Chronic plantar fasciitis, or fasciopathy, is the most
common debilitating foot complaint, affecting approximately
10% of the population and accounting for over one million office
visits and nearly $300,000,000 per year . This condition
most commonly affects women age 40 -60 years . Risk
factors include excessive running, limited ankle dorsiflexion,
flatfoot deformity, obesity, and prolonged work-or activityrelated
weight bearing .
Plantar fasciitis is a condition characterized by degeneration
of the plantar fascia and perifascial structures with
isolated inferior heel pain, particularly with the first steps of
the day and after prolonged sitting . Diagnosis of chronic
plantar fasciitis is predicated on clinical history of tenderness
over the medial tubercle of the calcaneus (the plantar fascial
insertion site) with weight bearing of at least 3 months’ duration,
first-step pain in the morning and pain relief and pain
reproduced with manual palpation over the medial calcaneal
tubercle . Imaging techniques can be employed to aid in
diagnosis of plantar fasciitis. Plantar calcaneal heel spur is visible
on lateral foot x-ray in 38.3% of cases . Ultrasound imaging
has been demonstrated to be both sensitive and specific
for diagnosis of plantar fasciitis (Figure. 1). Ultrasound features of plantar fasciitis include plantar
fascial thickness >4mm, hypoechoic appearance of the
plantar fascia and loss of fascia edge sharpness . MRI has
also been shown to be an effective diagnostic tool in the evaluation
of plantar fasciitis .
The plantar fascia connects the medial calcaneal tuberosity
to the proximal aspect of the phalanges, plays a major
role in supporting the medial longitudinal arch, and aids
in dynamic shock absorption . The term plantar fascia is
actually a misnomer since this structure is not a facial layer,
but a tendinous aponeurosis that shares histological and mechanical
traits with tendons and ligaments . Currently the
most commonly offered treatment for chronic plantar fasciitis
is open surgical plantar fasciotomy which results in only
moderate patient success rates, extended recovery times, and
potential complications such as plantar fascial rupture, medial
longitudinal arch destabilization and altered loading patterns
. Percutaneous ultrasonic fasciotomy is a minimally invasive
ultrasound guided method of cutting and removing tendinopathic
tissue. Percutaneous ultrasonic plantar fasciotomy
has been previously described. However these procedures do
not remove the diseased tissue and the available literature reports
only small patient cohorts and limited duration of follow
The purpose of this study was to assess the safety, efficacy and
durability of ultrasound guided percutaneous ultrasonic fasciotomy
as a definitive treatment for chronic plantar fasciitis in
a relatively large patient cohort.
Materials and Methods
This is a prospective non randomized study of 100
consecutive patients who were enrolled between August 2013
and May 2014. Evaluation and treatment was performed by
one of two different interventional radiologists in a single outpatient
surgery center. All patients provided verbal consent
to allow their depersonalized clinical and imaging data to be
used in this study. This study was approved by the internal review
board of Catholic Health Institute.
Inclusion criteria included: duration of symptoms > 4
months and failure of at least one conservative treatment including
but not limited to, analgesics, activity modification, physical
therapy and arch supports. Patient sex, age, Body Mass Index
(BMI), TX1 device activation time and plantar fascia thickness
were recorded along with individual clinical features (Table 1).
The Foot and Ankle Disability Index (FADI) score
(Figure.2) was collected preprocedure, 2 weeks, 6 weeks and 6
months postprocedure. This index recognizes 5 levels of pain
from none (0) to unbearable (4) for 4 activity levels .
All statistical analysis was conducted by a professional
statistician at the University of Nebraska. Linear mixed models
were estimated using restricted maximum likelihood (REML)
in SAS PROC MIXED to investigate the overall pattern of
change that was present in the data. An initial model which
is equivalent to the multivariate repeated measures analysis
of variance (ANOVA) model was estimated using an unstructured
R matrix (i.e., each variance and covariance parameter
between the four time points was allowed to vary) as well as a
saturated means model (SAS 9.3). The model included three
covariates (i.e., age, BMI, and plantar fascia thickness) as well
as each covariant’s interaction with linear and quadratic time
trends. The final model included linear and quadratic trends
over time, age, treatment duration, interaction between linear
trend and treatment time, and interaction between the linear
trend and age.
The TX1 device (Tenex Health, Lake Forest, CA) consists
of a handheld 18G needle based probe the tip of which
when activated, oscillates at a proprietary ultrasonic frequency
specifically calibrated to cut tendinopathic tissue while having
little effect on normal tissue. Saline irrigation passes through
an outer sleeveinto the treatment field as it cools the ultrasonic
tip; a vacuum provides simultaneously aspirates and removes
the cut and debrided tissue through the needle lumen (Figure.
Local anesthetic (1% lidocaine) was administered
from the plantar surface under ultrasound guidance along the
anticipated access tract. A 3to 5mm skin incision was made
along the plantar aspect of the foot approximately 1cm distal
to the medial calcaneal tubercle. The TX1 hand piece was directed
into the pathologic portion of the plantar fascia under
direct ultrasound guidance. (Terason t3200 L15-4 MHz (Terason,
Burlington, ME) or a Phillips iU22 L12-5 MHz probe
(Philips Ultrasound Inc, Reedsville, PA) (Figure. 4).
The duration of activation was at the discretion of the
operator and ranged from 46 to185 seconds. Technical success
was defined as the ability to place and activate TX1 hand piece
into pathologic portion of the plantar fascia. A standardized
postprocedure rehabilitation program consisted of placing the
treated foot in a pneumatic cam walker boot for 2 weeks’ duration.
A physical therapy program was initiated on post op day
3 consisting of education on stretching and exercise, evaluation
for shoe inserts and gait evaluation.
Technical success, identifying and entering the lesion,
was achieved in 100% of patients. As noted Foot and Ankle
Disability Index (FADI) scores were assessed preprocedure,
2 weeks, 6 weeks, and 6 months postprocedure.Patient follow
up was 100% (100 patients) at 2 weeks, 94% (94 patients) at 6
weeks and 82% (82 patients) at 24 weeks post procedure. Average
FADI scores were 59 preprocedure, 71 at 2 weeks, 83 at 6
weeks and 90 at 24 weeks post procedures (P <0.05) (Figure.
5). At 6 months, 51 of 53 (98%) indicated they were pleased
enough with the procedure to recommend it to a friend.
TX1 hand piece activation times averaged 115 secs
(range 46 to 185). There was a correlation with longer activation
times and higher FADI scores at 24 weeks (P <0.05) (Figure.
6). Plantar fascia thickness, BMI and age did not have a
statistical correlation with outcomes.
Our study protocol stratified potential complications
as minor or major based on Society of Interventional Radiologists
consensus criteria. (www.sirweb.org; practice guidelines)
However, there was only one minor complication of a patient
who experienced moderate post procedure related pain which
resolved with a 3 day course of tramadol.No additional procedure
related complications were encountered. Specifically,
there were no post procedure infections, plantar fascia rupture,
or nerve injury.
Plantar fasciitis when diagnosed in its acute stage
(< 3months duration) has a favorable prognosis, with 80% of
patients achieving symptom resolution within 1 year if timely
institution of traditional nonsurgical treatments including
activity modification, gastrocnemius and plantar fascia-specific
stretching, anti-inflammatory medications, and/or shoe
inserts[4,11,21]. However, plantar fasciitis symptoms fail
to resolve with conservative measures in 10 to 20% of cases.
When conservative measures fail, plantar fasciitis becomes a
debilitating lifestyle limiting condition. The precise etiology of
chronic plantar fasciitis is unclear, but the chronic state is histologically
defined by collagen degeneration rather than an inflammatory
process . Conventional nonsurgical treatments
in chronic plantar fasciitis may be misdirected, while therapies
which augment local hemodynamics, thereby initiating a
regenerative tissue healing cascade, have the greatest potential
to resolve long-standing symptoms . Current surgical
treatment options have a variable success rate, are invasive and
require prolonged recovery time which is not conducive to
maintain an active patient lifestyle. Ultrasonic debridement of
tendinopathic tissue has been demonstrated at the histologic
level to remove tendinopathic debris while stimulating a normalized
physiologic tendon healing response (collagen type I,
II I, and X profile) .
The cohort described in this study demonstrates percutaneous
ultrasonic fasciotomy with the Tenex TX1 handpiece
to significantly and safely reduce symptoms of chronic
plantar fasciitis. Symptomatic relief was found to be durable
to at least 24 weeks. We are in the process of recalling this cohert
of patients to determine if the early success is maintained
long term. These results are consistent with those shown in a
small pilot study for the treatment of plantar fasciitis and plantar
fibromas [1,14]. Patel et al reported on their experience in
12 patients with recalcitrant plantar fasciitis who underwent
percutaneous ultrasonic plantar fasciotomy. They noted 11/12
of the treated patients were symptom free by 3 months .
Of interest, 4 of the 12 had failed prior surgical intervention.
Additional studies currently available in the literature have
reported on the use of percutaneous ultrasonic tenotomy/
fasciotomy inpatients with refractorytendonosis / fasciosis in
other areas of the body; primarily lateral epicondylitis, medial
epicondylitis, achilles tendon, and patellar tendon. The mean
satisfactory outcome in these patients is 88% [5,8,20]. The documented outcomes reveal an excellent safety profile with no reportable minor or major complications. This
is consistent with several reports utilizing the TX1 device for
treatment of elbow tendinopathy [1,13,18].
The high procedural success rate appears to be independent
of plantar fascial thickness, BMI or patients’ age. Currently
the optimal activation time for plantar fascial treatment
cannot be defined based on the existing clinical evidence.
However, this study suggests that longer treatment times may
result in better outcomes. This experience suggests the most
effective treatment time is between 2 and 3 minutes. Further
study is warranted in regards to length of activation time. Importantly,
additional treatment time does not appear to subject
the patient to addition risk of complications.
This study has several limitations. First, is the inherent
bias of a single arm non-randomized design. Second, a single
institution experience limits the generalizability of these
results to a more heterogenous patient and operator population.
Third, outcomes based on a patient survey scoring system
while providing numerical data is truly subjective and limited
by the patient’s interpretation their own symptoms at the time
of survey. Yet such is the current direction of the requirements
for clinical treatment studies.
In conclusion, the high prevalence and the considerable
economic burden of refractory plantar fasciitis make
this treatment attractive in several ways. The described experience
demonstratespercutaneous ultrasonic fasciotomy with
the TenexHealth TX1™ device to be safe and highly effective
in the treatment of chronic plantar fasciopathy. The results
are durable to a minimum of 6 months. The excellent safety
profile, fast recovery time, and limited resource requirement
make percutaneous ultrasonic fasciotomy an attractive and effective
therapeutic option for the treatment of chronic plantar
fasciitis. Long-term outcome studies are under way and will be
helpful to clarify late term durability and incidence of recurrence
if any. Further investigation as to the optimal procedural
end points, activation times and post procedure treatment
regimen would be beneficial.
1Barnes DE, Beckley JM, Smith J (2015) Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 1:67-73.
2Berkowitz JF, Kier R, Rudicel S (1991) Plantar fasciitis: MR imaging. Radiology 179: 665–667.
3Boabighi A, Kuhlmann JN, Luboinski J, Landjerit B (1993) Aponeuroses and superficial fascia. Mechanical and structural properties. Bull AssocAnat (Nancy) 77: 3–7.
4Davis PF, Severud E, Baxter DE (1994) Painful heel syndrome: Results of nonoperative treatment. Foot Ankle Int.15:531–535.
5Elattrache N, Morrey B (2013) Percutaneous Ultrasonic Tenotomy as a Treatment for Chronic Patellar Tendinopathy – Jumper’s Knee. Operative Techniques in Orthopaedics. 23:98-103.
6Kamineni S, Butterfield T, Sinai A (2015) Percutaneous ultrasonic debridement of tendinopathy-a pilot Achilles rabbit model. J OrthopSurg Res.10:70.
7Khan KM, Cook JL, Taunton JE, Bonar F (2000) Overuse tendinosis, not tendinitis part 1: A new paradigm for a difficult clinical problem. Phys Sportsmed. 28:38-48.
8Koh JS, Mohan PC, Howe TS, Lee Bp, Chia SL, Yang Z, et al. (2013) Fasciotomy and surgical tenotomy for recalcitrant lateral elbow tendinopathy: early clinical experience with a novel device for minimally invasive percutaneous microresection. Am J Sports Med 41: 636-644.
9Lynch DM, Goforth WP, Martin JE, Odom RD, Preece CK, Kotter MW (1998) Conservative treatment of plantar fasciitis.A prospective study. J Am Pediatr Med Assoc.88:375–380.
10Martin RL, Burdett RG, Irrgang JJ (1999) Development of the Foot and Ankle Disability Index (FADI).J Orthop Sports Phys Ther. 29: A32-33.
11Martin RL, Irrgang JJ, Conti SF (1998) Outcome study of subjects with insertional plantar fasciitis. Foot Ankle Int. 19:803–811.
12Miller L, Latt D (2015) Chronic Plantar Fasciitis is Mediated by Local Hemodynamics: Implications for Emerging Therapies. N Am J Med Sci. 7:1-5.
13Mohan PC, Koh JSB, Morrey BF, Lee BPH, Howe TS, Png MA (2015) Lateral elbow tendinopathy: correlation between ultrasound findings and clinical outcomes after percutaneous ultrasonic tenotomy. ECR Congress.
14Patel MM (2015) A novel treatment for refractory plantar fasciitis.Am J Orthop 44:107-110.
15Patel MM, Patel SM, Patel SS, Daynes J (2015) A pilot study of a novel treatment method for refractory painful plantar fibromas.Austin J Orthopade&Rheumatol.2:1014.
16Riddle DL, Pulisic M, Pidcoe P, Johnson RE (2003) Risk factors for Plantar fasciitis: A matched case-control study. J Bone Joint Surg Am. 85-A:872–877.
17Sabir N, Demirlenk S, Yagci B, Karabulut N, Cubukcu S (2005) Clinical Utility of Sonography in Diagnosing Plantar Fasciitis. J Ultrasound Med 24: 1041-1048.
18Seng C, Mohan PC, Koh SB, et al. (2016) Ultrasonic percutaneous tenotomy for recalcitrant lateral elbow tendinopathy. Am J Sports Med. 2:504-510.
19Tong KB, Furia, J (2010) Economic burden of plantar fasciitis treatment in the United States. Am J Orthop.39:227-231.
20Traister L (2014) The Effect of Percutaneous Tenotomy Using Tenex On Short Term Average Pain Scores in Refractory Tendinopathies. Annual Meeting of American Medical Society for Sports Medicine.
21Wolgin M, Cook C, Graham C, Mauldin D (1994) Conservative treatment of plantar heel pain: Long-term follow-up. Foot Ankle Int.15:97–102.
22Yi TI, Lee GE, Seo IS, Huh WS, Yoon TH, Kim BR (2011) Clinical Characteristics of the Causes of Plantar Heel Pain. Annals of Rehabilitation Medicine.35:507-513.