Open Access

Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study

  • Brian M. Ilfeld1Email author,
  • Christopher A. Gilmore2, 3, 4,
  • Stuart A. Grant5,
  • Michael P. Bolognesi6,
  • Daniel J. Del Gaizo7,
  • Amorn Wongsarnpigoon8 and
  • Joseph W. Boggs8
Journal of Orthopaedic Surgery and Research201712:4

https://doi.org/10.1186/s13018-016-0506-7

Received: 16 June 2016

Accepted: 19 December 2016

Published: 13 January 2017

Abstract

Background

Peripheral nerve stimulation has been used for decades to treat chronic pain but has not been used for postoperative analgesia due to multiple limitations, beginning with invasive electrode placement. With the development of small-diameter/gauge leads enabling percutaneous insertion, ultrasound guidance for accurate introduction, and stimulators small enough to be adhered to the skin, neurostimulation may now be provided in a similar manner to continuous peripheral nerve blocks. Here, we report on the use of ultrasound-guided percutaneous peripheral nerve stimulation to treat postoperative pain.

Materials and methods

Subjects within 60 days of a total knee arthroplasty with pain insufficiently treated with oral analgesics had a 0.2-mm-diameter electrical lead (pre-loaded into a 20 gauge needle) introduced percutaneously using ultrasound guidance with the tip located approximately 0.5–1.0 cm from the femoral nerve (a second lead was inserted approximately 1.0–3.0 cm from the sciatic nerve for posterior knee pain). An external stimulator delivered current. Endpoints were assessed before and after lead insertion and the leads subsequently removed. Due to the small sample size for this pilot/feasibility study, no statistics were applied to the data.

Results

Leads were inserted in subjects (n = 5) 8–58 days postoperatively. Percutaneous peripheral nerve stimulation decreased pain an average of 93% at rest (from a mean of 5.0 to 0.2 on a 0–10 numeric rating scale), with 4 of 5 subjects experiencing complete resolution of pain. During passive and active knee motion pain decreased an average of 27 and 30%, respectively. Neither maximum passive nor active knee range-of-motion was consistently affected.

Conclusions

Ultrasound-guided percutaneous peripheral nerve stimulation may be a practical modality for the treatment of postoperative pain following orthopedic surgical procedures, and further investigation appears warranted.

Keywords

Ultrasound-guided analgesiaPeripheral nerve stimulationPostoperative analgesiaAcute painNeuromodulationNeurostimulationUltrasound-guided percutaneous peripheral nerve stimulationOrthopedic surgeryTotal knee arthroplastyTotal knee replacement

Background

Total knee arthroplasty often results in moderate-to-severe pain that is frequently treated with opioids, themselves correlated with unwelcome side effects such as sedation, nausea, vomiting, respiratory depression, and abuse [1]. Other analgesic techniques such as continuous peripheral nerve blocks have their own limitations as they induce quadriceps weakness and are associated with an increased risk of falling [2]; duration limitations because of the risk of infection [3]; and, for outpatients, the encumbrance of carrying the local anesthetic reservoir and portable infusion pump [4]. An alternative analgesic modality—peripheral nerve stimulation—may deliver post-surgical pain control without the limitations of currently available analgesic techniques.

Peripheral nerve stimulation was initially described to treat pain over 2,000 years ago with the use of the electrical charge generated by Torpedo Fish [5]. Many hypotheses have been proposed to explain the analgesic effects of stimulation [6], but Melzack and Wall’s “gate control theory” is the most common and accepted theory [7]. In 1967, Melzack and Wall described how large-diameter myelinated afferent peripheral nerve fibers were activated by electrical current which, in turn, impeded pain signal conduction (the “gate”) within the spinal cord, to the central nervous system from small-diameter pain fibers [7, 8]. Soon thereafter, Wall and Sweet hypothesized that stimulating primary afferent neurons could produce analgesia [9]. Subsequently, off-label use of commercially available stimulators was described to deliver nerve stimulation to peripheral nerves [10]. In the past 40 years, surgically implanted peripheral nerve and spinal cord stimulators have been validated and thoroughly investigated in managing chronic pain [11, 12].

However, using neurostimulation to treat surgically induced pain has been dramatically restricted by the invasive nature of the available electrical leads that required a surgical incision to both insert and remove the multiple electrodes oriented in close proximity to the peripheral nerve [13]. In addition, the potential for nerve damage was not insignificant, and approximately one-quarter of reported implants resulted in lead migration or failure, necessitating surgical revision [10, 1421]. Finally, fibrous capsule formation adherent to the target nerve frequently led to difficult lead removal [21]. Transcutaneous electrical nerve stimulation—involving the use of large skin electrodes—circumvents these limitations [22, 23]; but, skin pain fiber activation limits the amount of tolerated current, creating an unacceptably low “ceiling” effect [24].

To facilitate the application of peripheral nerve stimulation in treating pain resulting from surgical procedures such as total knee arthroplasty, an analgesic technique should optimally be administered without the requirement of an open surgical incision for either insertion or removal. This may be accomplished with the use of very small gauge electrical leads that allow the relatively rapid insertion via a percutaneously placed needle [25, 26]. Using ultrasound guidance to guide the insertion needle, a lead may be consistently introduced 0.5–3.0 cm from a peripheral nerve utilizing the same general landmarks and approach as for perineural nerve block administration [27, 28]. Ultrasound-guided percutaneous peripheral nerve stimulation was first reported in situ by Huntoon in 2009 using an epidural neurostimulation electrode for the treatment of chronic neuropathic pain [29]. Although related methods were later described for other chronic pain conditions [3032], it has yet to be applied to a post-surgical pain state. We now report, to our knowledge, the first use of ultrasound-guided percutaneous peripheral nerve stimulation to treat post-surgical pain.

Methods

Consent to publish

This prospective feasibility study was conducted within the ethical guidelines outlined in the Declaration of Helsinki and followed Good Clinical Practice. Approval and oversight were provided by two Institutional Review Boards (Western IRB, Puyallup, WA; and Duke University Health System IRB, Durham, NC). An Investigational Device Exemption was granted for the use of these investigational devices by the US Food and Drug Administration (FDA), and written, informed consent was obtained from all subjects. The protocol was not registered as this was not a randomized, controlled trial.

We enrolled a convenience sample of adult subjects (21 years and older) with surgically related joint pain (≥3 on an 11-point numerical rating scale of the Brief Pain Inventory Short Form, Question 3: “Pain at its worst in the last 24 h”) uncontrolled with oral analgesics within 60 days following primary, unilateral, total (e.g., tricompartment) knee arthroplasty. Key exclusion criteria included the presence of implanted cardiac or deep brain stimulators, ongoing infections of the affected limb or other factors that increase the risk of infection, increased risk of bleeding (e.g., bleeding disorder), confounding pain conditions unrelated to the clinical indication for the knee arthroplasty (e.g., fibromyalgia), and nerve damage to the affected limb.

Materials

The investigational stimulation system used in the present study includes components (e.g., lead, stimulator) of a stimulation system that recently received FDA 510(k) clearance for the treatment of chronic and acute pain, including post-surgical and post-traumatic pain. Electrical stimulation was delivered through a helically coiled monopolar insulated electrical lead (MicroLead™, SPR Therapeutics, Cleveland, OH), which was pre-loaded in a 12.5 cm, 20 gauge introducer needle (Fig. 1). The lead was connected to a battery-powered electrical stimulator that was connected to the body via a surface return electrode (SPR Therapeutics, Cleveland, OH). To deliver test stimulation prior to lead placement, a 7.5 cm, 25 gauge or 12.5 cm, 24 gauge monopolar needle electrode (Test Needle, SPR Therapeutics, Cleveland, OH) was inserted. To guide placement of the lead and needle electrode, ultrasound imaging was used (M-Turbo, SonoSite, Bothell, WA; Flex Focus 400 exp, BK Medical, Peabody, MA) along with a linear array transducer (HFL38x 13–6 MHz 38 mm, SonoSite, Bothell, WA; Type 8870 18–6 MHz 60 mm, BK Medical, Peabody, MA) or curved array transducer (C60x 5–2 MHz 60 mm SonoSite, Bothell, WA; Type 8820e, 6–2 MHz 200 mm, BK Medical, Peabody, MA) to target femoral and sciatic nerves, respectively, within a sterile sleeve.
Fig. 1

A 12.5 cm, 20 g needle with a pre-loaded helically coiled monopolar-insulated electrical lead (MicroLead, SPR Therapeutics, LLC, Cleveland, OH; illustration used with permission from Brian M. Ilfeld, MD, MS)

Lead placement

The anatomic lead location was determined by the origination of pain: anterior knee pain was treated with a femoral lead, and posterior knee pain received a sciatic lead. Subjects were positioned either supine or in the lateral decubitus position for femoral and sciatic insertions, respectively. Subjects had their ipsilateral limb prepared with chlorhexidine gluconate/isopropyl alcohol solution and sterile drapes at the level of the inguinal crease or over the gluteus maximus muscle for femoral and sciatic insertions, respectively. Nerves were imaged using ultrasound in a transverse cross-sectional (short axis) view at the inguinal crease for femoral leads and between the ischial tuberosity and greater trochanter for sciatic leads (Fig. 2). A local anesthetic skin wheal was raised lateral to the transducer, and no sedation was utilized.
Fig. 2

Ultrasound image of a femoral lead insertion

To deliver test stimulation prior to lead placement, the monopolar needle electrode was inserted within the ultrasound plane and positioned approximately 0.5–1.0 cm from the femoral and 1.0–3.0 cm from the sciatic nerves. The electrical stimulator was used to deliver test stimulation (100 Hz, 15–200 μsec, 0.2–20 mA) to verify that comfortable sensations within the regions of pain could be induced without discomfort or evoking muscle contractions. If local cutaneous or subcutaneous discomfort was reported—indicating too superficial electrode placement—the needle electrode was advanced until resolution of the undesired sensations. If muscle contractions and/or discomfort distal to the lead insertion site were induced, the current intensity was reduced and/or the needle electrode was redirected until the contractions resolved.

Following a successful test (comfortable sensations and/or pain relief within the regions of pain without discomfort or muscle contractions), the monopolar needle electrode was withdrawn and replaced with the lead introducer needle (Fig. 1) using the same skin entry point and ultrasound approach. The final needle tip location was in the same location as the monopolar needle electrode (i.e., approximately 0.5–3.0 cm from the nerve). The needle was then withdrawn over the pre-loaded helically coiled electrical lead, the lead attached to a stimulator, and the stimulator subsequently attached to a surface return electrode (Fig. 3). Comfortable sensations over the regions of pain without muscle contractions confirmed accurate lead placement.
Fig. 3

A stimulator attached to the surface return electrode (SPR Therapeutics, LLC, Cleveland, OH; figure used with permission from Brian M. Ilfeld, MD, MS)

A short portion of the lead outside the body was formed into a loop and affixed to the skin at the point of exit using an occlusive dressing (Fig. 4). For subjects with pain in the posterior aspect of the knee, a second lead was inserted between approximately 0.5–3.0 cm from the sciatic nerve between the greater trochanter and ischial tuberosity, using the technique described for the femoral lead. Following the measurement of the endpoints, the occlusive dressing was removed and gentle traction applied to the lead for extraction. A small sterile bandage was applied at the lead exit point.
Fig. 4

An electrical lead connected to a portable stimulator (SPR Therapeutics, LLC, Cleveland, OH; illustration used with permission from Brian M. Ilfeld, MD, MS)

Outcome measures

Pain “right now” was evaluated first at rest and subsequently with passive and active knee motion using a Numeric Rating Scale of 0–10, with 0 and 10 equivalent to no pain and the worst imaginable pain, respectively (Question 6 of the Brief Pain Inventory, Short Form). Endpoints were evaluated immediately prior to lead insertion(s) and during the delivery of current. Passive and active knee range-of-motion was measured using a standard goniometer and included the number of degrees between the maximum flexion and extension measurements.

Safety

Subjects received a telephone call 24 to 48 h after testing to evaluate the safety of the lead exit site. Also, subjects were instructed to contact the investigators for any device- or procedure-related adverse events after testing.

Results

Five subjects were enrolled meeting all inclusion/exclusion criteria (Table 1). Leads were inserted without difficulty in all subjects; and stimulation produced comfortable sensations in the thigh/knee areas without discomfort or muscle contractions (Table 2). Percutaneous peripheral nerve stimulation produced immediate analgesia, decreasing pain an average of 93% at rest (mean NRS from 5.0 to 0.2) with 4 of 5 subjects experiencing complete resolution of pain (Table 3). In addition, pain during passive and active knee motion was reduced to 27 and 30%, respectively (Table 4). Neither maximum passive nor active knee range-of-motion was consistently affected (Table 5).
Table 1

Subject characteristics

Subject

Days since surgery

Diagnosis

Fixation method

Age (years)

Sex

BMI (kg/m2)

Leg

A

8

Osteoarthritis

Cement

48

Male

30

Left

B

9

Osteoarthritis

Cement

56

Female

26

Left

C

13

Osteoarthritis

Cement

73

Female

36

Left

D

41

Osteoarthritis

Unknown

66

Male

34

Left

E

58

Osteoarthritis

Unknown

61

Female

51

Left

Mean

26

  

61

 

35

 

BMI body mass index

Table 2

Procedure-related pain and stimulation parameters

  

Procedure-related pain

Stimulation parameters

Subject

Catheter location

(NRS)

Minimum sensation

Maximum tolerable

Optimal settings

   

(μs)

(mA)

(μs)

(mA)

(μs)

(mA)

(Hz)

A

femoral

2

15

6

15

10

15

9

100

sciatic

18

20

18

20

18

20

100

B

femoral

0

15

1

17

20

15

20

100

C

femoral

4

15

10

22

20

15

18

100

sciatic

15

20

200

20

50

20

100

D

femoral

2

15

5

26

20

19

20

100

E

femoral

1

15

1

15

5

15

5

100

Mean

1.8

15

9

45

16

21

16

100

NRS numeric rating scale (0–10)

Table 3

Pain at baseline and during percutaneous peripheral nerve stimulation with electric current

Subject

Days since surgery

At rest

Stimulation

% Change

Off

On

 

A

8

3

1

67%

B

9

3

0

100%

C

13

7

0

100%

D

41

5

0

100%

E

58

7

0

100%

Mean

26

5.0

0.2

93%

Pain evaluated using a numeric rating scale (0–10)

Table 4

Pain at baseline and during percutaneous peripheral nerve stimulation with electric current

Subject

Days since surgery

During passive range-of-motion

During active range-of-motion

  

Stimulation

% Change

Stimulation

% Change

  

Off

On

 

Off

On

 

A

8

5

5

0%

5

5

0%

B

9

5

2

60%

6

4

33%

C

13

7

5

29%

6

4

33%

D

41

9

8

11%

9

6

33%

E

58

6

3

50%

6

4

33%

Mean

26

6.4

4.6

30%

6.4

4.6

27%

Pain evaluated using a numeric rating scale (0–10)

Table 5

Range-of-motion at baseline and during percutaneous peripheral nerve stimulation with electric current

 

Passive range-of-motion

Active range-of-motion

 

Stimulation

Change

Stimulation

Change

Subject

Off

On

 

Off

On

 

A

61

60

−1

57

53

−4

B

21

39

18

10

54

44

C

63

70

7

75

61

−14

D

111

116

5

100

110

10

E

88

80

−8

87

88

1

Mean

69

73

4

66

73

7

Active and passive knee range-of-motion was measured using a standard goniometer and included the number of degrees between the maximum flexion and extension measurements

All leads were removed without difficulty approximately 1–2 h after the start of testing. There were no device-related adverse events.

Discussion

This prospective feasibility case series suggests that ultrasound-guided percutaneous peripheral nerve stimulation may be applicable to pain following total knee arthroplasty. The relatively recent convergence of five advances may now allow the wide application of this modality to treat post-surgical pain: (1) the recent propagation of ultrasound machines available to practitioners for use in regional analgesia; (2) the current pervasiveness of anesthesiologists trained in ultrasound-guided regional anesthesia; (3) an insulated electrical lead specially developed for percutaneous insertion and extended use adjacent to peripheral nerves that enables selective activation of pain-relieving fibers when inserted remote (approximately 0.5–3.0 cm) from the target nerve; (4) a novel stimulator that may be adhered directly to the skin due to its small footprint and slim design; and (5) the recent FDA 510(k) clearance of this percutaneous peripheral nerve stimulation system for the treatment of chronic pain and acute pain, including post-surgical and post-traumatic pain.

The novel electrical leads used in this investigation were comprised of a small-diameter open helical coil (0.2 mm wire diameter and 0.6 mm overall coil diameter) wound from a fluoropolymer insulated 7-strand, type 316L stainless steel wire with a single terminal anchor at the tip (Fig. 5). The lead was specifically designed to provide multiple advantages that increase the applicability of nerve stimulation to the management of post-surgical pain. Percutaneous insertion with a 20 g needle is possible due to the relatively small coil diameter (Fig. 1), and removal may be achieved simply with continuous traction. The helical shape theoretically decreases the incidence of fracture and migration, as well as lowering the risk of infection to less than 0.1% for up to 60 days [33]. The minimal infection risk and investigational device exemption (IDE) from the US FDA for use up to 60 days in clinical investigations raises the possibility of providing post-surgical analgesia that outlasts the pain resulting from not only total knee arthroplasty but the overwhelming majority of orthopedic procedures. It is for this reason that we included subjects who were within 60 days of surgery for the current investigation.
Fig. 5

A small-diameter (0.2 mm) open-coiled, helical electrical lead with an anchoring wire (MicroLead, SPR Therapeutics, LLC, Cleveland, OH; figure used with permission from Brian M. Ilfeld, MD, MS)

The single coiled monopolar lead enables a stimulation paradigm that is intended to provide pain relief while minimizing muscle contractions and discomfort from stimulation. The challenge with peripheral nerve stimulation for the treatment of pain has been to activate selectively the pain-relieving (large-diameter myelinated) fibers within a nerve trunk while avoiding activation of smaller diameter (alpha motoneurons, or types III and IV) fibers. This “selective activation” of large over small diameter fibers improves as pulse duration decreases [34] and the distance between the electrode and nerve increases [35]. Compared to conventional peripheral nerve stimulation that uses multi-electrode leads placed close to the nerve (commonly ≤0.2 cm) and wide pulse durations (90–500 μs), the stimulation paradigm in the present study utilized remote lead placement (approximately 0.5–3.0 cm from the nerve) and narrow pulse durations (15–50 μs). Such remote lead placement is enabled by the ability of the single, coiled monopolar lead to resist migration due to its coiled structure and terminal anchor at the electrode (Fig. 6).
Fig. 6

The therapeutic window and the ability to preferentially activate the targeted large nerve fibers—without activating non-targeted pain or motor neurons—increases as the distance between the electrode and the nerve increases (illustration used with permission from Brian M. Ilfeld, MD, MS)

In addition, the positive results of the present study are unlikely to be due to peripheral nerve field stimulation, where electrodes are placed subcutaneously near the regions of pain to activate adjacent nerve fibers to generate sensations locally to relieve pain. In contrast, the present technique directly stimulated peripheral nerves proximal to the surgical wound to produce sensations and analgesia distal to the leads within the nerve distributions.

Percutaneous peripheral nerve stimulation produced immediate reductions in pain that compare favorably to existing treatments for postoperative pain. Pain at rest was completely relieved in 4 of 5 subjects (overall average relief = 93%), and pain during passive and active flexion was decreased 27 and 30%, respectively. Although one subject did not achieve complete relief of pain at rest with stimulation on (pain = 1) compared to stimulation off (pain = 3), adjustment of the lead location and/or stimulation parameters may have enabled this subject to achieve complete pain relief. With this small feasibility study, we can only speculate on the degree of pain control provided with percutaneous peripheral nerve stimulation relative to single injection and continuous peripheral nerve blocks [4]. However, it is notable that adductor canal blocks reduced pain to a similar degree following total knee arthroplasty, albeit immediately following surgery [36, 37].

Ultrasound-guided percutaneous peripheral nerve stimulation has several important limitations. Small lead fragments, typically less than 0.1 mm3 in volume (less than a tenth of the volume of a common skin staple) and 0.8 mg in weight, may be retained upon withdrawal of the lead at the end of the therapy period. MRI scanning may still be performed on a patient with a retained fragment since the retained fragments are MR conditional using common scanning conditions at 1.5 Tesla [38]. Also, no lead fractures have been reported within the body during therapy and retained fragments have not produced complications when left in situ and occur in less than 8% of cases (20 of 267) when used for the treatment of pain [24, 30, 31, 3946].

Furthermore, the subjects of this feasibility study underwent treatment 8–58 days following surgery, and the quality of pain control and impact on supplemental analgesic consumption provided within the first postoperative week remains unknown. Lastly, the subjects of this pilot study underwent stimulation for less than 1 h, while the desirable duration of treatment following total knee arthroplasty would be far longer.

How practical ultrasound-guided percutaneous peripheral nerve stimulation is following total knee arthroplasty as an alternative to opiates and other analgesic techniques will be determined with further research. Ongoing studies are underway with the goal of evaluating safety (e.g., ability to reduce risks of falls relative to existing therapies), efficacy (including during the first postoperative week as well as after the end of stimulation therapy), the potential placebo effect, and the value of the therapy relative to its costs. However, the data provided by the current feasibility study suggest that there is immense potential for making a historic advancement in the treatment of post-surgical pain.

Conclusions

This prospective feasibility case series suggests that ultrasound-guided percutaneous peripheral nerve stimulation may be applicable to pain following total knee arthroplasty and possibly other orthopedic surgical procedures. If subsequent studies demonstrate a favorable risk-benefit ratio, the modality has the possibility to entirely transform post-surgical pain control as it has been performed administering local anesthetic for over 100 years [47].

Notes

Abbreviations

cm: 

Centimeters

Fig: 

Figure

g: 

Gauge

Hz: 

Hertz

mA: 

Milliamps

mm: 

Millimeters

NRS: 

Numeric rating scale

™: 

Trademark

μsec: 

Microsections

Declarations

Acknowledgements

The authors appreciate the invaluable assistance of Jamie Southern (Center for Clinical Research, Winston-Salem, NC) and Jhoanna Aquino (Duke University, Durham, NC), without whom, this study would not have been possible. In addition, the authors thank Haley Chung for her rendering of Figs. 4 and 6.

Funding

Funding for this project provided by the National Institute on Aging (1R44AG052196-01). In addition, SPR Therapeutics (Cleveland, OH) provided funding and the peripheral nerve electrical leads and stimulators used in this investigation. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the funding entities.

Availability of data and materials

Not applicable (no additional data collected beyond what is included in this report).

Author contributions

BI helped to analyze and interpret the data, authored the original manuscript, supervised the manuscript revisions, and submitted the manuscript for review. CG helped conduct the study and revise the manuscript. SG helped conduct the study and revise the manuscript. MB helped conduct the study and revise the manuscript. DDG helped conduct the study and revise the manuscript. AW helped to design/develop the protocol, conduct the study, and revise the manuscript. JB helped to design/develop the protocol, conduct the study, and revise the manuscript. All authors read and approved the final manuscript.

Competing interests

SPR Therapeutics, LLC (Cleveland, OH) provided funding and the peripheral nerve electrical leads and stimulators used in this investigation.

Brian Ilfeld: Dr. Ilfeld’s institution has received funding for his research from SPR Therapeutics (for studies other than the current investigation), Baxter Healthcare, Smiths Medical, Summit Medical, Teleflex Medical, Myoscience, and Pacira Pharmaceuticals. In addition, Dr. Ilfeld has also previously acted as a consultant to Pacira Pharmaceuticals.

Christopher Gilmore: Dr. Gilmore’s institution has received funding for his research from SPR Therapeutics and Dr. Gilmore has acted as a consultant for SPR Therapeutics.

Stuart Grant: Dr. Grant’s institution has received funding for his research from SPR Therapeutics, Cara Therapeutics, and Durrect. Dr. Grant also acts as a consultant to BBraun Medical.

Michael Bolognesi: Dr. Bolognesi’s institution has received funding for his research from Zimmer, Biomet, Depuy Synthes, and Exactech. In addition, Dr. Bolognesi is a consultant for Zimmer, Biomet, and Total Joint Orthopedics and receives royalties from Zimmer and Biomet. Lastly, Dr. Bolognesi holds stock or stock options in Total Joint Orthopedics and Amedica.

Daniel Del Gaizo: Dr. Del Gaizo’s institution has received funding for his research from Zimmer and Stryker Instruments. In addition, Dr. Del Gaizo has acted as a consultant to SPR Therapeutics.

Amorn Wongsarnpigoon: Dr. Wongsarnpigoon is an employee of SPR Therapeutics.

Joseph W. Boggs: Dr. Boggs is an employee of SPR Therapeutics and owns equity in the company.

Consent for publication

Consent to publish was obtained from all participants.

Ethics approval and consent to participate

This prospective feasibility study was conducted within the ethical guidelines outlined in the Declaration of Helsinki and followed Good Clinical Practice. Approval and oversight were provided by two Institutional Review Boards (Western IRB, Puyallup, WA; and Duke University Health System IRB, Durham, NC). An Investigational Device Exemption was granted for the use of these investigational devices by the US Food and Drug Administration (FDA); and consent to participate was obtained in the form of written, informed consent from all subjects. The protocol was not registered as this was not a randomized, controlled trial.

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Authors’ Affiliations

(1)
Department of Anesthesiology, University of California San Diego
(2)
Department of Anesthesiology, Wake Forest University Baptist Medical Center
(3)
The Center for Clinical Research
(4)
Carolinas Pain Institute
(5)
Department of Anesthesiology, Duke University Medical Center
(6)
Department of Orthopedic Surgery, Duke University Medical Center
(7)
Department of Orthopedic Surgery, University of North Carolina
(8)
SPR Therapeutics, LLC

References

  1. Kharasch ED, Brunt LM. Perioperative opioids and public health. Anesthesiology. 2016;124:960–5.View ArticlePubMedGoogle Scholar
  2. Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010;111:1552–4.View ArticlePubMedPubMed CentralGoogle Scholar
  3. Capdevila X, Bringuier S, Borgeat A. Infectious risk of continuous peripheral nerve blocks. Anesthesiology. 2009;110:182–8.View ArticlePubMedGoogle Scholar
  4. Ilfeld BM. Continuous peripheral nerve blocks: a review of the published evidence. Anesth Analg. 2011;113:904–25.View ArticlePubMedGoogle Scholar
  5. Gildenberg PL. History of electrical neuromodulation for chronic pain. Pain Med. 2006;7:S7–13.View ArticleGoogle Scholar
  6. Guan Y. Spinal cord stimulation: neurophysiological and neurochemical mechanisms of action. Curr Pain Headache Rep. 2012;16:217–25.View ArticlePubMedGoogle Scholar
  7. Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965;150:971–9.View ArticlePubMedGoogle Scholar
  8. Campbell JN, Taub A. Local analgesia from percutaneous electrical stimulation. A peripheral mechanism. Arch Neurol. 1973;28:347–50.View ArticlePubMedGoogle Scholar
  9. Wall PD, Sweet WH. Temporary abolition of pain in man. Science. 1967;155:108–9.View ArticlePubMedGoogle Scholar
  10. Long DM. Electrical stimulation for relief of pain from chronic nerve injury. J Neurosurg. 1973;39:718–22.View ArticlePubMedGoogle Scholar
  11. Deer TR, Mekhail N, Provenzano D, Pope J, Krames E, Leong M, Levy RM, Abejon D, Buchser E, Burton A, Buvanendran A, Candido K, Caraway D, Cousins M, DeJongste M, Diwan S, Eldabe S, Gatzinsky K, Foreman RD, Hayek S, Kim P, Kinfe T, Kloth D, Kumar K, Rizvi S, Lad SP, Liem L, Linderoth B, Mackey S, McDowell G, McRoberts P, Poree L, Prager J, Raso L, Rauck R, Russo M, Simpson B, Slavin K, Staats P, Stanton-Hicks M, Verrills P, Wellington J, Williams K, North R, Neuromodulation Appropriateness Consensus C. The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the Neuromodulation Appropriateness Consensus Committee. Neuromodulation. 2014;17:515–50.View ArticlePubMedGoogle Scholar
  12. Deer TR, Mekhail N, Petersen E, Krames E, Staats P, Pope J, Saweris Y, Lad SP, Diwan S, Falowski S, Feler C, Slavin K, Narouze S, Merabet L, Buvanendran A, Fregni F, Wellington J, Levy RM. The appropriate use of neurostimulation: stimulation of the intracranial and extracranial space and head for chronic pain. Neuromodulation. 2014;17:551–70.View ArticlePubMedGoogle Scholar
  13. Hassenbusch SJ, Stanton-Hicks M, Schoppa D, Walsh JG, Covington EC. Long-term results of peripheral nerve stimulation for reflex sympathetic dystrophy. J Neurosurg. 1996;84:415–23.View ArticlePubMedGoogle Scholar
  14. Nashold Jr BS, Goldner JL. Electrical stimulation of peripheral nerves for relief of intractable chronic pain. Med Instrum. 1975;9:224–5.PubMedGoogle Scholar
  15. Picaza JA, Cannon BW, Hunter SE, Boyd AS, Guma J, Maurer D. Pain suppression by peripheral nerve stimulation. Part II. Observations with implanted devices. Surg Neurol. 1975;4:115–26.PubMedGoogle Scholar
  16. Campbell JN, Long DM. Peripheral nerve stimulation in the treatment of intractable pain. J Neurosurg. 1976;45:692–9.View ArticlePubMedGoogle Scholar
  17. Long DM, Erickson D, Campbell J, North R. Electrical stimulation of the spinal cord and peripheral nerves for pain control. A 10-year experience. Appl Neurophysiol. 1981;44:207–17.PubMedGoogle Scholar
  18. Mobbs RJ, Nair S, Blum P. Peripheral nerve stimulation for the treatment of chronic pain. J Clin Neurosci. 2007;14:216–23.View ArticlePubMedGoogle Scholar
  19. Nashold Jr BS, Goldner JL, Mullen JB, Bright DS. Long-term pain control by direct peripheral-nerve stimulation. J Bone Joint Surg Am. 1982;64:1–10.View ArticlePubMedGoogle Scholar
  20. Nashold Jr BS, Mullen JB, Avery R. Peripheral nerve stimulation for pain relief using a multicontact electrode system. Technical note. J Neurosurg. 1979;51:872–3.View ArticlePubMedGoogle Scholar
  21. Picaza JA, Hunter SE, Cannon BW. Pain suppression by peripheral nerve stimulation. Chronic effects of implanted devices. Appl Neurophysiol. 1977;40:223–34.PubMedGoogle Scholar
  22. Hymes AC, Raab DE, Yonehiro EG, Nelson GD, Printy AL. Electrical surface stimulation for control of acute postoperative pain and prevention of ileus. Surg Forum. 1973;24:447–9.PubMedGoogle Scholar
  23. VanderArk GD, McGrath KA. Transcutaneous electrical stimulation in treatment of postoperative pain. Am J Surg. 1975;130:338–40.View ArticlePubMedGoogle Scholar
  24. Yu DT, Chae J, Walker ME, Hart RL, Petroski GF. Comparing stimulation-induced pain during percutaneous (intramuscular) and transcutaneous neuromuscular electric stimulation for treating shoulder subluxation in hemiplegia. Arch Phys Med Rehabil. 2001;82:756–60.View ArticlePubMedGoogle Scholar
  25. Yu DT, Chae J, Walker ME, Fang ZP. Percutaneous intramuscular neuromuscular electric stimulation for the treatment of shoulder subluxation and pain in patients with chronic hemiplegia: a pilot study. Arch Phys Med Rehabil. 2001;82:20–5.View ArticlePubMedGoogle Scholar
  26. Monti E. Peripheral nerve stimulation: a percutaneous minimally invasive approach. Neuromodulation. 2004;7:193–6.View ArticlePubMedGoogle Scholar
  27. Huntoon MA, Hoelzer BC, Burgher AH, Hurdle MF, Huntoon EA. Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes and anchoring during simulated movement: part two, upper extremity. Reg Anesth Pain Med. 2008;33:558–65.PubMedGoogle Scholar
  28. Huntoon MA, Huntoon EA, Obray JB, Lamer TJ. Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes in a cadaver model: part one, lower extremity. Reg Anesth Pain Med. 2008;33:551–7.PubMedGoogle Scholar
  29. Huntoon MA, Burgher AH. Ultrasound-guided permanent implantation of peripheral nerve stimulation (PNS) system for neuropathic pain of the extremities: original cases and outcomes. Pain Med. 2009;10:1369–77.View ArticlePubMedGoogle Scholar
  30. Rauck RL, Kapural L, Cohen SP, North JM, Gilmore CA, Zang RH, Boggs JW. Peripheral nerve stimulation for the treatment of postamputation pain—a case report. Pain Pract. 2012;12:649–55.View ArticlePubMedPubMed CentralGoogle Scholar
  31. Rauck RL, Cohen SP, Gilmore CA, North JM, Kapural L, Zang RH, Grill JH, Boggs JW. Treatment of post-amputation pain with peripheral nerve stimulation. Neuromodulation. 2014;17:188–97.View ArticlePubMedGoogle Scholar
  32. Weiner RL. Occipital neurostimulation for treatment of intractable headache syndromes. Acta Neurochir Suppl. 2007;97:129–33.PubMedGoogle Scholar
  33. Ilfeld BM, Gabriel RA, Saulino MF, Chae J, Peckham PH, Grant SA, Gilmore CA, Donohue MC, deBock MG, Wongsarnpigoon A, Boggs JW. Infection rate of electrical leads used for percutaneous neuromuscular stimulation of the peripheral nervous system. Pain Practice. [Epub ahead of print].Google Scholar
  34. Gorman PH, Mortimer JT. The effect of stimulus parameters on the recruitment characteristics of direct nerve stimulation. IEEE Trans Biomed Eng. 1983;30:407–14.View ArticlePubMedGoogle Scholar
  35. Grill WM, Mortimer JT. Stimulus waveforms for selective neural stimulation. IEEE Trans Biomed Eng. 1995;14:375–85.Google Scholar
  36. Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012;56:1013–9.View ArticlePubMedGoogle Scholar
  37. Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014;9:e111951.View ArticlePubMedPubMed CentralGoogle Scholar
  38. Shellock FG. MRI safety and neuromodulation systems, neuromodulation. Edited by Krames ES, Peckham PH, Rezai AR. Cambridge: Elsevier; 2009. p. 243–81.Google Scholar
  39. Renzenbrink GJ, IJzerman MJ. Percutaneous neuromuscular electrical stimulation (P-NMES) for treating shoulder pain in chronic hemiplegia. Effects on shoulder pain and quality of life. Clin Rehabil. 2004;18:359–65.View ArticlePubMedGoogle Scholar
  40. Chae J, Wilson RD, Bennett ME, Lechman TE, Stager KW. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case series. Pain Pract. 2013;13:59–67.View ArticlePubMedGoogle Scholar
  41. Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP. Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. Am J Phys Med Rehabil. 2005;84:832–42.View ArticlePubMedGoogle Scholar
  42. Wilson RD, Bennett ME, Lechman TE, Stager KW, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Arch Phys Med Rehabil. 2011;92:837–40.View ArticlePubMedPubMed CentralGoogle Scholar
  43. Wilson RD, Harris MA, Bennett ME, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of shoulder pain from subacromial impingement syndrome. PM R. 2012;4:624–8.View ArticlePubMedPubMed CentralGoogle Scholar
  44. Yu DT, Chae J, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Feldstein M, Fang ZP. Intramuscular neuromuscular electric stimulation for poststroke shoulder pain: a multicenter randomized clinical trial. Arch Phys Med Rehabil. 2004;85:695–704.View ArticlePubMedGoogle Scholar
  45. Wilson RD, Gunzler DD, Bennett ME, Chae J. Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial. Am J Phys Med Rehabil. 2014;93:17–28.View ArticlePubMedPubMed CentralGoogle Scholar
  46. Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series. Neuromodulation. 2014;17:771–6. discussion 776.View ArticlePubMedPubMed CentralGoogle Scholar
  47. van Zundert A, Helmstadter A, Goerig M, Mortier E. Centennial of intravenous regional anesthesia. Bier's Block (1908–2008). Reg Anesth Pain Med. 2008;33:483–9.View ArticlePubMedGoogle Scholar

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