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Procedure

iovera° System for Muscle Spasms

Phase 3
Recruiting
Research Sponsored by Pacira Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a score on the Modified Ashworth Scale of 2 or more in the targeted area (shoulder and elbow) at Screening and at Baseline (Day-1 pretreatment)
A diagnostic nerve block using lidocaine (1% lidocaine, 2 to 3 mL per target nerve) showing a positive response (at least one point reduction from the screening Modified Ashworth Scale score for elbow extension and shoulder abduction) to the targeted nerves, should be performed within 30 days to at least 6 hours before study treatment. The diagnostic nerve block effect must be completely resolved before pretreatment evaluation and the study treatment
Must not have
Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, or Raynaud's disease
Any hospitalization within 4 weeks before Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 1 post-treatment, week 3, week 7, and week 13
Awards & highlights

Summary

This trial will test a new system called iovera° for treating upper extremity spasticity. They will enroll 132 subjects and randomly assign them to receive either the iovera° treatment

Who is the study for?
This trial is for adults with cerebral palsy or muscle spasms causing stiffness in the shoulder and elbow. Participants must have been diagnosed at least 6 months prior, not be on varying oral spasticity meds, or if using a baclofen pump, it should be stable for six months. They need to show improvement after a lidocaine nerve block test.Check my eligibility
What is being tested?
The study tests the iovera° system's effectiveness and safety against sham treatment in reducing upper extremity spasticity. Of the participants, two-thirds will receive actual iovera° treatment while one-third will get a sham procedure, decided randomly.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include pain at the treatment site, potential nerve injury from incorrect application of the system or device malfunctioning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My shoulder and elbow stiffness is moderate or severe.
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I had a nerve block test with lidocaine that improved my muscle stiffness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a condition affected by cold, such as cryoglobulinemia, cold urticaria, or Raynaud's.
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I have not been hospitalized in the last 4 weeks.
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I have had phenol or ethyl alcohol injections in my shoulder or elbow.
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I've had surgery that changed the structure of my upper limb's nerves.
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I am or will be part of a study for spasticity treatment during this trial.
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I have been diagnosed with ALS or a similar nerve condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 1 post-treatment, week 3, week 7, and week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 post-treatment, week 3, week 7, and week 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the Modified Ashworth Scale score for elbow measured (0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity)
Secondary outcome measures
Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff (-2 to +2, where lower score represents less expected outcomes, and higher scores represent greater expected outcomes)
Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured
Change from baseline in the Modified Tardieu Scales for elbow (0 to 5, where lower score represents no resistance, and higher score represents joint immobility; Increase in angle from baseline [R1, and R2] represents improvement)
+1 more
Other outcome measures
Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff
Change from baseline in the Modified Ashworth Scale score for elbow measured immediately (within 3 hours)
Change from baseline in the Modified Ashworth Scale score for shoulder (forward flexion, external rotation) measured immediately (within 3 hours)
+6 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: iovera° system treatmentActive Control1 Intervention
Group II: sham iovera° system treatmentPlacebo Group1 Intervention

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Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor
136 Previous Clinical Trials
13,849 Total Patients Enrolled
~88 spots leftby Apr 2025