Abstract
Introduction
Low back pain (LBP) is a leading cause of disability worldwide, and treatment often necessitates invasive interventions that carry significant risks and economic burdens. While prior studies demonstrated durable benefit following percutaneous 60-day peripheral nerve stimulation (PNS), real-world data are needed to characterize long-term outcomes across routine clinical practice. This survey evaluated the durability of patient-reported improvements among a real-world cohort of patients with LBP who responded to 60-day PNS.
Methods
A cross-sectional follow-up survey was administered to patients who previously responded to 60-day PNS targeting the lumbar medial branch nerves. Outcomes assessed included patient-reported percent pain relief and impression of change in quality of life (QoL), physical function, mood, and sleep. Participants also reported use or avoidance of other LBP treatments or interventions since completing 60-day PNS.
Results
The survey was completed by 602 participants, with follow-up durations ranging from 6 to 68 months. Overall, 79% (475/602) of participants required no radiofrequency ablation (RFA), permanent implant, or surgery following 60-day PNS. Among participants who avoided subsequent interventions, 79% (376/475) reported durable improvements in at least one domain (≥ 50% pain relief and/or clinically meaningful improvement of QoL, physical function, mood, and/or sleep) at follow-up. Among participants without a prior permanent neurostimulator implant, 92% (309/336) of those who sought to avoid permanent implantation succeeded. Among those without prior low back surgery who wanted to avoid it, 95% (353/370) avoided surgery through follow‑up.
Conclusions
These findings suggest that patients with LBP who respond to percutaneous 60-day PNS may experience durable relief, with benefits sustained by some for 5+ years. Participants reported reductions in pain leading to improvements in other health domains, and avoidance of subsequent interventions, including surgery, permanent implants, and/or RFA, through long-term follow-up, highlighting the potential use of percutaneous 60-day PNS as a minimally invasive, short-term treatment capable of producing long-lasting benefits in patients with LBP.
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1007/s40122-026-00858-3.
Keywords: Chronic low back pain, Chronic pain, Neuromodulation, Percutaneous peripheral nerve stimulation, Peripheral nerve stimulation
Key Summary Points
| Why carry out this study? | |
| Chronic low back pain (LBP) is associated with substantial clinical and economic burden, and while prior randomized and prospective studies have demonstrated durable benefits following percutaneous 60-day peripheral nerve stimulation (PNS) as a short-term treatment with potential for lasting relief of LBP, this study addresses the need for real-world evidence of long-term treatment durability. | |
| This study evaluated whether patients with chronic LBP who initially responded to 60-day PNS experienced durable long‑term improvements and explored their patterns of progression to interventions such as radiofrequency ablation (RFA), permanent neurostimulator implant, and surgery. | |
| What was learned from the study? | |
| Among 602 participants in this cross-sectional survey, 79% reported no subsequent RFA, permanent neurostimulator implant, or low back surgery through long-term follow-up after 60‑day PNS, and 79% of those avoiding subsequent interventions reported durable improvement in at least one health domain. | |
| These findings extend prior prospective and observational studies by further characterizing long-term durability of patient-reported outcomes and treatment trajectories following 60-day PNS across a large real-world cohort. | |
| Consistent with prior studies, the results support the role of percutaneous 60‑day PNS as a minimally invasive, short-term treatment option with potential to provide durable clinical benefits for up to 5+ years, with many patients reporting avoidance of subsequent interventions. |
Introduction
Low back pain (LBP) is a leading cause of disability worldwide and the management of LBP represents an increasingly large clinical and societal burden [1–3]. The economic impact of chronic LBP is correspondingly large, reflecting direct healthcare spending and substantial indirect costs from lost productivity [4–7], and the USA experiences the highest cost burden internationally [8]. In a comprehensive analysis of US health spending by condition, low back and neck pain represented the largest spending category among 154 conditions in 2016, estimated at $134.5 billion [6]. Claims-based studies further demonstrate high comorbidity levels, frequent healthcare encounters, and increased medication utilization among patients with chronic LBP in real-world practice [7].
Despite their broad use and demonstrated benefit in well-selected patient populations, commonly used treatments for chronic LBP may provide limited relief for some individuals, and outcomes can vary in routine clinical practice. Contemporary care pathways emphasize education, exercise-based therapy, and judicious pharmacologic management as foundational components of care for many patients [9, 10], with interventional procedures such as radiofrequency ablation (RFA), permanently implanted neurostimulation, or surgery considered for patients with persistent symptoms. While these interventions can provide meaningful benefit, some patients continue to experience ongoing pain or functional limitation over time [11, 12], highlighting the need for additional treatment options that may provide durable benefit without requiring repeated procedures or permanent implantation.
Within contemporary care pathways for chronic LBP, percutaneous 60‑day peripheral nerve stimulation (PNS) is a minimally invasive neurostimulation treatment in which fine‑wire percutaneous leads are temporarily implanted for up to 60 days, with a goal of producing lasting pain relief without a need for permanent implantation. This treatment is supported by recent analyses demonstrating that percutaneous 60‑day PNS can provide clinically meaningful and statistically significant reductions in pain that are sustained long‑term [13, 14], and its use as an effective treatment for chronic pain is endorsed by leading physician society guidelines [15–17]. Percutaneous 60-day PNS targeting the lumbar medial branch nerves has been shown to provide clinically and statistically significant improvements in pain and secondary end points in multiple prospective clinical studies of participants with chronic LBP, including a prospective multicenter cohort study [18–20] and a recent multicenter randomized controlled trial (RCT) comparing 60-day PNS with standard interventions for LBP [21]. Long-term follow-up from the multicenter cohort study revealed evidence of sustained benefit for more than 4 years after treatment with 60-day PNS [20]. Durable patient outcomes and high rates of intervention avoidance several years after percutaneous 60-day PNS have been reported in large real-world shoulder pain cohorts [22]; however, evaluations with extended follow-up remain limited in larger real-world populations treated for LBP. Prior healthcare–economic modeling suggests that introducing 60-day PNS earlier within interventional care pathways for LBP may provide cost-savings by reducing progression to higher-cost or repeated procedures [23], supporting the need for this real-world analysis.
The objective of this cross-sectional survey study was to characterize real-world, long-term durability of patient-reported outcomes among patients with chronic axial LBP who previously responded to treatment with percutaneous 60-day PNS targeting the lumbar medial branch nerves. Additional goals included exploring patterns of progression to interventions such as RFA, permanent neurostimulator implant, and surgery and assessing benefit among patients who avoided additional interventions during the long-term follow-up after responding to percutaneous 60-day PNS. While prior studies have demonstrated clinically meaningful benefits with 60‑day PNS, this report explores long‑term patient outcomes and subsequent real‑world treatment utilization patterns after percutaneous 60-day PNS in LBP, which may provide important context for evidence‑based clinical decision‑making regarding the use of 60‑day PNS.
Methods
Study Design and Participant Eligibility
This study administered a cross-sectional follow-up survey to patients with axial LBP who previously received treatment with percutaneous 60-day PNS (SPRINT® PNS System, SPR®, Cleveland, OH, USA). Patients were considered eligible for follow-up survey participation if they reported ≥ 50% pain relief at the end of percutaneous 60-day PNS treatment with two leads targeting the lumbar medial branch nerves, did not have documented confounding factors contributing to pain, had not opted out of communications from the device manufacturer, and provided an email address and/or phone number. The study was approved by the WIRB-Copernicus Group Institutional Review Board (WCG-IRB, #20242073) with a waiver of documentation of informed consent. The survey included a consent agreement that acknowledged the use of deidentified survey data for research purposes. The study was performed in accordance with relevant portions of the Declaration of Helsinki. Based on NIH and NLM guidance, this cross-sectional follow-up survey of patients who had already completed treatment was not subject to prospective registration requirements and was not prospectively registered in a clinical trial or observational study registry [24]. Consistent with the observational design and focus on pain-related outcomes, this study has been reported in accordance with applicable guidelines and IMMPACT recommendations for reporting observational studies on chronic pain [25, 26].
Percutaneous 60-Day PNS for Low Back Pain
All survey participants had axial LBP that was previously treated with percutaneous 60-day PNS at least 6 months prior to follow-up survey participation. This treatment involves percutaneous placement of fine-wire open-coil leads (MicroLeadTM, SPR®, Cleveland, OH, USA), often under fluoroscopic or ultrasound guidance, to target the lumbar medial branch nerves. Leads are connected to an external wearable pulse generator delivering electrical stimulation for up to 60 days (typical parameters: frequency = 12 Hz, duty cycle = 50%, stimulation time = 6–12 h/day), after which the percutaneous leads are removed in an outpatient procedure by applying gentle traction to the externalized portion of the lead.
Survey Administration
This study’s methodology was designed to align with established mixed-mode approaches for administering the survey (i.e., combining web-based survey invitations delivered by email or text message with telephone follow-up) that have been successfully used in prior real-world cross-sectional follow-up surveys of patients with percutaneous 60-day PNS [22]. Patients who met criteria for survey inclusion and had an active mobile number on file received a brief prenotification text message up to 3 days prior to the launch of the survey to inform them of the upcoming opportunity to participate in the study. Each survey recipient received up to three text messages and/or up to three email invitations to participate over the survey administration period, which was up to approximately 1 month for each participant. Survey recipients who declined survey participation were exited from the survey and were excluded from further contact and analysis. At any time, recipients could opt out of future text or email communications related to the survey. For individuals who did not respond to electronic outreach, one telephone call attempt was made by a study representative. Whenever possible, a voicemail was left reminding the patient of the text message and/or email invitations to participate in the survey. Those who responded to the telephone call or voicemail were also offered the option to complete the survey by telephone. For participants who completed the survey by telephone, a trained study representative followed a standardized script that reviewed the study purpose, voluntary participation, confidentiality, and compensation prior to confirming willingness to participate and administering the survey. Participants who completed the survey received a US $100 electronic gift card that was IRB-approved as compensation for their time and participation.
Outcome Measures and Analysis Methods
Survey responses were collected from individuals who were at least 6 months beyond the start of their 60‑day PNS treatment. Participants had previously agreed (via written or electronic authorization) at the start of 60-day PNS to provide baseline characteristics, details about their 60-day PNS treatment, and end of treatment (EOT) outcomes, and their survey responses were subsequently linked with these preexisting database records.
The long-term follow-up survey collected patient‑reported outcomes using validated pain and functional measures. Participants rated their average pain over the past week (Brief Pain Inventory Short Form, item 5; BPI‑5) and their worst pain (BPI‑3) using an 11‑point numerical rating scale. They also reported their overall percentage pain relief at the time of survey completion (BPI‑8), scored from 0 to 100%, relative to before 60-day PNS. Perceived changes in quality of life (QoL), physical function, mood, and sleep were assessed using a 7‑point patient impression of change scale, ranging from very much worse to very much improved. The primary end point for the survey was prospectively defined as the proportion of patients with ≥ 30% pain relief and/or clinically significant improvement in QoL (at least minimally improved) at the time of survey completion, stratified by the duration of time elapsed since beginning 60-day PNS treatment. Participants were also asked to report demographic information, the underlying causes of LBP, and any interventions received in the time since completing 60‑day PNS. All participants who previously used pain medications for LBP were asked to qualitatively describe whether their use of analgesic medications had increased, decreased, stopped, or remained unchanged relative to their usage before 60-day PNS treatment.
Additional patient‑reported outcomes included overall satisfaction with 60‑day PNS treatment, assessed on a 5‑point scale ranging from very dissatisfied (1) to very satisfied (5). Participants who were working before or after 60‑day PNS and who reported that pain affected their work were also asked to rate changes in work attendance and work productivity using the same 7‑point patient impression of change scale used for other functional domains.
To evaluate long‑term outcomes, participants were grouped into three categories. Long‑term responders were defined as individuals demonstrating sustained benefit in at least one of five domains—pain relief of ≥ 50% and/or clinically meaningful improvement (i.e., at least minimally improved) in QoL, physical function, mood, or sleep—while also reporting no progression to further interventional treatments such as RFA, permanent neurostimulator implantation, or low back surgery. Long‑term nonresponders were those who did not maintain clinically meaningful improvement in any domain but likewise reported no additional interventions. A third group consisted of participants who required additional interventions following percutaneous 60‑day PNS treatment. Conservative therapies, including physical rehabilitation and integrative modalities, were considered supportive or adjunctive in nature and were therefore not classified as evidence of treatment escalation or advancement within the conventional interventional algorithm.
As a follow-up survey administered long after percutaneous 60-day PNS completion, safety outcomes were not directly collected or adjudicated in this study. The safety profile of percutaneous 60-day PNS has been well-characterized across multiple prospective clinical trials and real-world studies [13, 21, 27, 28]. Accordingly, the present analysis was designed to focus on long-term durability of clinical benefit. All data are summarized descriptively and reported as means (standard deviation, SD) or as proportions of survey participants (confidence interval, CI). Analyses were conducted using available data for each outcome. Participants without responses for a given survey item were excluded from analyses of that specific outcome but were retained for analyses of other outcomes for which data were available. No imputation was performed for missing survey responses. Accordingly, sample size (n) varied across reported outcomes based on item-level response completeness.
Results
Demographics and LBP Treatment History
A total of 1346 patients received the cross-sectional survey from May to July 2025 and did not opt out of participation. A total of 12 of these survey recipients were later found not to be eligible and were excluded from further analysis, including four who completed the survey. A total of 602 eligible participants completed the survey and were included in the analysis. The resulting survey completion rate was therefore 45% overall (602/1334) (Supplementary Fig. S1). Participants that provided both an email address and a phone number at the time of 60-day PNS treatment were 24% more likely to complete the survey than those who only provided a single mode of communication, underscoring the importance of a multimodal approach for maximizing response in the long-term follow-up survey.
Survey participant demographics are summarized in Table 1, with baseline LBP severity summarized in Table 2. Baseline LBP intensity prior to percutaneous 60-day PNS was moderate-to-severe on average (Table 2). The underlying causes of LBP differed across participants, with many indicating multiple contributing causes, and was most frequently attributed to lumbar spondylosis or facet arthropathy, degenerative disc disease, or spinal stenosis (Table 2). Patients with documented confounding factors contributing to LBP (e.g., radicular pain, postoperative pain, etc.) at implant were excluded from participation in the survey on the basis of baseline screening; however, in the long-term follow-up survey, some participants reported LBP caused by prior lumbar surgery and sacroiliac joint dysfunction, and these responses were retained in the analysis.
Table 1.
Participant demographics
| Total survey participants | n = 602 |
| Age, years, mean (SD) | 65 (14) |
| Sex | |
| Female, % (n) | 60% (364) |
| Male, % (n) | 39% (235) |
| Prefer not to answer, % (n) | < 1% (3) |
| Racea | |
| American Indian/Alaskan Native, % (n) | 2% (14) |
| Asian, % (n) | < 1% (5) |
| Black/African American, % (n) | 12% (73) |
| Native Hawaiian/Pacific Islander, % (n) | < 1% (1) |
| White, % (n) | 80% (479) |
| Prefer not to answer, % (n) | 7% (41) |
| Ethnicity | |
| Hispanic or Latino, % (n) | 7% (42) |
| Not Hispanic or Latino, % (n) | 88% (528) |
| Prefer not to answer, % (n) | 5% (32) |
“Prefer not to answer” includes participants who selected that response as well as those who left the optional field blank
SD standard deviation
aParticipants had the ability to select multiple items, as applicable
Table 2.
Low back pain severity, reported causes, and prior interventions
| Baseline average LBP score, mean (SD) | 6.0 (1.9) |
| Baseline worst LBP score, mean (SD) | 8.7 (1.4) |
| Participant-reported cause of LBPa | |
| Lumbar spondylosis/facet arthropathy, % (n) | 51% (305) |
| Degenerative disc disease, % (n) | 47% (285) |
| Spinal stenosis, % (n) | 33% (196) |
| Injury/trauma, % (n) | 20% (119) |
| Previous low back surgery, % (n) | 10% (59) |
| Sacroiliac joint dysfunction, % (n) | 7% (43) |
| Other/unsure, % (n) | 23% (140) |
| Participant-reported prior LBP treatmenta | |
| Number of prior treatment types, mean (SD) | 3.5 (1.6) |
| Prior Treatment Types | |
| Non-opioid medication, % (n) | 57% (341) |
| Opioid medication, % (n) | 44% (264) |
| Chiropractor, % (n) | 34% (203) |
| Physical therapy, % (n) | 71% (425) |
| Injection or nerve block, % (n) | 74% (445) |
| Radiofrequency ablation (RFA) | 42% (250) |
| Permanent neurostimulator implant (e.g., PNS, SCS, etc.), % (n) | 5% (33) |
| Low back surgery, % (n) | 13% (76) |
| No other treatments, % (n) | 3% (19) |
| Other/unsure, % (n) | 7% (45) |
All proportions are from total survey participants (n = 602)
LBP low back pain, SD standard deviation, PNS peripheral nerve stimulation, SCS spinal cord stimulation
aParticipants had the ability to select multiple items as applicable
Table 2 includes a summary of participant-reported use of LBP treatments prior to percutaneous 60-day PNS. An average of 3.5 (SD 1.6) prior LBP treatment types were reported per participant, with 87% (524/602) indicating use of two or more treatment types before percutaneous 60-day PNS. Common treatments included injections or nerve blocks, physical therapy, nonopioid medications, opioid medications, and chiropractic care. A notable share of participants reported prior use of interventions, including RFA and permanent neurostimulator implants such as PNS or spinal cord stimulation (SCS) trials or systems, before undergoing percutaneous 60-day PNS. A minority of participants reported having undergone lumbar surgery as treatment for their LBP prior to 60-day PNS, and many of these participants also reported prior lumbar surgery as an underlying cause of their LBP at the time they received 60-day PNS.
In addition to analyzing participant responses in aggregate, results are also presented as cohorts stratified by duration of follow-up, ranging from 6–11, 12–17, 18–23, 24–35, 36–47, and 48–68 months from their 60-day PNS treatment (start of treatment, SOT; Table 3). Because the survey captured a single cross-sectional time point for each participant, these groups are mutually exclusive and reflect differences in time since treatment at the time of survey completion. Accordingly, the number of participants within each interval varied based on when individuals were treated and subsequently responded to the survey. Across all surveyed participants, the mean follow-up duration was 26 months (SD 14). The majority of participants completed follow‑up multiple (≥ 2) years after SOT (51%, n = 308), and these participants had a mean follow‑up duration of 37 months (SD 10).
Table 3.
Distribution of participants by time to cross-sectional follow-up after 60-day PNS
| 6–11 months, % (n) | 16% | (98) |
| 12–17 months, % (n) | 15% | (93) |
| 18–23 months, % (n) | 17% | (103) |
| 24–35 months, % (n) | 27% | (160) |
| 36–47 months, % (n) | 16% | (98) |
| 48–68 months, % (n) | 8% | (50) |
All proportions are from total survey participants (n = 602)
PNS peripheral nerve stimulation
Long-Term Patient Reported Outcomes
Among all survey participants, 79% (475/602, 95% CI = 76–82%) reported that they had not undergone RFA, a permanent neurostimulator implant, or low back surgery since treatment with 60-day PNS. The remaining 21% (127/602, 95% CI = 18–24%) indicated that they had received one or more of these procedures. Among all survey participants, 12% (n = 74) underwent RFA, 7% (n = 41) received a permanent implant, and 5% (n = 28) reported progression to subsequent low back surgery in the up to 5 years following 60-day PNS. Among participants who reported the timing of subsequent interventions, 48% (58/121, 95% CI = 39–57%) of the interventions occurred at least 1 year after 60-day PNS.
Among participants who avoided progression to subsequent interventions, 79% (376/475, 95% CI = 76–83%) were long‑term responders who reported sustained improvement in at least one health domain, including ≥ 50% pain relief and/or clinically meaningful improvement (defined as at least minimally improved) in QoL, physical function, mood, or sleep. Long‑term responders reported a mean pain relief of 53% (SD 33%). Long-term responders frequently reported improvement across multiple domains, as 87% (327/376, 95% CI = 84–90%) improved in at least two domains, and 70% (262/376, 95% CI = 65–74%) improved in at least four of five domains. These proportions were consistent across follow‑up periods (Fig. 1). Sustained reductions in both average and worst pain scores from EOT to follow‑up were also observed among long‑term responders, with mean average pain decreasing from 6.1 (SD 1.9) at baseline to 4.0 (SD 2.4) at follow‑up and mean worst pain decreasing from 8.7 (SD 1.3) at baseline to 5.2 (SD 2.9) at follow‑up.
Fig. 1.
A: the proportions of survey participants who reported no subsequent interventions at long-term follow-up after responding to percutaneous 60‑day peripheral nerve stimulation (PNS), including no radiofrequency ablation (RFA), permanent neurostimulator implantation, or surgery, grouped by months from the start of treatment. B: the proportions of participants within each follow-up group who avoided RFA, permanent neurostimulator implant, and surgery after 60-day PNS and met the criteria for being long-term responders by reporting durable improvement in at least one domain*: ≥ 50% patient-reported percent pain relief and/or clinically meaningful improvement (i.e., at least minimally improved) in quality of life (QoL), physical function, mood, or sleep. Data presented as population percentage and 95% confidence intervals
Among those without subsequent intervention, 71% (338/475, 95% CI = 67–75%) met the study’s prospectively defined primary end point by reporting ≥ 30% pain relief and/or improvement in QoL (at least minimally improved). In addition, 67% (316/475, 95% CI = 62–71%) of those who avoided subsequent interventions reported ≥ 50% pain relief and/or at least minimally improved QoL (Fig. 2). Most participants also reported clinically meaningful improvements in QoL (65%, 307/475, 95% CI = 60–69%) and physical function (63%, 301/475, 95% CI = 59–68%). When participants who had reported that pain impacted their mood or sleep at baseline were asked to evaluate changes in those domains at follow-up, 59% (250/421, 95% CI = 55–64%) noted improvement in mood and 57% (230/407, 95% CI = 52–61%) reported improvement in sleep. Across all domains, impressions of change showed consistent patterns across different follow‑up durations. Among participants who used analgesic medications at baseline, 81% (352/435, 95% CI = 77–85%) reported that medication usage was maintained, reduced, or discontinued at long-term follow-up relative to pre‑PNS levels (Fig. 3).
Fig. 2.
The proportions of participants (grouped by time of follow-up in months from the start of treatment) who avoided interventions after percutaneous 60-day peripheral nerve stimulation (PNS) and reported ≥ 50% pain relief and/or at least minimally improved quality of life (QoL) at the time of follow-up. Data presented as population percentage and 95% confidence intervals
Fig. 3.
Proportions of participants avoiding subsequent intervention who reported changes in pain medication use at follow‑up relative to before 60‑day peripheral nerve stimulation (PNS) treatment, stratified by months from the start of treatment
Avoidance of interventions after 60-day PNS appeared consistent across patient-reported causes of LBP (Table 4). Among those who avoided subsequent interventions, sustained clinically significant improvement in at least one domain was observed at similar rates across causes of LBP (Table 4).
Table 4.
Patient-reported intervention avoidance and long-term responder rates stratified by cause of LBP
| Cause of LBP | No interventionsa | Long-term respondersc |
|---|---|---|
| After 60-day PNSb | ||
| Lumbar spondylosis/facet arthropathy, % (n) | 75% (230/305) | 79% (181/230) |
| Degenerative disc disease, % (n) | 78% (222/285) | 80% (178/222) |
| Spinal stenosis, % (n) | 73% (143/196) | 81% (116/143) |
| Injury/trauma, % (n) | 79% (94/119) | 82% (77/94) |
| Previous low back surgery, % (n) | 69% (41/59) | 78% (32/41) |
| Sacroiliac joint dysfunction, % (n) | 79% (34/43) | 76% (26/34) |
| Other/unsure, % (n) | 82% (115/140) | 73% (84/115) |
| All causes of LBP, % (n) | 79% (475/602) | 79% (376/475) |
aNo radiofrequency ablation, permanent neurostimulator implantation, or surgery
bProportions of participants with a given cause of LBP who had no subsequent interventionsa
cProportions of participants with a given cause of LBP who both had no subsequent interventionsa and reported durable improvement in at least one domain: ≥ 50% patient-reported percent pain relief and/or clinically meaningful improvement (i.e., at least minimally improved) in quality of life, physical function, mood, or sleep
Permanent Implant Avoidance
Participants who did not have a prior permanent neurostimulator implant (n = 569) were asked to report whether they were using percutaneous 60-day PNS to avoid progression to permanently implanted stimulation. In this cohort, 59% (336/569, 95% CI = 55–63%) reported wanting to avoid a permanent implant and 92% (309/336, 95% CI = 89–95%) of those successfully avoided a permanent implant after 60-day PNS (Fig. 4). Within this group of participants avoiding a permanent implant, 84% (259/309, 95% CI = 80–88%) were long-term responders with clinically significant improvement in at least one domain and reported an average pain relief of 56% (SD 31%) at a mean follow-up duration of 25 (SD 14) months.
Fig. 4.
Proportions of participants without prior permanently implanted stimulation (A) or low back surgery (B) who wanted to avoid progression to these interventions after percutaneous 60-day peripheral nerve stimulation (PNS) and successfully avoided them through follow-up. Of the 59% (95% confidence interval [CI] = 55–63%) of participants who wanted to avoid permanently implanted stimulation, 92% (95% CI = 89–95%) successfully avoided it at follow-up. Among the 72% (95% CI = 68–76%) of participants who wanted to avoid low back surgery, 95% (95% CI = 93–98%) avoided it through follow-up. Within these sub-groups, 84% (95% CI = 80–88%) of those who avoided permanent neurostimulator implant and 83% (95% CI = 79–87%) of those who avoided low back surgery through follow-up reported durable improvements in at least one domain: ≥ 50% patient-reported percent pain relief and/or clinically meaningful improvement (i.e., at least minimally improved) in quality of life (QoL), physical function, mood, or sleep
Participants who avoided permanent implantation also tended to refrain from other subsequent interventional treatments. Among this group, 96% (297/309, 95% CI = 94–98%) did not undergo low back surgery after the 60‑day PNS treatment, and 88% (271/309, 95% CI = 84–91%) did not receive RFA. Medication use showed similar trends, as 85% (262/309, 95% CI = 81–89%) reported no initiation of new pain medications and 54% (157/290, 95% CI = 48–60%) of those who were using pain medication prior to 60‑day PNS treatment reported that they had reduced or discontinued medication use compared with their pre‑PNS baseline.
Surgery Avoidance
Participants who did not have prior low back surgery (n = 514) were asked to report whether they were using percutaneous 60-day PNS to avoid progression to low back surgery. Among the 72% (370/514, 95% CI = 68–76%) who wanted to avoid surgery, 95% (353/370, 95% CI = 93–98%) successfully avoided low back surgery after 60-day PNS (Fig. 4). In this group of participants avoiding low back surgery, 83% (293/353, 95% CI = 79–87%) were long-term responders with clinically significant improvement in at least one domain and reported an average pain relief of 53% (SD 32%) at a mean follow-up duration of 24 (SD 14) months.
Among participants who did not undergo low back surgery after the 60‑day PNS treatment, 93% (330/353, 95% CI = 91–96%) did not proceed to a permanent neurostimulator implant and 88% (312/353, 95% CI = 85–92%) did not receive RFA. This pattern extended to medication use, with 85% (299/353, 95% CI = 81–88%) reporting no initiation of new pain medications. Furthermore, 50% (165/330, 95% CI = 45–55%) of prior pain medication users reported that they reduced or discontinued medications compared with pre‑PNS levels.
Satisfaction and Other Outcomes
Treatment satisfaction, assessed on a 5‑point scale ranging from very dissatisfied (1) to very satisfied (5), was highest among long-term responders (4.1 [SD 1.0], n = 376) relative to long-term nonresponders (2.3 [SD 1.1], n = 99) and the participants who advanced to subsequent intervention after 60-day PNS (3.5 [SD 1.2], n = 127). High satisfaction ratings were reported both by participants who sought to avoid and successfully avoided permanent neurostimulator implantation (3.9 [SD 1.2], n = 309) and by participants who sought to avoid and successfully avoided low back surgery (3.9 [SD 1.2], n = 353). Participants who were working before and/or after 60-day PNS were asked to report whether pain affected their work prior to the treatment. Among those with work-related pain who avoided subsequent interventions, 71% (84/118, 95% CI = 63–79%) reported improved work attendance and/or productivity at follow-up, including 49% (58/118, 95% CI = 40–58%) who noted much to very much improvement in either metric.
Discussion
This large cross-sectional study of patients with chronic LBP who initially responded to percutaneous 60-day PNS of the lumbar medial branch nerves suggests that the short-term treatment can produce sustained, multi-domain improvements, with the durability extending to more than 5 years in some participants. Overall responder rates for percutaneous 60-day PNS have been reported previously in both real-world and prospective studies, as in Huntoon et al. (2023), where approximately 65% of n = 1977 patients receiving lumbar medial branch PNS reported ≥ 50% pain relief and/or improvement in quality of life [29]. The present analysis focuses on the clinically relevant question of long-term durability and subsequent treatment among those who initially responded to treatment. In this real-world cohort, 79% of participants avoided progression to RFA, permanent neurostimulation implantation, or low back surgery in the up to 5+ years after 60-day PNS, and 79% of those who avoided subsequent interventions were long-term responders reporting durable improvements in one or more domains of pain relief, QoL, physical function, mood, and/or sleep. Participants who were long-term responders averaged 53% pain relief. The improvements were also robust across individual domains, as majorities of participants with no subsequent interventions reported ensuing clinically meaningful improvements in QoL (65%), physical function (63%), mood (59%), and sleep (57%) at follow-up. Together, these results provide strong real-world evidence that percutaneous 60-day PNS can provide long-lasting improvements in pain leading to improvements in other health domains that persist well beyond the short stimulation period.
The multi-domain nature of the improvements observed in this study is consistent with secondary end points from prior prospective multicenter studies, including an RCT for 60-day PNS in chronic LBP [18–21]; this report complements that evidence by demonstrating durability across a substantially larger real-world cohort that includes patients with a range of underlying causes of LBP. Most study participants reported improvements in QoL, physical function, mood, and sleep, with 70% of long-term responders reporting improvement in four or more domains, demonstrating the therapeutic impact of 60-day PNS extends beyond pain reduction alone.
A common challenge in chronic LBP is the progression through multiple therapeutic approaches when symptoms persist, including escalation from conservative care to interventional procedures or surgery for some patients [7, 9–11, 30]. The present study provides real-world data on outcomes and patterns of intervention use following percutaneous 60-day PNS in patients with chronic LBP, offering insight into subsequent care pathways reported by treatment responders over extended follow-up periods of up to 5 years. In this cohort, 79% of participants reported no subsequent RFA, permanent neurostimulation implant, or low back surgery following 60-day PNS. Building on prior studies showing that many patients treated with 60-day PNS do not proceed to additional interventional or surgical treatments [20, 22], the present study extends this literature by characterizing durability of patient-reported outcomes and subsequent treatment use in a large real-world cohort treated for chronic axial LBP in routine clinical practice. Participants in this study who sought to avoid progression to permanent neurostimulation implantation or low back surgery frequently did so, with 92% and 95%, respectively, reporting avoidance of these interventions in follow-up. The findings related to LBP treatment progression reported here may also be relevant to healthcare utilization, as LBP is associated with substantial population-level economic burden [5, 31], and provide real-world context that use of 60‑day PNS has potential to influence subsequent healthcare expenditures [23].
Medication usage patterns were typically stable or reduced in long-term follow-up, with 81% of participants who used analgesics prior to 60-day PNS reporting maintained, reduced, or discontinued use at follow-up, including 46% who reduced or stopped pain medications entirely, suggesting that the reported improvements were not driven by increased medication use. This pattern of reporting reduced medication usage corroborates the durable reductions in pain severity and the improvement observed across QoL and other health-related domains, highlighting the potential complementary role of PNS in reducing reliance on pharmacologic therapy [27, 32].
The benefits reported by study participants also extended to work‑related outcomes. Among participants who were working before or after treatment and whose pain affected work, 71% reported improvement in work attendance and/or productivity, including 49% who reported much to very much improvement. The amount of improvement reported across work attendance and productivity underscores the practical impact of sustained symptom relief from 60-day PNS. Given that chronic LBP is a major contributor to work absenteeism and reduced productivity, these findings illustrate how durable benefits from 60‑day PNS may support restoration of work participation, which is often a key outcome for patients and employers alike [33, 34].
Taken together, results from the present study and prior prospective studies suggest durable, long-term reductions in pain leading to improvements in other domains of patient health may be achieved following percutaneous 60-day PNS [18–21, 35]. Theorized mechanistic frameworks propose how 60-day PNS may generate focal proprioceptive neural input through targeted medial branch nerve stimulation and modulate central pain processing to enable durable improvements in chronic axial LBP that extend beyond the treatment period [36]. Given the often heterogeneous nature of chronic LBP [37], consistency of the long-term improvements seen in the present study across several different prevalent causes of chronic LBP (e.g., spondylosis/facet arthropathy, degenerative disc disease, stenosis) lends support to the concept of a treatment effect that is not specific to a single pain generator.
Limitations
A key consideration of this study is that the analysis focused on patients who reported at least 50% pain relief at the end of the 60‑day PNS treatment period. Accordingly, these findings describe the long-term durability and subsequent treatment patterns among individuals who demonstrated an initial response to 60-day PNS, which are a subset of outcomes across the full spectrum of treated patients. This focus reflects a clinically relevant question, namely, how outcomes evolve over time for patients who respond during the treatment period, and aligns with the study’s objective of characterizing the durability of benefit in 60-day PNS responders following EOT in real-world practice. This analysis relied on patient‑reported follow‑up months to years post-treatment without a concurrent control group; therefore, the findings characterize durability of benefit and subsequent treatment trajectories among initial responders but do not isolate the effects of 60‑day PNS from natural symptom variation or nonspecific treatment effects. By design, the study focused on patients who achieved clinically meaningful relief at the end of treatment and on those who completed long‑term follow‑up, which limits generalizability to the full treated population but provides clinically relevant, real‑world insight into the potential for sustained benefit and intervention avoidance among responders in routine practice. While changes in pain medication use and progression to subsequent interventional therapies were assessed, other noninterventional treatments and self‑management strategies during follow‑up were not comprehensively characterized and may have influenced patient‑reported outcomes over time.
As a cross-sectional follow-up survey focused on long-term durability and subsequent treatments, this study did not systematically collect or adjudicate safety outcomes; however, the safety profile of percutaneous 60-day PNS has been well characterized in prior prospective randomized trials and real-world studies [29].
The survey completion rate of 45% is consistent with long-term, remote patient‑reported outcome follow‑up conducted months to years after treatment, when changes in contact information and engagement commonly limit participation [38–41]. The resulting cohort of 602 survey participants represents a substantial sample for describing long‑term durability across extended follow-up periods. Although the experiences of survey nonrespondents were not captured in the results, the inclusion of a range of long-term clinical trajectories in the study outcomes, including participants reporting durable improvements and intervention avoidance as well as those who had waning benefit or progression to subsequent interventions, supports interpretation of the findings as reflective of diverse patient‑reported experiences in routine clinical practice. Interpretation of the results is further supported by the use of validated patient-reported outcome measures collected through a standardized web-based survey platform, as well as alignment of observed outcomes with findings from prior prospective and real-world studies of 60-day PNS [18–20, 22, 35, 42].
Conclusions
These findings suggest that percutaneous 60‑day PNS targeting the lumbar medial branch nerves can provide durable, multi-domain benefit for individuals with chronic axial LBP, with improvements sustained for up to 5+ years after treatment. Most participants who responded to 60-day PNS reported long‑term reductions in pain that led to improvements in other health domains and avoidance of subsequent interventions such as RFA, permanent neurostimulation implantation, and low back surgery. Consistent with other published prospective studies, including an RCT of 60-day medial branch nerve PNS in LBP, the present findings support the use of 60‑day PNS as a short-term minimally invasive treatment option that can provide long‑lasting clinical benefit, with many patients reporting avoidance of subsequent interventional and surgical treatments in long-term follow-up.
Supplementary Information
Below is the link to the electronic supplementary material.
Acknowledgements
The authors thank the study participants and the Patient Support and Clinical Affairs teams at SPR for their significant contributions during the conduct of this study, including Aaron Thornton, Lauren Easley, Rosemary Zang, Joey Wellman, Regina Bellian, Jianna Shifris, Candice Malensek, Maria Popianos, Autum Gruber, and Jacqui Lingler.
Author Contributions
Samir J. Sheth, Denise D. Lester, Jaudat Mahmood, Sarah E. Trampota, G. Lawson Smith, and Raheleh Rahimi Darabad–data analysis and interpretation, drafting the manuscript, review and revision of final version of the manuscript; Brandon D. Swan, Meredith J. McGee, and Joseph W. Boggs–study conception and design, data collection, analysis and interpretation, drafting the manuscript, review and revision of final version of the manuscript.
Funding
Sponsorship for this study and journal’s Rapid Service Fee were funded by SPR (Cleveland, OH, USA).
Data Availability
The datasets generated during and/or analyzed during the current study may be made available on reasonable request to the corresponding author or the study sponsor.
Declarations
Conflict of Interest
Denise D. Lester has research sponsored by SPR. Samir J. Sheth, Jaudat Mahmood, Sarah E. Trampota, G. Lawson Smith, and Raheleh Rahimi Darabad are consultants for SPR. Brandon D. Swan, Meredith J. McGee, and Joseph W. Boggs are employees of, named on patents assigned to, and hold stock or stock options in SPR.
Ethical Approval
The study was approved by the WIRB-Copernicus Group Institutional Review Board (WCG-IRB, #20242073) with a waiver of documentation of informed consent. The survey included a consent agreement that acknowledged the use of de-identified survey data for research purposes. The study was performed in accordance with relevant portions of the Declaration of Helsinki.
Footnotes
Prior Presentation: Preliminary results from this study were previously presented in abstracts and presentations at the American Society of Regional Anesthesia and Pain Medicine (ASRA Pain Medicine) 24th Annual Pain Medicine Meeting (November 13–15, 2025, Austin, TX, USA), and the 2026 North American Neuromodulation Society (NANS) Annual Meeting (January 21–25, 2026, Las Vegas, NV, USA).
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The datasets generated during and/or analyzed during the current study may be made available on reasonable request to the corresponding author or the study sponsor.