The clinical study is titled the CRYONIC PROTOCOL, which stands for Cryotherapy for Neurolysis In Chronic Pain. It is structured as a prospective, multi-cohort observational study.
Purpose of the Study:
The overarching purpose of the CRYONIC PROTOCOL study is to assess the Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders. The study focuses on evaluating the effectiveness of ultrasound-guided peripheral nerve cryoneurolysis, a minimally invasive technique that uses extreme cold to induce temporary nerve blocks, for patients with treatment-resistant chronic musculoskeletal pain.
The study also seeks to determine if cryoneurolysis itself leads to meaningful improvements in both pain intensity and functional ability in the included patient cohorts.
Be over 18 year old
Adults (> 18y) with either chronic musculoskeletal pain (> 3 months; average NRS > 5/10) or painful/functionally limiting spasticity
Have a clinical stable condition, > 3months
Any medications must be maintained on a stable schedule- Able to understand study instructions and provide informed consent (ICF) in French or Dutch.Provide written informed consent
Contraindication to cryoneurolysis such as a diagnosis of cryoglobulinemia, paroxysmal cold haemoglobinuria, cold urticaria, Raynaud's disease, any form of peripheral neuropathy, open and or infected wounds of the affected limb
Patient's refusal to give consent to the procedure or to use of their data for research purposes.
Ongoing local or systemic infection before the procedure.
Predominantly neuropathic pain of the upper extremity as assessed with the Pain Detect questionnaire
Single group
cryoablation
Procedure/SurgeryCryoneurolysis
Numeric Rating Scale (NRS)
Correlation between diagnostic nerve bloc and cryoneurolysis Numeric Rating Scale (NRS) for pain, range 0-10, higher scores indicate worse pain.
2-Minute Walk Test (2MWT)
A functional test measuring walking endurance (distance walked in 2 minutes); a practical measure of ambulatory capacity Two-Minute Walk Test (2MWT), outcome is total distance walked in meters in 2 minutes; there is no fixed minimum or maximum value, and higher distances indicate a better walking capacity.
Timed Up and Go
Measures the time taken to stand from a chair, walk 3m, turn, return, and sit, capturing basic mobility, balance, and fall risk Timed Up and Go (TUG), outcome is time to complete the task in seconds; there is no fixed minimum or maximum value, and higher times indicate worse mobility and higher fall risk.
Passive Range of Motion
Joint angle measurement using a goniometer at the treated joint(s)
Goal Attainment Scaling
An individualized, patient-centered goal measure; goals are pre-defined and scored on a 5-point scale Goal Attainment Scaling (GAS) is an individualized outcome measure in which patient-specific goals are defined and rated on a 5-point ordinal scale from -2 (much less than expected) to +2 (much more than expected).
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This trial is not recruiting at the moment. You can still explore other options:
