Could a freezing device loosen stiff muscles? new trial begins
NCT ID NCT06340451
First seen Jun 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study tests a device called iovera® that uses cold to calm overactive nerves causing muscle tightness in the arm and shoulder. About 132 adults with spasticity from a brain or spinal condition will get either the real device or a sham (fake) treatment. Researchers will measure changes in muscle stiffness over time to see if the device helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iovera® system (a device that delivers cold therapy to nerves to reduce muscle tightness)
- What this could lead to
- If it works, this could offer a non-drug option to reduce arm and shoulder stiffness in people with spasticity from brain or spinal conditions.
- What could go wrong
- This is an early-stage study with only 132 people, and it uses a sham comparison, so the real benefit may be small or no better than placebo. The device is temporary and may not work for everyone.
Why investors are watching
Pacira is testing its iovera system, a device that uses cold to numb nerves, in 132 people with arm and hand spasticity. The trial compares the real device against a sham version, and the result matters because iovera could become a new use for a product the company already sells. For a small company, a positive readout in a new condition could broaden its market beyond its current focus.
If it works: If the trial shows iovera eases spasticity better than the sham, Pacira could seek approval for this new use and expand its product's reach. That would give the company a second revenue stream from an existing device.
If it fails: The trial could fail to show a clear benefit, which would block that new use and leave Pacira relying on its current products. Clinical trials often fail, so investors should treat this readout as uncertain.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female, 18 years and above. 2. A confirmed diagnosis of any cerebral or spinal condition, at least 6 months before Screening, resulting in spasticity of the muscles controlling the shoulder and elbow. 3. Not on oral medications for spasticity management or if on any oral medications, the oral medication taken chronically for spasticity management (eg, oral baclofen) must be maintained at a stable dose for at least 4 weeks before screening for the study. 4. Not on an intrathecal baclofen pump or if on an intrathecal baclofen pump for spasticity management, must be maintained at a stable dose for six months or more before screening for the study. 5. 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). 6. 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. 7. Subject, in the investigator's opinion, will not be exposed to unacceptable risk by participation. 8. Able to provide informed consent, adhere to the study schedule, and complete all study assessments. Exclusion Criteria: 1. History of stroke, traumatic brain injury, and/or spinal cord injury in less than 6 months. 2. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, or Raynaud's disease. 3. History of neurotoxin injections within the past 3 months. 4. Previous injection with phenol or ethyl alcohol at any time in the target areas (shoulder or elbow). 5. Previous surgical intervention that altered the target neuroanatomy of the upper limb. 6. Current or planned enrollment in an investigational drug or device study for the management of spasticity for the duration of the study. 7. Medical instability that interferes with tolerability to spasticity treatment with the study device as per the investigator's discretion. 8. Any hospitalization within 4 weeks before Screening 9. Diagnosis of amyotrophic lateral sclerosis or any lower motor neuron conditions 10. Allergy or intolerance to amide local anesthetics. 11. Any skin condition in or around the target area that, in the opinion of the investigator, could adversely impact treatment. 12. Currently pregnant, nursing, or planning to become pregnant during the study. 13. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 14. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance. 15. Subject, in the opinion of the investigator, is not a suitable candidate for study participation (eg, history of multiple missed office visits, any related upper limb injury). 16. Subject is unable to adhere to the assessment schedule.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Center for Neurological Disorders - Gamma Therapeutic Center
Greenfield, Wisconsin, 53228, United States
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Cooper University Healthcare
Camden, New Jersey, 08103, United States
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Froedtert and Medical College of Wisconsin - Milwaukee
Milwaukee, Wisconsin, 53226-3548, United States
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Kansas Institute of Research - Kansas City Bone & Joint Clinic
Overland Park, Kansas, 66211, United States
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Moss Rehab Physical Medicine Associates
Elkins Park, Pennsylvania, 19027, United States
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Mount Sinai Health System - Faculty Practice Associates (FPA)
New York, New York, 10029-6501, United States
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Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
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Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
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Sarasota Memorial Hospital (SMH)
Sarasota, Florida, 34239-2921, United States
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Shepherd Center
Atlanta, Georgia, 30309, United States
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Source Healthcare - Santa Monica
Santa Monica, California, 90403, United States
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St. Luke's Rehabilitation Institute/Main Campus
Spokane, Washington, 99202, United States
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University of Missouri Health Care - University Hospital
Columbia, Missouri, 65212-0001, United States
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University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
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University of Texas Health Houston/TIRR
Houston, Texas, 77030, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
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Virginia iSpine Physicians, PC
Richmond, Virginia, 23238, United States
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Washington University School of Medicine
St Louis, Missouri, 63110-1032, United States