Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cryoablation.
- Who it may be relevant to
- Registry conditions: Chronic Musculoskeletal Pain, Cryo Analgesia, Cryoablation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure cryoablation
Cryoneurolysis
Primary outcome measures
- Numeric Rating Scale (NRS) [Time frame: 3 months]
Secondary outcome measures (12)
- 2-Minute Walk Test (2MWT) [Time frame: 3 months]
- Timed Up and Go [Time frame: 3 months]
- Passive Range of Motion [Time frame: 3 months]
- Goal Attainment Scaling [Time frame: 3 months]
- Modified Tardieu Scale [Time frame: 3 months]
- Modified Ashworth Scale [Time frame: 3 months]
- Oswestry Disability Index (Low Back Pain) [Time frame: 3 months]
- Shoulder Pain and Disability Index (Shoulder) [Time frame: 3 months]
- Disabilities of the Arm, Shoulder, and Hand (Arm/Shoulder) [Time frame: 3 months]
- Hip Disability and Osteoarthritis Outcome Score (Hip) [Time frame: 3 months]
- Knee Injury and Osteoarthritis Outcome Score (Knee) [Time frame: 3 months]
- Work Ability Index [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07289984 · UniversitairZB25428 · 25428