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| ID | Type | Description | Link |
|---|---|---|---|
| 25428 | Other Identifier | UniversitairZB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic musculoskeletal pain group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryoablation | Procedure | Cryoneurolysis |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| Passive Range of Motion | Joint angle measurement using a goniometer at the treated joint(s) | 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 |