Chronic Musculoskeletal PainCRYONICNCT07289984
Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders
A study testing cryoablation in people with Chronic Musculoskeletal Pain and Cryo Analgesia, run by Universitair Ziekenhuis Brussel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain, Cryo Analgesia, Cryoablation
- What is being tested?
- cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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:
Read more
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
- Being tested
- cryoablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablationProcedure or surgery
Cryoneurolysis
| Study group | Role | What they receive |
|---|---|---|
| Chronic musculoskeletal pain group | Experimental | Not described Receives: Procedure: cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (18)
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.
Measured: 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.
Measured: 3 months
Passive Range of Motion
Joint angle measurement using a goniometer at the treated joint(s)
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 May 2030 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289984
- Sponsor's protocol ID
- UniversitairZB25428
- Other IDs
- 25428
- Acronym
- CRYONIC
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders
- ClinicalTrials.gov ID
- NCT07289984
- Acronym / sponsor ID
- CRYONIC / UniversitairZB25428
- Conditions
- Chronic Musculoskeletal Pain, Cryo Analgesia, Cryoablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic musculoskeletal pain group | Experimental | Procedure: cryoablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryoablationCryoneurolysis | Procedure or surgery | Chronic musculoskeletal pain group |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: 3 months
Correlation between diagnostic nerve bloc and cryoneurolysis Numeric Rating Scale (NRS) for pain, range 0-10, higher scores indicate worse pain.
18 secondary outcomes
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
Medication Quantification Scale (Version III)
Time frame: 3 months
Pain Self-Efficacy Questionnaire
Time frame: 3 months
Tampa Scale for Kinesiophobia (11 items)
Time frame: 3 months
EuroQol 5 Dimensions, 5 Levels
Time frame: 3 months
Patient-Reported Outcomes Measurement Information System - 29 items
Time frame: 3 months
Brief Pain Inventory
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cryoablation in people with Chronic Musculoskeletal Pain and Cryo Analgesia, run by Universitair Ziekenhuis Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.