Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders and Spasticity (CRYONIC)

Universitair Ziekenhuis Brussel

Status: Not yet enrolling

Conditions: Spasticity; Chronic Musculoskeletal Pain; Cryo Analgesia; Cryoablation

Treatments: Procedure: cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT07289984

25428

UniversitairZB25428

Details and patient eligibility

About

The clinical study is titled the CRYONIC PROTOCOL, which stands for Cryotherapy for Neurolysis In Chronic Pain and spasticity. 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 and Spasticity. 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 and spasticity.

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 (those with chronic musculoskeletal pain or spasticity)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Chronic musculoskeletal pain group

Experimental group

Treatment:

Procedure: cryoablation