Is a peripheral nerve stimulator implant, specifically the Sprint system, medically necessary for a 26-year-old male with chronic low back pain due to bilateral lumbar spondylosis and lumbar root disorder, who has not achieved sufficient relief from prior treatments, including Gabapentin (Neurontin) and Lyrica (Pregabalin)?

Recommendation: Peripheral Nerve Stimulator (Sprint PNS) is NOT Medically Necessary

The Sprint PNS system should be denied for this 26-year-old patient with chronic low back pain because the evidence-based treatment algorithm has not been followed, critical prerequisite therapies have not been adequately trialed, and the available evidence for peripheral nerve stimulation in axial low back pain remains insufficient.

Critical Deficiencies in Treatment Progression

Inadequate Pharmacological Management

The patient has not completed appropriate trials of first-line neuropathic pain medications before considering any neuromodulation therapy. 1

• Gabapentin trial was inadequate: The patient discontinued due to side effects (sedation, confusion, grogginess) without documented dose optimization or adequate trial duration (requires 6-8 weeks including 2 weeks at highest tolerated dose). 1

• Pregabalin (Lyrica) was just initiated: No documentation of adequate trial duration or response. 1 Evidence shows gabapentin may actually be superior to pregabalin for radicular pain with fewer adverse events. 2

• No trial of tricyclic antidepressants: Secondary amine TCAs (nortriptyline or desipramine) are first-line medications for neuropathic pain and should be trialed before any interventional procedures. 1

• No trial of SNRIs: Duloxetine or venlafaxine should be considered as first-line options. 1

Insufficient Conservative Interventional Therapies

The patient has not exhausted appropriate injection-based therapies before considering neuromodulation.

• Radiofrequency ablation (RFA) was discussed but not performed: The clinical note indicates "would like to proceed with this in the future if pain flares severely again" and offers bilateral L4-5, L5-S1 facet RFA. 1 This should be completed before any neuromodulation consideration, as moderate evidence supports facet medial nerve ablation for 3-6 months of pain relief in facet-mediated chronic low back pain. 1

• Limited injection trials: Only bilateral L5 TFESI (50% relief for one month) and right SIJ CSI (50% relief for 3-4 weeks) have been performed. 1 The patient has not undergone the recommended bilateral L4-5, L5-S1 facet RFA that was already planned.

Inadequate Physical Therapy Documentation

There is no documentation of formal, supervised physical therapy within the required timeframe. 3, 4

• The note states only "PT in the past" without dates of service, specific interventions, duration, patient response, or therapist assessment. 3

• Guidelines require formal in-person physical therapy with a licensed physical therapist for a minimum of 6 weeks within the past year with complete documentation. 3

Missing Psychological Evaluation

No psychological evaluation or clearance is documented, which is an absolute requirement before any neuromodulation trial. 3, 4

• The American Society of Anesthesiologists explicitly requires favorable psychological evaluation and absence of untreated psychiatric comorbidity before any neurostimulation trial. 3, 4

• The patient has documented anxiety in the past medical history, but there is no evidence of psychological assessment or clearance. 3

Evidence Against Sprint PNS for This Indication

Insufficient Evidence Base

The insurance criteria correctly identify Sprint PNS as having insufficient evidence for low back pain. 5

• ASIPP guidelines (2024) provide only Level III (fair) evidence with moderate certainty for implantable peripheral nerve stimulation systems, and this applies primarily to lumbar medial branch stimulation following appropriate diagnostic blocks. 5

• Temporary PNS for 60 days has Level III (fair) evidence with moderate certainty, but this does not establish superiority over standard treatments or justify bypassing the treatment algorithm. 5

• The single prospective case series (2020) showing sustained relief after short-term Sprint PNS implant had only 9 participants, with 67% response rate at 12 months. 6 This is insufficient evidence to justify use before completing standard treatment algorithms.

Spinal Cord Stimulation Evidence Does Not Support Early Neuromodulation

Even for the more established spinal cord stimulation (which has more evidence than peripheral nerve stimulation), recent high-quality evidence shows limited benefit for axial low back pain. 7

• Cochrane review (2023) found moderate-certainty evidence that SCS probably does not improve back pain, function, or quality of life compared with placebo at 6 months. 7

• Pain improvement with SCS was only 4 points better than placebo (95% CI: 8.2 better to 0.2 worse) on a 0-100 scale. 7

• Function improvement was only 1.3 points better than placebo (95% CI: 3.9 better to 1.3 worse) on a 0-100 scale. 7

• If the more established SCS technology shows such limited benefit, the less-established Sprint PNS should not be used before completing the standard treatment algorithm.

Regulatory and Coverage Context

Sprint PNS lacks formal FDA approval for the specific indication of axial low back pain, and most devices used for peripheral nerve stimulation are approved for other indications. 8

• The lack of purpose-built hardware with specific FDA approval for this indication contributes to complications and uncertain outcomes. 8

Appropriate Treatment Algorithm for This Patient

Step 1: Complete Pharmacological Trials (Current Priority)

Continue Lyrica trial with proper documentation: 1

• Titrate to therapeutic dose (150-300 mg twice daily)
• Document 8-week trial including 2 weeks at highest tolerated dose
• Record specific pain scores, functional outcomes, and adverse effects

If Lyrica fails or is not tolerated, trial nortriptyline or desipramine: 1

• Start 10-25 mg at bedtime
• Titrate slowly to 75-100 mg daily
• Obtain screening ECG (patient is 26 years old, so age >40 requirement does not apply, but baseline ECG is prudent)
• Document 6-8 week trial

Consider duloxetine if TCAs not tolerated: 1

• 60 mg daily
• Document adequate trial duration

Step 2: Complete Planned Interventional Therapies

Proceed with bilateral L4-5, L5-S1 facet RFA as already recommended: 1

• The treating physician already identified this as appropriate next step
• Moderate evidence supports 3-6 months of pain relief for facet-mediated chronic low back pain
• Perform diagnostic medial branch blocks with double-injection technique and >80% improvement threshold before RFA

Step 3: Formal Physical Therapy Program

Document structured PT program: 3, 4

• Minimum 6 weeks with licensed physical therapist
• Record dates of service, specific interventions, patient response
• Obtain therapist assessment and recommendations

Step 4: Psychological Evaluation

Obtain formal psychological clearance: 3, 4

• Assess for untreated psychiatric comorbidities (documented anxiety history)
• Evaluate patient motivation and capability to follow treatment recommendations
• Document absence of substance use disorders
• Confirm patient can operate neurostimulation device if eventually indicated

Step 5: Only After Algorithm Completion

If all above treatments fail, then consider neuromodulation with proper patient selection: 3, 4

• Document baseline validated outcome measures (VAS, ODI)
• Ensure imaging correlates with clinical presentation
• Consider spinal cord stimulation trial (more established evidence) before peripheral nerve stimulation
• Recognize that even with proper patient selection, neuromodulation for axial low back pain has limited evidence of sustained benefit 7

Common Pitfalls to Avoid

Premature escalation to neuromodulation: The 26-year-old age and "many years" of symptoms may create pressure to "do something," but bypassing the evidence-based algorithm exposes the patient to surgical risks (infection 10-29%, lead migration 9-29%, revision surgery) without completing less invasive options. 3, 7

Inadequate medication trials due to side effects: The patient discontinued gabapentin due to side effects without proper dose optimization or trying alternative first-line medications. This is insufficient to justify neuromodulation. 1

Confusing short-term injection response with treatment failure: The patient achieved 50% relief for 1 month with TFESI and 3-4 weeks with SIJ injection. This suggests potential for benefit from the planned facet RFA, which can provide 3-6 months of relief. 1

Ignoring the planned treatment: The physician already recommended bilateral facet RFA but the patient is requesting Sprint PNS instead. The evidence-based approach is to complete the RFA first. 1