|
| United States | 31 | 34 | 65 |
| Height(cm) | Peripheral Nerve Stimulation | Sham | Total |
|---|---|---|---|
| Mean | 172 ± 11 | 174 ± 10 | 173 ± 10 |
| Weight(kg) | Peripheral Nerve Stimulation | Sham | Total |
|---|---|---|---|
| Mean | 80 ± 16 | 86 ± 20 | 83 ± 18 |
| Body Mass Index(kg/m^2) | Peripheral Nerve Stimulation | Sham | Total |
|---|---|---|---|
| Mean | 27 ± 4 | 29 ± 5 | 28 ± 5 |
| Years of education(years) | Peripheral Nerve Stimulation | Sham | Total |
|---|---|---|---|
| Mean | 17 ± 3 | 16 ± 3 | 17 ± 3 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Sep 2020, 25 months.
Results were first posted in Mar 2021, 6 months after primary completion.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's 25 months is close to that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University of California, San Diego →