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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Musculoskeletal Pain; Cryoablation; Cryo Analgesia
• Intervention / Treatment: Procedure: cryoablation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chronic musculoskeletal pain group	Procedure: cryoablation; Cryoneurolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Passive Range of Motion	Joint angle measurement using a goniometer at the treated joint(s)	3 months
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.	3 months
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.	3 months
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).	3 months
Modified Tardieu Scale	Assesses spasticity across velocities; considered to have better construct validity for velocity-dependence than MAS The Modified Tardieu Scale (MTS) is a clinical measure of spasticity, assessing a muscle's response to passive stretch at different velocities and recording both muscle reaction quality and the angle at which it occurs. It uses standardized stretch velocities (V1 very slow, V2 gravity speed, V3 as fast as possible) and scores the quality of muscle reaction from 0 (no resistance) to 5 (joint immobile), while also documenting R1 (angle of catch at fast stretch) and R2 (full passive range at slow stretch) to distinguish dynamic spasticity from fixed contracture	3 months
Modified Ashworth Scale	Clinician-rated 6-point ordinal scale quantifying muscle tone (resistance to passive movement) The Modified Ashworth Scale (MAS) is a 0-4 rating scale (with an additional grade 1+) that describes how much resistance is felt during passive movement of a muscle group. A score of 0 means no increase in muscle tone (normal tone), whereas a score of 4 indicates a rigid limb in flexion or extension. Higher scores on the MAS represent greater spasticity/increased muscle tone and therefore a worse outcome in terms of tone control.	3 months
Oswestry Disability Index (Low Back Pain)	Measures disability related to low back pain across 10 items focused on daily functioning Oswestry Disability Index (ODI) for Low Back Pain, score reported as a percentage from 0-100%, where higher scores indicate worse disability.	3 months
Shoulder Pain and Disability Index (Shoulder)	A self-administered questionnaire consisting of 13 items (5 for pain, 8 for disability) scored from 0 to 10 Shoulder Pain and Disability Index (SPADI), total score expressed as a percentage from 0-100%, where higher scores indicate worse shoulder pain and disability.	3 months
Disabilities of the Arm, Shoulder, and Hand (Arm/Shoulder)	A 30-item questionnaire evaluating upper limb function and symptoms Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, total score expressed from 0-100, where higher scores indicate greater upper-extremity disability and worse function.	3 months
Hip Disability and Osteoarthritis Outcome Score (Hip)	Assesses hip-related pain, symptoms, activities of daily living, and QoL across five subscales. Hip Disability and Osteoarthritis Outcome Score (HOOS), subscale scores transformed to a 0-100 scale, where higher scores indicate better hip-related health (less pain, fewer symptoms, better function, better quality of life).	3 months
Knee Injury and Osteoarthritis Outcome Score (Knee)	Measures knee-related outcomes across five domains, including pain, symptoms, activities of daily living, and QoL Knee Injury and Osteoarthritis Outcome Score (KOOS), subscale scores transformed to a 0-100 scale, where higher scores indicate better knee-related health (less pain, fewer symptoms, better function, better quality of life).	3 months
Work Ability Index	A 10-item questionnaire evaluating current work ability compared with the lifetime best, considering physical and mental demands and the impact of existing diseases Work Ability Index (WAI), total score range 7-49 points, where higher scores indicate better work ability (7 = very poor work ability, 49 = excellent work ability).	3 months
Medication Quantification Scale (Version III)	A validated tool to quantify the overall burden of pain medication based on pharmacological class, risk, and dose Medication Quantification Scale (Version III), total score is an open-ended numeric value calculated by summing weighted scores for each pain medication; higher scores indicate a higher overall medication burden and greater potential detriment (worse outcome).	3 months
Pain Self-Efficacy Questionnaire	Measures a patient's confidence in performing daily activities despite pain (10 items, scored 0 to 6) Pain Self-Efficacy Questionnaire (PSEQ), total score range 0-60, where higher scores indicate better pain self-efficacy (greater confidence in functioning and managing daily activities despite pain).	3 months
Tampa Scale for Kinesiophobia (11 items)	Tampa Scale for Kinesiophobia (TSK-11), total score range 11-44, where higher scores indicate greater kinesiophobia (more fear of movement/(re)injury and stronger fear-avoidance beliefs).	3 months
EuroQol 5 Dimensions, 5 Levels	A standardized instrument measuring general health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L), reported as a health state profile plus an index and a VAS: health states are coded from 11111-55555 and converted to a country-specific index value (typically ranging from negative values up to 1, where 1 indicates full health), and the EQ VAS ranges from 0-100 with higher scores indicating better self-rated health.	3 months
Patient-Reported Outcomes Measurement Information System - 29 items	Evaluates seven health domains, including physical function, anxiety, fatigue, and sleep disturbance Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29 Profile), domain scores are converted to T-scores with a mean of 50 and standard deviation of 10 in the reference population; higher T-scores indicate more of the domain being measured (e.g. higher = worse for anxiety, depression, pain interference, fatigue and sleep disturbance; higher = better for physical function and participation in social roles).	3 months
Brief Pain Inventory	Assesses both pain severity (scale 0-10) and the interference of pain with daily activities Brief Pain Inventory (BPI), pain severity and pain interference scores each range from 0-10 (derived as the mean of 0-10 item ratings), where higher scores indicate worse pain intensity and greater pain-related interference with daily functioning.	3 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Surgical Procedures, Operative; Ablation Techniques; Cryosurgery
• Other Study ID Numbers: UniversitairZB25428; 25428 (Other Identifier: UniversitairZB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No