Trial Outcomes & Findings for Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device (NCT NCT01863901)

NCT ID: NCT01863901

Last Updated: 2024-01-24

Results Overview

The Modified Ashworth Scale (MAS) is 6-point scale designed to assess muscle tone and spasticity through the flexion or extension of a joint. Muscle response is graded on a scale from 0 (no increase in muscle tone) to 4 (affected parts rigid in flexion or extension). This includes a 1+ rating, which further distinguishes the types of increase in muscle tone from those described by a 1 or 2 rating.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: Baseline to: post-treatment (Day 0), Day 7, Day 30
• Results posted on: 2024-01-24

Participant Flow

Enrollment for the study was initiated April 22, 2013 and was completed June 28, 2013 at two investigational sites.

Participant milestones

Measure	Treatment With the Cryo-Touch III Device Treatment with Cryo-Touch III device
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device

Baseline characteristics by cohort

Measure	Treatment With the Cryo-Touch III Device n=19 Participants Treatment with Cryo-Touch III device
Age, Continuous	54.6 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Primary Diagnosis Stroke	16 Participants n=5 Participants
Primary Diagnosis Traumatic Brain Injury	2 Participants n=5 Participants
Primary Diagnosis Other: Spinal Cord Injury	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to: post-treatment (Day 0), Day 7, Day 30

The Modified Ashworth Scale (MAS) is 6-point scale designed to assess muscle tone and spasticity through the flexion or extension of a joint. Muscle response is graded on a scale from 0 (no increase in muscle tone) to 4 (affected parts rigid in flexion or extension). This includes a 1+ rating, which further distinguishes the types of increase in muscle tone from those described by a 1 or 2 rating.

Outcome measures

Measure	Treatment With the Cryo-Touch III Device n=19 Participants Treatment with Cryo-Touch III device
Decrease in Pain and Symptoms Caused by Hypertonia in the Upper Arm as Measured by an Improvement of 1 Point or Greater on the Modified Ashworth Scale (MAS) at Day 7 Average MAS score Baseline	3.3 average MAS Score, absolute Standard Deviation 0.7
Decrease in Pain and Symptoms Caused by Hypertonia in the Upper Arm as Measured by an Improvement of 1 Point or Greater on the Modified Ashworth Scale (MAS) at Day 7 Average MAS score post-treatment	1.3 average MAS Score, absolute Standard Deviation 0.8
Decrease in Pain and Symptoms Caused by Hypertonia in the Upper Arm as Measured by an Improvement of 1 Point or Greater on the Modified Ashworth Scale (MAS) at Day 7 Average MAS Score Day 7	1.7 average MAS Score, absolute Standard Deviation 0.9
Decrease in Pain and Symptoms Caused by Hypertonia in the Upper Arm as Measured by an Improvement of 1 Point or Greater on the Modified Ashworth Scale (MAS) at Day 7 Average MAS score Day 30	1.5 average MAS Score, absolute Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline to: post-treatment (Day 0), Day 7, Day 30

The Tardieu Scale uses the application of stretch at several velocities to quantify muscle response and assess muscle spasticity. Two specified velocities were assessed (V1 and V2). For each stretch, quality of muscle reaction (X) is recorded on a 6-point scale from 0 (no resistance throughout passive movement) to 5 (immovable joint).

Outcome measures

Measure	Treatment With the Cryo-Touch III Device n=19 Participants Treatment with Cryo-Touch III device
Improvement in Spasticity as Measured by the Tardieu Scale Average X Score V1 Baseline	1.7 average X Score, absolute Standard Deviation 0.4
Improvement in Spasticity as Measured by the Tardieu Scale Average X score V1 at post-treatment	1.1 average X Score, absolute Standard Deviation 0.7
Improvement in Spasticity as Measured by the Tardieu Scale Average X Score V1 at Day 7	1.2 average X Score, absolute Standard Deviation 0.7
Improvement in Spasticity as Measured by the Tardieu Scale Average X Score V1 at Day 30	0.8 average X Score, absolute Standard Deviation 0.7
Improvement in Spasticity as Measured by the Tardieu Scale Average X Score V2 at Baseline	1.9 average X Score, absolute Standard Deviation 0.3
Improvement in Spasticity as Measured by the Tardieu Scale Average X score V2 post-treatment	1.4 average X Score, absolute Standard Deviation 0.7
Improvement in Spasticity as Measured by the Tardieu Scale Average X Score V2 at Day 7	1.5 average X Score, absolute Standard Deviation 0.5
Improvement in Spasticity as Measured by the Tardieu Scale Average X Score V2 at Day 30	1.3 average X Score, absolute Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline to: post-treatment (Day 0), Day 7, Day 30

The Penn Spasm Score, which is a patient reported score, consists of two sub-scales: the spasm frequency score and the spasm severity scale3. The Penn spasm frequency is assessed on a 5-point scale from 0 (no spasms) to 4 (spasms occurring more than ten times per hour). The spasm severity scale consists of three ratings, which are 1 (mild), 2 (moderate) and 3 (severe).

Outcome measures

Measure	Treatment With the Cryo-Touch III Device n=19 Participants Treatment with Cryo-Touch III device
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score Average Penn Frequency Score baseline	1.3 Average Penn Spasm Score, absolute Standard Deviation 1.5
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score Average Penn Frequency Score Post-treatment	0.7 Average Penn Spasm Score, absolute Standard Deviation 1.1
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score Average Penn Frequency Score Day 7	0.7 Average Penn Spasm Score, absolute Standard Deviation 1.1
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score Average Penn Frequency Score Day 30	0.7 Average Penn Spasm Score, absolute Standard Deviation 1.0
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score Average Penn Severity Score Baseline	2.4 Average Penn Spasm Score, absolute Standard Deviation 0.5
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score Average Penn Severity Score Post-treatment	1.6 Average Penn Spasm Score, absolute Standard Deviation 0.7
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score Average Penn Severity Score Day 7	1.8 Average Penn Spasm Score, absolute Standard Deviation 0.8
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score Average Penn Severity Score Day 30	2.1 Average Penn Spasm Score, absolute Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline to: post-treatment (Day 0), Day 7, Day 30

The Fugl-Meyer Scale is an assessment consisting of 33 movements, each rated as "0" (cannot perform), "1" (can partially perform) or "2" (can perform fully). A Subject's score is the sum of their ratings on each of these items, where the maximum (best) score is a 66.

Outcome measures

Measure	Treatment With the Cryo-Touch III Device n=16 Participants Treatment with Cryo-Touch III device
Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only) Average Fugl-Meyer Sum Score Day 30	22.3 average Fugl-Meyer Sum Score, absolute Standard Deviation 19.9
Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only) Average Fugl-Meyer Sum Score Baseline	24.5 average Fugl-Meyer Sum Score, absolute Standard Deviation 17.9
Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only) Average Fugl-Meyer Sum Score post-treatment	27.3 average Fugl-Meyer Sum Score, absolute Standard Deviation 17.1
Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only) Average Fugl-Meyer Sum Score Day 7	24.6 average Fugl-Meyer Sum Score, absolute Standard Deviation 18.7

SECONDARY outcome

Timeframe: baseline to: post-treatment (Day 0), Day 7, Day 30

The NRS is an 11-point scale from 0 to 10, where lower scores represent less spasticity.

Outcome measures

Measure	Treatment With the Cryo-Touch III Device n=19 Participants Treatment with Cryo-Touch III device
Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score average NRS Score baseline	6.7 average NRS score, absolute Standard Deviation 2.0
Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score Average NRS score post-treatment	2.7 average NRS score, absolute Standard Deviation 1.5
Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score Average NRS score Day 7	3.5 average NRS score, absolute Standard Deviation 1.6
Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score Average NRS score Day 30	4.2 average NRS score, absolute Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline to: Post-treatment (Day 0), Day 7, Day 30

Visual Analog Scale assesses pain on a 0-10 point range. 0= no pain and 10 is the worst pain imaginable. Higher score is associated with a worse outcome.

Outcome measures

Measure	Treatment With the Cryo-Touch III Device n=19 Participants Treatment with Cryo-Touch III device
Improvement in Pain as Assessed by Visual Analog Scale (VAS) Average VAS score baseline	1.0 average VAS Score, absolute Standard Deviation 2.0
Improvement in Pain as Assessed by Visual Analog Scale (VAS) Average VAS score Post-treatment	0.4 average VAS Score, absolute Standard Deviation 0.8
Improvement in Pain as Assessed by Visual Analog Scale (VAS) Average VAS score Day 7	0.6 average VAS Score, absolute Standard Deviation 1.4
Improvement in Pain as Assessed by Visual Analog Scale (VAS) Average VAS score Day 30	1.2 average VAS Score, absolute Standard Deviation 2.1

SECONDARY outcome

Timeframe: Day 7, Day 30, Day 56, Day 84, Day 112

Population: Subjects reporting "effect" at Day 56 were followed to Day 84; those with effect at Day 84 continued to be followed to Day 112.

Subjects were asked to report the duration of treatment effect at Day 7,Day 30, and Day 56. Subjects could designate their results as "effect" "no effect" or "no longer effective". Subjects reporting "effect" at Day 56 were followed to Day 84; those with effect at Day 84 continued to be followed to Day 112.

Outcome measures

Measure	Treatment With the Cryo-Touch III Device n=19 Participants Treatment with Cryo-Touch III device
Duration of Treatment Effect Day 7	15 Participants
Duration of Treatment Effect Day 30	17 Participants
Duration of Treatment Effect Day 56	10 Participants
Duration of Treatment Effect Day 84	7 Participants
Duration of Treatment Effect Day 112	6 Participants

Adverse Events

Treatment With the Cryo-Touch III Device

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment With the Cryo-Touch III Device n=19 participants at risk Treatment with Cryo-Touch III device
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	5.3% 1/19 • Number of events 1 • Adverse event data was collected from Day 0-Treatment day to Day 56-EOS.
Skin and subcutaneous tissue disorders Cellulitis right side of scrotum and groin	5.3% 1/19 • Number of events 1 • Adverse event data was collected from Day 0-Treatment day to Day 56-EOS.

Other adverse events

Measure	Treatment With the Cryo-Touch III Device n=19 participants at risk Treatment with Cryo-Touch III device
Musculoskeletal and connective tissue disorders Soreness at triceps, left elbow	5.3% 1/19 • Number of events 1 • Adverse event data was collected from Day 0-Treatment day to Day 56-EOS.
Musculoskeletal and connective tissue disorders temporary increase in spasticity of treated extremity	5.3% 1/19 • Number of events 1 • Adverse event data was collected from Day 0-Treatment day to Day 56-EOS.
Nervous system disorders seizure	5.3% 1/19 • Number of events 1 • Adverse event data was collected from Day 0-Treatment day to Day 56-EOS.
Skin and subcutaneous tissue disorders edema left clavicular	5.3% 1/19 • Number of events 1 • Adverse event data was collected from Day 0-Treatment day to Day 56-EOS.

Additional Information

Medical Information

Pacira Bioscience, Inc.

Phone: 1-855-793-9729

Email: MedInfo@Pacira.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60