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

NCT ID: NCT07289984

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2031-08-01

Brief Summary

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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)

Detailed Description

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Conditions

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Spasticity Chronic Musculoskeletal Pain Cryo Analgesia Cryoablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronic musculoskeletal pain group

Group Type EXPERIMENTAL

cryoablation

Intervention Type PROCEDURE

Cryoneurolysis

Interventions

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cryoablation

Cryoneurolysis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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25428

Identifier Type: OTHER

Identifier Source: secondary_id

UniversitairZB25428

Identifier Type: -

Identifier Source: org_study_id