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OUTLINE

1. Abstract
2.
3. Keywords
4. Abbreviations
5. Case Report
6. Methods
7. Discussion
8. Conclusions
9. Suppliers
10. References
11. Disclosure
12. Appendix. Supplementary materials

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FIGURES (4)

1.
2.
3.
4.

TABLES (5)

1. Table 1
2. Table 2
3. Table 3
4. Table 4
5. Table 5

EXTRAS (2)

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2. Supplemental Material
3. Supplemental Material

ARCHIVES OF REHABILITATION RESEARCH AND CLINICAL TRANSLATION

Available online 5 October 2024, 100374
In Press, Journal Pre-proofWhat’s this?

CASE REPORT
CRYONEUROLYSIS AND QUADRIPLEGIA: A CASE REPORT ON PAIN AND SEVERE SPASTICITY
MANAGEMENT

Author links open overlay panelLaura SCHATZ BSc 1, Samuel HERZOG 1 2, Mahdis
HASHEMI MD 1, Paul WINSTON MD FRCPC 1 3 4
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ABSTRACT

Spasticity, a common symptom following spinal cord injury, often leads to pain,
muscle contracture, and compromised daily activities. Cryoneurolysis, a
minimally invasive, drug-free procedure for the treatment of pain is now gaining
recognition for treating spasticity. It involves using an ultrasound-guided
probe to freeze and destroy overactive target nerves. The objective of this case
study was to assess the impact of cryoneurolysis on joint range of motion by
reducing spasticity and pain in a person with quadriparetic spinal cord injury.
A 52-year-old male with C4 incomplete quadriplegia presented with severe right
hip osteoarthritis, causing a severe hip flexion deformity with hip flexor
spasms, as well as spasticity in the upper limbs. Previous attempts with
exceeding maximum-dose botulinum toxin injections for the lower limb proved
insufficient to improve range of motion. Percutaneous cryoneurolysis was
performed to multiple nerves, contributing to spasticity in the upper and lower
limbs. Immediately after each procedure, the patient experienced an increased
range of motion in the upper and lower limb targeted regions. During the
patient's follow-up, he also reported improvements in performing daily
activities, such as independent showering, no falls, and a significant decrease
in muscle tone. Results were primarily maintained up to 9 months post-procedure,
when cryoneurolysis was repeated for the lower limbs only. Upon repeat
cryoneurolysis, results were re-established.
Cryoneurolysis is a non-surgical, percutaneous procedure which could be
considered for pain and spasticity management in patients with quadriplegia. It
can provide an option for improved quality of life and independence for
patients.

KEYWORDS

Spinal Cord Injuries
Nerve Block
Muscle Spasticity
Denervation
Case Report

ABBREVIATIONS

BoNT
Botulinum toxin
DNB
Diagnostic nerve block
ROM
Range of motion
SCI
Spinal cord injury
AROM
active range of motion
MAS
Modified Ashworth Scale
Spasticity, a velocity-dependent increase in tonic stretch reflexes, is a common
complication in patients with upper motor neuron lesions, including patients
with spinal cord injuries (SCI). 1,2 Spasticity directly causes pain and
distorted joint positioning, leading to difficulties with hygiene and pressure
sores. It can also lead to further complications, such as musculotendinous
retractions and joint contractures 3 Spasticity is a ubiquitous complication for
spinal cord injury patients 2 It may affect many muscle groups and lead to
decreases in independence. Cryoneurolysis is a novel, percutaneous procedure
consisting of targeted destruction of the axons of motor neurons via a freezing
cold cryoprobe.

CASE REPORT

A 52-year-old man presented with severe lower limb spasticity, as well as
spasticity affecting the wrist and hands, as a complication of C4 incomplete
quadriplegia acquired in a motor vehicle accident in 1991. There was severe
osteoarthritis in his right hip (Figure 1). The hip joint was functionally fixed
in place, in severe hip adduction and flexion. The associated pain was an
exacerbating factor in his spasticity which contributed to disruptive hip
flexion spasms and. (Figure 2a). His wrist and finger spasticity impacted
functional usage.
1. Download: Download high-res image (507KB)
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Figure 1. Hip x-ray.

1. Download: Download high-res image (670KB)
2. Download: Download full-size image

Figure 2. Lower limb range of motion.

He had a 15-year history of repeat BoNT injections at high (600 units every 3
months) doses, exceeding on-label recommendations. These were all on the right
leg, labelled as: Hamstrings 250 units, adductors 200 units, and hip flexors 150
units (all of which are considered off-label muscle groups in the lower
extremities). Treatment included 80 mg of oral baclofen, administered daily, as
well as diazepam and zopiclone for sleep disruptions due to hip flexion spasms.
Physiotherapy was ineffective in altering the range of motion. He experienced
recurrent pressure sores in the lower extremities due to shearing and flexion
caused by his spasticity and had been recommended for a right Girdlestone
excision arthroplasty as a treatment. There were many disruptions to his
independence due to the combination of these factors, including issues with
transferring, wheelchair positioning, sleep disturbance, and reduced ability to
perform activities of daily living. He had plateaued in his response to
treatment for several years. This case report aims to determine the efficacy of
cryoneurolysis as a treatment for pain and spasticity in an SCI patient with
severe orthopedic deformity and impaired hand function. The anatomy of novel
muscles not previously published for cryoneurolysis will be demonstrated.
Accompanying videos demonstrate the patient's progress and cryoneurolysis
technique (See Video 1; Video 2).

METHODS

Following the case report (CARE) guidelines, informed consent was obtained for
the procedures, and measures were taken to ensure patient confidentiality
throughout the study. Institutional research ethics board approval was not
required. In publications on cryoneurolysis, changes in range of motion are
reported using the Modified Ashworth Scale (MAS) and the Modified Tardieu Scale,
which includes the angles (X) of maximum passive ROM X(V1) about the joint and
the angle of catch with quick movement X(V3).2

CRYONEUROLYSIS

To prepare for cryoneurolysis, the skin at the injection sites was swabbed with
chlorhexidine to reduce infection risk. Local injections of 1% lidocaine were
performed to anesthetize the entry points. A 16-gauge angiocatheter was inserted
to guide the cryoprobe, enhance the echogenicity of the ultrasound, and shield
the skin from the cold cryoprobe. The probe was inserted through the catheter,
and target nerves were located using ultrasound guidance, and electrical
stimulation (less than 1 mA at 1Hz). Each lesion consisted of a freezing and
thawing cycle lasting 106 seconds. No adverse events were reported during or
directly after the treatment.

FIRST LOWER EXTREMITY PROCEDURE

The severe deformity of the right hip suggested that multiple muscles were
co-contracting simultaneously in addition to the orthopedic deformity. Potential
side effects were communicated, and consent was given to perform cryoneurolysis
using the Iovera Handheld Systema, a free-standing unit that uses liquid nitrous
oxide capsules. The severe hip adduction was addressed by targeting the
bilateral anterior and posterior divisions of the obturator nerve as described
by MacRae et al, 2023.4 Hip flexion may be caused to by multiple muscles. 5 The
rectus femoris anatomy for cryoneurolysis was described by Boissonnalt et al in
2024,6 and the addition of the underlying vastus intermedius is shown in Figure
3. The iliacus portion of the iliopsoas was only seen after treatment of the
rectus femoris, which allowed for hip extension and visualization of this muscle
under ultrasound and was treated intramuscularly. The right sartorius muscle was
later added during a repeat cryoneurolysis to help reduce the hip flexion
contracture, as it is a hip flexor. The sartorius was located on ultrasound
above the rectus femoris, adjacent to the femoral vessels (Figure 3). The knee
flexion was addressed by treating the hamstring muscle groups intramuscularly as
they flex the knee adding to the flexion movement about the hips.7 The
intramuscular sciatic nerve branches of the semimembranosus and semitendinosus
were localized 5-10 cm below the subgluteal fold. The treated muscles are listed
in Table 1.
1. Download: Download high-res image (738KB)
2. Download: Download full-size image

Figure 3. Ultrasound anatomy of implicated muscles

Table 1. Targeted sites for cryoneurolysis.

Empty CellUpper Limb CryoneurolysisLower Limb CryoneurolysisRepeat
Cryoneurolysis (Lower Limb)Sites TargetedIntramuscular branches of FDS
(bilateral)
FCR & palmaris longus (left)Peripheral nerves to rectus femoris (bilateral)
Anterior and posterior divisions of obturator nerve (bilateral)
Intramuscular branches of medial and lateral hamstrings (bilateral)†
Vastus intermedius (right)†
Iliopsoas at the hip (right)Rectus femoris (right)
Anterior and posterior divisions of obturator nerve (bilateral)
Vastus intermedius (right)
Sartorius (right)*

⁎
This muscle was added onto the protocol upon repeat cryoneurolysis of the lower
limb.
†
These muscles were added onto the protocol on three month follow-up.

RESULTS FOR LOWER EXTREMITIES

After the cryoneurolysis procedure, immediate improvements in range of motion
were demonstrated and the patient reported being “happy with the extra movement”
for bilateral knee extension (Figure 2, Table 2) and hip extension and
abduction. Improvements were also seen at 3, 6, and 9-month follow-ups,
sustained in the left leg (Table 2, 3). For hip abduction, improvements were
sustained up to 9 months, with a peak for the left and right side at 6 and 2
months, respectively. Between the three and 9-month follow-up, the abduction of
the osteoarthritic right hip gradually lessened but remained improved from
baseline. The patient's tone as measured on the Modified Ashworth Scale did not
decrease significantly, possibly due to the severe joint restrictions as well as
joint pain and pressure ulcers.

Table 2. Follow-up results for the lower limb.

Follow upLower Limb3
* •
Results sustained for inter-knee distance, left hip abduction, and bilateral
knee extension (Table 4).
* •
The patient reported tightness in the rectus femoris was significantly
reduced.

6
* •
Improvements in ROM for bilateral hip abduction.
* •
The patient reported gains in lower limb positioning, and a cessation of hip
flexor spasms (Table 4).

9
* •
Results largely maintained, left leg still able to reach full
* •
Tone reappearing bilaterally in the hips, particularly on the

Table 3. Quantitative measurements for upper and lower extremities.

Empty CellBaseline2-month follow up3-month follow up6-month follow up9-month
follow up†11-month follow-up‡Left Hip
AbductionX(V1)*10°25°25°35°25°30°X(V3)*0°5°5°10°10°0°AROM⁎⁎NoneNoneNoneNoneNoneNoneMAS⁎⁎⁎323332Right
Hip
AbductionX(V1)5°20°5°10°15°20°X(V3)0°10°-5°0°-0°AROMNoneNoneNoneNoneNoneNoneMAS333323Left
Knee Extension (with hip at
90°)X(V1)-40°--40°-35-35°-30°X(V3)-105°--105-60-75°-65°AROMNone-NoneNoneNoneNoneMAS3-3322Right
Knee Extension (with hip at
90°)X(V1)-100°--100°-65-70°-30X(V3)-105°--105°-90-90°-80AROMNone-NoneNoneNoneNoneMAS3-3333Inter-Knee
Distance15.5 cm29 cm32 cm29 cm28 cm30 cm--22 cm22 cm23 cm23 cmLeft Wrist
ExtensionX(V1)65°-90°-85°-X(V3)30°-65°-65°-AROM15°-50°-50°-MAS2-1+-1+-Right
Wrist ExtensionX(V1)85°-90°-90°-X(V3)35°-No
catch-65°-AROMNone-35°-20°-MAS2-0-1+-Box and Block TestLeft9 blocks-15
blocks---Right2 blocks (Test limited due to shoulder)-Not repeated---Hygiene
Score-32--2-

⁎
X denotes the angle. X(V1) denotes the maximal range of passion range of motion.
X(V3) denotes the angle of catch or clonus.
⁎⁎
AROM Active range of movement.
⁎⁎⁎
MAS Modified Ashworth Scale. Measured within the patient's available ROM.
†
This was also used as the baseline measure for repeat cryoneurolysis to the
lower limb.
‡
This was also the 2-month follow-up from repeat cryoneurolysis.

REPEAT LOWER EXTREMITY CRYONEUROLYSIS

At 9 months, spasms driven by the hip pain returned as the nerve regrew;
therefore, repeat cryoneurolysis was deemed necessary (Table 1). Immediately
after the repeat procedure, increases in right hip and knee ROM were
reestablished (Table 3, 4). Two months following the repeat procedure, there
were improvements seen in ROM in left and right hip abduction of 5° each, left
and right knee extension of 5° and 40°, respectively, and inter-knee distance of
2 cm (Table 3). A decrease in left hip abduction tone was also noted. The
presentation and technique for the lower extremity are found in Video 1.

Table 4. Repeat cryoneurolysis results.

Follow-upLower Limb - Repeat CryoneurolysisImmediate resultsDecreased tone and
increased ROM for the right leg re-established.2 MonthsBilateral improvements in
ROM for hip abduction, knee extension, and interknee distance (Table 4).
No difference in tone upon follow-up.
Pronounced improvement in right knee extension.

CRYONEUROLYSIS FOR UPPER EXTREMITIES

After the success of the lower extremities, focus was placed on the upper
extremities. He had received one remote injection in his hands to the flexor
digitorum superficialis (FDS) and profundus (FDP) with botulinum toxin, which
did not improve function. Upon physical examination, several targets were
identified as potential contributors to the patient's spasticity (Table 1). The
FDS, flexor carpi radialis (FCR), and palmaris longus are innervated by the
median nerve and are involved in finger and wrist flexion - actions important in
grip and fine motor control. 5
As it was crucial not to weaken the patient to avoid losing function and to
evaluate muscle contribution to spasticity, a diagnostic nerve block (DNB) using
2 cc of (1%) lidocaine was performed intramuscularly to the bilateral FDS
muscles and the left flexor pollicis longus (FPL).8 Following the DNB, the
patient reported immediate improvement in range of motion, ease of movement, and
relaxation of the fingers and hand, with no sensory disruptions. There were
still restrictions in movement at the left wrist, suggesting that these muscles
were an additional target. Cryoneurolysis was then performed at a later date to
allow the DNB to wear off (Table 1). It was noted that the left thumb relaxed
after the proximal muscles were treated and did not require treatment of the
FPL, suggesting a possible synergistic movement.

RESULTS FOR THE UPPER EXTREMITIES

After cryoneurolysis for the upper limb, at 3 months follow-up (Table 3), there
were increases of 25° and 5° for right and left passive wrist extension,
respectively, and a bilateral increase in active wrist extension of 35°. The
right hand opened up significantly enough to have a cylinder grip. There was a
bilateral decrease in tone for wrist extension, and all fingers demonstrated
improved motor control. The left fingers were able to extend fully, and
significant improvements were seen in left wrist function (Figure 4).
Improvements were maintained at 9 months post-procedure (Table 3,5). Measures
showed a mild decrease in wrist extension at 9 months, however, in comparison to
baseline a significant increase was still notable. An improvement in hygiene
score was also observed after the procedure and was found sustained at 9 months
follow-up (Table 3).9 A video of the presentation and cryoneurolysis is found in
Video 2.
1. Download: Download high-res image (290KB)
2. Download: Download full-size image

Figure 4. Wrist and Handfigure range of motion

Table 5. Follow-up results for the upper limb.

3 months
* •
Results sustained for bilateral wrist extension.
* •
The patient reported feeling “delighted” with the improvements in hand
function, specifically with wheelchair maneuvering, teeth brushing, face
cleaning, and grasping.
* •
MAS scores represented decreases in wrist flexor tone bilaterally (Table 3).
* •
Box and Block test results demonstrated an improvement in left hand function
(Table 5).
* •
The patient reported many improvements in ADLs as a result of the procedure,
such as being able to shower independently

6 Months
* •
Examining physician reported that the patient's hands felt “dramatically
better”

9 Months
* •
Patient noted functional improvements in hand/wrist function for both hands

DISCUSSION

Spasticity is present in over 80% of SCI patients and is often a major
contributor to disability, leading to restrictions in many daily activities.10
It develops gradually in the months following injury, and is often most
pronounced in lower extremity flexors.2 The first line of treatment for
spasticity in SCI patients includes both widespread and focal antispasmodic
agents (such as Baclofen and BoNT) and stretching with physiotherapy. Therapy
outcomes are inconsistent due to the presence of spasms, clonus, contracture and
osteoarthritis seen in SCI. Surgery is also used to treat associated
non-reducible deformities. Due to the widespread nature of spasticity in SCI
patients, the maximum dose of BoNT is often reached before patient goals are
met. In Canada and the United States, the maximum on-label dose of BONT is 400
units and 360 units per injection, respectively, which is significantly less
than this patient's 600 units. Furthermore, the product monograph of the
onabotulinum toxin A used does not include any lower extremity muscles above the
knee, as they are considered off-label.11 Oral baclofen is an insufficient
treatment for some patients, and there are numerous challenges associated with
treatment through intrathecal baclofen, such as pump malfunction or
catheter-related complications. 12
Cryoneurolysis disrupts the conduction of motor neurons through the targeted
application of freezing temperatures. The immediate improvements in ROM and
muscle relaxation observed post-procedure can be attributed to the precise
targeting of these key muscles and their neural innervations. The sustained
effects at 3- and 9-month follow-ups suggest that cryoneurolysis provides
immediate relief and offers a lasting reduction in spasticity. This long-term
benefit is likely due to the length of the regenerative process of the nerves,
as well as the possibility for developing a more normalized pattern of neural
activity during nerve regrowth. Cryoneurolysis may also be administered to the
intramuscular motor branches, allowing for better treatment of hand and wrist
spasticity, with immediate results and patient feedback.13 For this patient,
percutaneous cryoneurolysis was used to treat nerves or muscles which were non-
or minimally responsive to off-label BoNT. Immediate relaxation achieved through
cryoneurolysis allowed sequential access to muscles inaccessible due to severe
hip deformity.
Additionally, many persons with SCI are medically frail or have issues with
positioning which infringe upon their ability to receive more invasive
treatments.14 SCI patients with spasticity are more prone to hip osteoarthritis,
and are also poorer candidates for hip arthroplasty due to increased risks of
dislocation, component loosening, and heterotrophic ossification.15
Cryoneurolysis could provide an additional treatment option for patients who are
not candidates for hip arthroplasty or other invasive surgeries. The reductions
in spasticity through the cryoneurolysis treatment may also alleviate some of
the spasticity-associated risks of hip arthroplasty. Thus, cryoneurolysis
differs from botulinum toxin and surgical neurectomy because of the immediate
effect on an awake patient, and the minimally-invasive nature of the procedure.

STUDY LIMITATIONS

The case study research design puts an inherent limit on the generalizability of
findings. Quadriplegia is a diverse condition with varying levels of severity,
patterns of muscle involvement, and individual patient factors. This
heterogeneity means that results rely on the individualized assessment and
response to the DNB for each patient. Future studies involving larger, more
diverse cohorts as well as randomized controlled trials are necessary to
validate these results and ensure they are applicable to a broader population.

CONCLUSIONS

Percutaneous cryoneurolysis in SCI resulted in many months of improvements in
bilateral hip abduction and knee extension ROM. Retreatment at 9 months to the
legs returned the gains. Bilateral wrist extension ROM and MAS scores were
maintained in 9 months. There was a significant increase in independence and
ease for several daily activities, including tooth brushing, showering, and
wheelchair transfers. Cryoneurolysis could be an effective, long-lasting method
for managing severe spasticity in patients with SCI with minimal side-effects.

SUPPLIERS

aIovera System 190 Smart Tip; Iovera, Pacira

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There is no financial support for the preparation of this case report.

DISCLOSURE

Paul Winston has received grants, and educational funding, and has served on Ad
boards of Abbvie, Ipsen, Merz and Pacira Laura Schatz has no conflicts of
interest Mahdis Hashemi has no conflicts of interest Samuel Herzog has no
conflicts of interest CS
Video 1. Treatment of the lower extremities with cryoneurolysis.
Video 2. Treatment of the wrist and fingers with cryoneurolysis.

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