Archived Policies - Medicine
Peripheral Subcutaneous Field Stimulation
Peripheral subcutaneous field stimulation is considered experimental, investigational and/or unproven.
Peripheral subcutaneous field stimulation (PSFS; also called peripheral nerve field stimulation or target field stimulation) is a form of neuromodulation that is intended to treat chronic neuropathic pain. One application of PSFS that is being evaluated is occipital or craniofacial stimulation for headache/migraine, craniofacial pain, or occipital neuralgia. PSFS is also being investigated for low back pain, neck and shoulder pain, inguinal and pelvic pain, thoracic pain, abdominal pain, fibromyalgia, and postherpetic neuralgia.
Chronic, noncancer pain is responsible for a high burden of illness. Common types of chronic pain are lumbar and cervical back pain, chronic headaches, and abdominal pain. All of these conditions can be challenging to treat. Medications are typically the first-line treatment for chronic pain, and several classes of medications are available. These include analgesics (opioid and nonopioid), antidepressants, anticonvulsants, and muscle relaxants. There also are a variety of nonpharmacologic treatments, including physical therapy, exercise, cognitive-behavioral interventions, acupuncture, chiropractic, and massage.
Neuromodulation is another form of nonpharmacologic therapy that is usually targeted toward patients with chronic pain that is refractory to other modalities. Some forms of neuromodulation, such as transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS), are established methods of chronic pain treatment. Peripheral nerve stimulation, which involves placement of an electrical stimulator on a peripheral nerve, is also used for neuropathic pain originating from peripheral nerves.
Peripheral Subcutaneous Field Stimulation
PSFS is a modification of peripheral nerve stimulation. In PSFS, leads are placed subcutaneously within the area of maximal pain. The objective of PSFS is to stimulate the region of affected nerves, cutaneous afferents, or the dermatomal distribution of the nerves, which then converge back on the spinal cord. Combined SCS and PSFS are also being evaluated.
Similar to SCS or peripheral nerve stimulation, permanent implantation is preceded by a percutaneous stimulation trial with at least 50% pain reduction. Currently, there is no consensus regarding the indications for PSFS. Criteria for a PSFS trial may include a clearly defined, discrete focal area of pain with a neuropathic or combined somatic/neuropathic pain component with characteristics of burning and increased sensitivity, and failure to respond to other conservative treatments including medications, psychological therapies, physical therapies, surgery, and pain management programs.
The mechanism of PSFS is unknown. Theories include an increase in endogenous endorphins and other opiate-like substances; modulation of smaller A delta and C fibers by stimulated large-diameter A beta fibers; local stimulation of nerve endings in the skin; local anti-inflammatory and membrane-depolarizing effect; or a central action via antegrade activation of A beta nerve fibers. Complications of PSFS include lead migration or breakage and infection of the lead or neurostimulator.
No devices have been approved specifically for PSFS. PSFS is an off-label use of SCS devices that have been approved by the FDA for the treatment of chronic pain
The literature on peripheral subcutaneous field stimulation (PSFS) was searched through May 31, 2015. Relevant literature includes 1 randomized, crossover study; 1 small comparative trial that evaluated combined PSFS and spinal cord stimulation (SCS); 2 large retrospective case series from outside of the United States (US); and a number of small case series.
Case series are insufficient to evaluate pain outcomes due to the variable nature of pain and the subjective nature of the outcome measures. Randomized controlled trials (RCT) with adequate blinding are needed to control for the variable natural history of pain, as well as for the expected placebo effect in research on pain treatment.
McRoberts et al. (2013) reported on a randomized, crossover trial of different types of PSFS in 44 patients with chronic back pain. This study did not include a control group or a comparison group of alternative treatment modalities. In the first phase of the study, patients rotated through 4 different levels of trial PSFS: minimal, subthreshold, low frequency, and standard stimulation. (1) Of the 30 patients who completed phase 1, 24 reported that pain was significantly reduced by at least 50% in any of the stimulation groups and were considered responders to PSFS. In phase 2, a permanent PSFS system was then placed in 23 of the responders. Patients were followed for 52 weeks during which time reported mean visual analog scale (VAS), present pain index, and total scores on the Short-Form McGill Pain Questionnaire were significantly improved from baseline at all follow-up visits (p<0.001). Because this study did not include any control group, the methodologic strength of these results is similar to that of an uncontrolled study.
In 2014, Kloimstein et al. reported on a prospective study of 118 patients treated with PSFS for chronic low back pain. (2) Before patients were implanted with the permanent PSFS system, trial stimulation was given for at least 7 days. The permanent stimulation system was implanted in 105 patients. Significant improvements occurred at 1, 3, and 6 month follow-up after implantation in average pain VAS, Oswestry Disability Questionnaire, Beck Depression Inventory, and 12-Item Short-Form Health Survey. Significant reductions in use of opioid, nonsteroidal anti-inflammatory, and anticonvulsant medications also occurred.
A prospective comparative study of combined use of SCS and PSFS in patients with low back pain was reported by Mironer et al. in 2011. (3) In the first part of the study, 20 patients with failed back surgery syndrome or spinal stenosis underwent a trial with both SCS and PSFS and selected the type of stimulation they found most efficacious (program 1: SCS alone; program 2: PSFS alone; or program 3: combined SCS and PSFS). Patients were blinded to the difference between the programs (randomized order of presentation) and were encouraged to try each program for at least 8 hours; 79% percent of patients preferred the simultaneous use of SCS and PSFS. In the second part of the study, 20 patients were implanted with SCS and PSFS electrodes and selected which program they preferred (SCS and PSFS used simultaneously, SCS as anode and PSFS as cathode, or SCS as cathode and PSFS as anode). The programs were presented in a random order, and patients were blinded to the difference between the programs. Communication between SCS and PSFS was reported to provide wider coverage of axial pain, with an overall success rate (>50% pain relief) of 90%. The most effective program was SCS as cathode and PSFS as anode.
Other large case series were identified. In 2013, Verrills et al. reported on PSFS for chronic headache conditions. (4) After a trial stimulation period, 60 patients underwent permanent implantation of the PSFS system and were followed for an average of 12.9±9.4 months (range, 3-42 months). Ten patients required revision of the implant system. Significant reductions in pain from baseline were reported (p≤0.001). Additionally, use of analgesics or prophylactic medications was reduced in 83% of patients and disability and depression improved.
Sator-Katzenschlager et al. (2010) reported a retrospective multicenter study of the use of PSFS. (5) A total of 111 patients with chronic pain were treated, including 29 patients with low back pain, 37 with failed back surgery syndrome, 15 with cervical neck pain, and 12 patients with postherpetic neuralgia. The median duration of chronic pain was 13 years and the median number of previous surgeries was 2.7. For permanent implantation of the leads, patients had to have achieved at least 50% improvement in pain on a numerical rating scale during the trial period. After permanent implantation, pain intensity decreased in 102 patients (92%). Mean pain intensity decreased from 8.2 at baseline to 4.0 at follow-up with a reduction in consumption for analgesics and antidepressants. Lead dislocation or fracture occurred in 20 patients (18%).
In 2011, Verrils et al. reported on a series of 100 patients treated with PSFS for chronic neuropathic pain. Indications included chronic pain in occipital/craniofacial (n=40), lumbosacral (n=44), thoracic (n=8), groin/pelvis (n=5), or abdominal (n=3) regions. (6) Selection criteria included a clearly defined, discrete focal area of pain with a neuropathic component or combined somatic neuropathic pain component with characteristics of burning and increased sensitivity, and failure to respond to other conservative treatments including medications, psychological therapies, physical therapies, surgery, and pain management programs. Outcomes were assessed at a mean of 8.1 months after implantation (range, 1- 23 months) with a combination of numeric pain scores, self-report questionnaires, and patient medical histories. For the entire cohort, pain decreased from 7.4 at baseline to 4.2 at follow-up. Pain scores improved by 75% or more in 34% of patients and by 50% or more in 69% of patients. Analgesic use decreased in 40% of patients after PSFS. Adverse events were reported in 14% of patients and included unpleasant sensations, lead erosions, and lead or battery migration.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov found 2 randomized studies using PSFS in combination with SCS for the treatment of chronic low back and leg pain due to failed back surgery syndrome.
• NCT01990287: Treatment of low back pain, this study has been suspended. The ClinicalTrials.gov entry was last verified in June 2015.
• NCT01776749: Treatment of low back pain in failed back pain syndrome. The status of this study is Active, not recruiting. The ClinicalTrials.gov entry was last verified in January 2015.
Practice Guidelines and Position Statements
In 2013 the National Institute for Health and Care Excellence issued guidance on PSFS. (7) The guidance indicated:
“Current evidence on the efficacy of peripheral nerve-field stimulation (PNFS) for chronic low back pain is limited in both quantity and quality, and duration of follow-up is limited. Evidence on safety is also limited and there is a risk of complications from any implanted device. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.”
Summary of Evidence
Evidence on PSFS is limited, comprising 1 small randomized, crossover study; 1 small uncontrolled study that evaluated combined PSFS and SCS; 2 large retrospective case series; and a number of small case series. The single RCT compared different methods of PSFS and did not include a control or active comparison group; therefore this study offers little evidence for efficacy beyond that of a prospective, uncontrolled study. Case series suggest that self-reported pain is reduced after treatment with PSFS. However, case series are insufficient to evaluate pain outcomes due to the variable nature of pain and the subjective nature of the outcome measures. Prospective controlled trials comparing PSFS with placebo or alternative treatment modalities are needed to determine the efficacy of this treatment for chronic pain. Therefore, PSFS is considered experimental, investigational and/or unproven.
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[Deleted 1/2017: 0282T, 0283T, 0284T, 0285T]
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1. McRoberts WP, Wolkowitz R, Meyer DJ, et al. Peripheral nerve field stimulation for the management of localized chronic intractable back pain: results from a randomized controlled study. Neuromodulation. November 2013; 16(6):565-575. PMID 23577773
2. Kloimstein H, Likar R, Kern M, et al. Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study. Neuromodulation. February 2014; 17(2):180-187. PMID 24320718
3. Mironer YE, Hutcheson JK, Satterthwaite JR, et al. Prospective, two-part study of the interaction between spinal cord stimulation and peripheral nerve field stimulation in patients with low back pain: development of a new spinal-peripheral neurostimulation method. Neuromodulation. March-April 2011; 14(2):151-154; discussion 155. PMID 21992203
4. Verrills P, Rose R, Mitchell B, et al. Peripheral Nerve Field Stimulation for Chronic Headache: 60 Cases and Long-Term Follow-Up. Neuromodulation. October 24 2013. PMID 24165152
5. Sator-Katzenschlager S, Fiala K, Kress HG, et al. Subcutaneous target stimulation (STS) in chronic noncancer pain: a nationwide retrospective study. Pain Pract. July-August 2010; 10(4):279-286. PMID 20230450
6. Verrills P, Vivian D, Mitchell B, et al. Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Pain Med. September 2011; 12(9):1395-1405. PMID 21812906
7. National Institute for Health and Care Excellence. IPG451 Peripheral nerve-field stimulation for chronic low back pain: guidance. 2013; available at www.nice.org.uk>.(IPG451). Accessed 16 June 2015.
8. Peripheral Subcutaneous Field Stimulation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (March 2015) Surgery 7.01.139.
|2/1/2017||Reviewed no changes.|
|8/1/2015||Document updated with literature review. Coverage unchanged.|
|7/1/2014||Reviewed no changes.|
|10/15/2013||New medical document. Peripheral subcutaneous field stimulation is considered experimental, investigational and unproven. (Coverage is unchanged. This topic was previously addressed on MED205.032, Percutaneous and Implanted Nerve Stimulation and Neuromodulation).|
|Title:||Effective Date:||End Date:|
|Peripheral Subcutaneous Field Stimulation||07-15-2017||06-14-2018|
|Peripheral Subcutaneous Field Stimulation||02-01-2017||07-14-2017|
|Peripheral Subcutaneous Field Stimulation||08-01-2015||01-31-2017|
|Peripheral Subcutaneous Field Stimulation||07-01-2014||07-31-2015|
|Peripheral Subcutaneous Field Stimulation||10-15-2013||06-30-2014|