N/A
N=19
Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device
Upper Limb Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01863901 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
Jun 2023
Primary outcome: Primary: 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 — 3.3; 1.3; 1.7; 1.5 average MAS Score, absolute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treatment with Cryo-Touch III device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pacira Pharmaceuticals, Inc
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
3.3; 1.3; 1.7; 1.5 | — |
| SECONDARY Improvement in Spasticity as Measured by the Tardieu Scale |
1.7; 1.1; 1.2; 0.8; 1.9; 1.4 | — |
| SECONDARY Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score |
1.3; 0.7; 0.7; 0.7; 2.4; 1.6 | — |
| SECONDARY Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only) |
24.5; 27.3; 24.6; 22.3 | — |
| SECONDARY Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score |
6.7; 2.7; 3.5; 4.2 | — |
| SECONDARY Improvement in Pain as Assessed by Visual Analog Scale (VAS) |
1.0; 0.4; 0.6; 1.2 | — |
| SECONDARY Duration of Treatment Effect |
15; 17; 10; 7; 6 | — |
Summary
A proof of concept study to evaluate the feasibility of safe and effective treatment of upper limb spasticity using the Cryo-Touch III Device.
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years of age and older.
- Trial participants must have a confirmed diagnosis that results in spasticity involving muscle innervated by the musculocutaneous nerve (MCN).
- Any medications must be maintained on a stable schedule for at least two weeks prior to treatment. No washout period is allowed.
- Must have an average score on the Modified Ashworth Scale for Spasticity of ≥ 2 over the last 30 days in the elbow.
- Subject, in the Investigator's opinion, will not be exposed to unacceptable risk by participation.
Exclusion Criteria
- Previous surgical intervention that altered the target neural anatomy of the upper limb.
- Any injection (neurolytic, sclerosing, anesthetic, etc.) to the upper limb within the last 4 months.
- Current enrollment in an investigational drug or device study that specifically targets spasticity management.
- Allergy or intolerance to local anesthesia.
- Any local skin condition at the treatment site that in the investigator's opinion would adversely affect treatment or outcomes.
- Any chronic medication use (prescription, over-the-counter, etc.) that in the investigator's opinion would affect study participation or subject safety.
- Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, open and/or infected wounds.
- Diagnosis of progressive neurologic diseases such as ALS.
- For any reason, in the opinion of the investigator, the subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, any related upper limb injury, etc.).
Data sourced from ClinicalTrials.gov (NCT01863901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.