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

NCT07289984 | Not Yet Recruiting

• 2 other identifiers: UniversitairZB2542825428
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Musculoskeletal Pain; Cryo Analgesia; Cryoablation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (18)

• 2-Minute Walk Test (2MWT)

  3 months

• Timed Up and Go

  3 months

• Passive Range of Motion

  3 months

• Goal Attainment Scaling

  3 months

• Modified Tardieu Scale

  3 months

Study Arms (1)

Chronic musculoskeletal pain group

EXPERIMENTAL

Procedure: cryoablation

Interventions

cryoablation PROCEDURE

Cryoneurolysis

Chronic musculoskeletal pain group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

MeSH Terms

Interventions

Cryosurgery

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: April 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share