The clinical study is titled the CRYONIC PROTOCOL, which stands for Cryotherapy for Neurolysis In Chronic Pain and spasticity. 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 and Spasticity. 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 and spasticity. 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 (those with chronic musculoskeletal pain or spasticity)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Cryoneurolysis
Numeric Rating Scale (NRS)
Correlation between diagnostic nerve bloc and cryoneurolysis
Time frame: 3 months
2-Minute Walk Test (2MWT)
A functional test measuring walking endurance (distance walked in 2 minutes); a practical measure of ambulatory capacity
Time frame: 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
Time frame: 3 months
Passive Range of Motion
Joint angle measurement using a goniometer at the treated joint(s)
Time frame: 3 months
Goal Attainment Scaling
An individualized, patient-centered goal measure; goals are pre-defined and scored on a 5-point scale
Time frame: 3 months
Modified Tardieu Scale
Assesses spasticity across velocities; considered to have better construct validity for velocity-dependence than MAS
Time frame: 3 months
Modified Ashworth Scale
Clinician-rated 6-point ordinal scale quantifying muscle tone (resistance to passive movement)
Time frame: 3 months
Oswestry Disability Index (Low Back Pain)
Measures disability related to low back pain across 10 items focused on daily functioning
Time frame: 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
Time frame: 3 months
Disabilities of the Arm, Shoulder, and Hand (Arm/Shoulder)
A 30-item questionnaire evaluating upper limb function and symptoms
Time frame: 3 months
Hip Disability and Osteoarthritis Outcome Score (Hip)
Assesses hip-related pain, symptoms, activities of daily living, and QoL across five subscales (higher scores indicate better outcomes)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months
Pain Self-Efficacy Questionnaire
Measures a patient's confidence in performing daily activities despite pain (10 items, scored 0 to 6)
Time frame: 3 months
Tampa Scale for Kinesiophobia (11 items)
Assesses fear of movement or (re)injury; higher scores (11 to 44) indicate more kinesiophobia
Time frame: 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
Time frame: 3 months
Patient-Reported Outcomes Measurement Information System - 29 items
Evaluates seven health domains, including physical function, anxiety, fatigue, and sleep disturbance
Time frame: 3 months
Brief Pain Inventory
Assesses both pain severity (scale 0-10) and the interference of pain with daily activities
Time frame: 3 months
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