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Contracture which is defined as a limitation of the maximum passive range of motion due to changes in periarticular soft tissue can contributes to severe pain and increased disabilities. Once contracture is present, management options are very limited and mainly includes surgery. This clinic offers cryoneurolysis routinely to spastic patients to manage their severe spasticity, contracture and associated pain. In this observational project, the outcomes after cryoneurolysis in patients with wrist and hand contracture will be studied systematically and with more details to determine any changes in pain and range of motion after this procedure.
Contracture is defined as a limitation of the maximum passive range of motion of a joint due to shortening and changes of periarticular soft tissue structures. Contracture contributes to severe pain, increased disabilities, decreased functional range of motion and decreased functional range of motion in daily living. The incidence of contracture in first year after has been recorded to be as high as 66%and up to 28% within 3 months after stroke. There are many pharmacological and non pharmacological guidelines available for treatment of contracture and associated pain, including botulinum toxin injection, physiotherapy, stretching and positioning, though; the surgery has been recommended as the most effective one .
Cryoneurolysis is a novel procedure that causes nerve degeneration by cooling them to -88°. The first step in this procedure is isolating the targeted nerves with ultrasound guidance and e-stimulation for motor nerves and mixed sensory motor nerves for pain management. To select the proper candidate for this procedure, targeted nerves will be temporary paralyzed by blocking them with lidocaine (DNB). In this clinic after successful DNB to reduce pain and muscle tone, the patient is offered cryoneurolysis. After rapid cooling the nerve to a certain degree the axon and myelin of targeted zone will be disrupted however ; the basal lamina, epineurium and perineurium of the targeted nerves will be remained intact and serve as a tube for neural regeneration.
This observational study, proposes to measure the effect of cryoneurolysis prospectively and systematically on pain reduction in patients with wrist and hand severe spasticity or contracture due to any underlying disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Any adult patient with severe hand and wrist spasticity or contracture who suffers from a refractory pain, and is already candidate for cryoneurolysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Any changes in wrist and hand pain after cryoneurolysis. | The intensity of pain in wrist and hand area will be measured based on numerical rating scale (NRS) on scale of 0 to 10 (0 means no pain at all and 10 shows the worst pain that the patient reports). | The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure. |
| Any changes in wrist and hand pain after cryoneurolysis , in patients who are not cognitively able to report the intensity of pain. | Patients who cognitively are not able to score their pain based on NRS, will be assessed by checklist of nonverbal pain indicators (CNPI). In this scale the patients will be observed in rest and during any movement, and any non verbal or verbal complaints, facial grimaces, bracing, restlessness, rubbing of the affected area will be recorded. The presence or absence of these symptoms will be recorded. | The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure. |
| Any changes in wrist and hand spasticity and tone. | The degree of spasticity will be measured based on Modified Ashworth Scale (MAS) . This scale has 6 scores from 0 which means no spasticity to 4 which means the maximum tone in which the limb movement is limited. | The assessment will be done at baseline, 2 weeks, one and four months after the procedure. |
| Any changes in wrist and hand range of motion will be recorded. | Maximum passive and active range of motion of wrist , second and fifth metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints and thumb radial and palmar abduction will be measured using a goniometer. | The assessment will be done at baseline, 2 weeks, one and four months after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Any changes in maximum distance between pulp of the fingers and palm of the hand. | The maximum distance between the pulp of most flexed finger and palm of the hand will be measured in centimetre. The same measurement will be done for distance between pulp of thumb and palm of the hand. | The assessment will be done at baseline, 2 weeks, one and four months after the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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Any adult patient with wrist/hand contracture and a refractory pain who is already a candidate for cryoneurolysis based on their response to the diagnostic nerve block test (DNB).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahdis Hashemi, MD | Contact | 250-727-4233 | mahdis.hashemi@islandhealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Paul Winston, MD | Vancouver Island Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria General Hospital | Recruiting | Victoria | British Columbia | V8Z 6R5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18332384 | Background | Clavet H, Hebert PC, Fergusson D, Doucette S, Trudel G. Joint contracture following prolonged stay in the intensive care unit. CMAJ. 2008 Mar 11;178(6):691-7. doi: 10.1503/cmaj.071056. | |
| 22450888 | Background | Diong J, Harvey LA, Kwah LK, Eyles J, Ling MJ, Ben M, Herbert RD. Incidence and predictors of contracture after spinal cord injury--a prospective cohort study. Spinal Cord. 2012 Aug;50(8):579-84. doi: 10.1038/sc.2012.25. Epub 2012 Mar 27. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 9, 2023 | Jul 28, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003286 | Contracture |
| D009128 | Muscle Spasticity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| D009122 | Muscle Hypertonia |
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| Any changes in hand hygiene will be recorded. | Patients' hands will be assessed to determine the extent of any palm maceration, ulceration or infection; cleanliness of the palm, ease of cleaning and nail trimming; and the effect of hygiene-related disabilities on other area of functioning. This assessment is a part of disability assessment scale (DAS). Each section's score ranges from 0 to 3 (0= no disability and 3 = maximum disability) | The assessment will be done at baseline, 2 weeks, one and four months after the procedure. |
| Patients satisfaction on pre set goals, after the procedure. | Goal attainment scale (GAS) is a patient oriented scale to score patients satisfaction with their desired outcomes. Before the procedure up to 3 individualized goals will be negotiated between patients, their caregivers and physicians. At the final visit they will be asked if they are satisfied with each of these goals, and their responses will be scored accordingly. The scores of (-2), (-0.5), (0), (+1) and (+2) will be assigned if they feel that their condition is worse than before, better but not as good as expected, as expected, better than expected and much better than expected. All goals will be weighted equally, and final score will be calculated based on the available formula. The higher score is presenting of better outcome | The assessment will be done at baseline and at 4 months. |
| 31328966 | Background | Matozinho CVO, Teixeira-Salmela LF, Samora GAR, Sant'Anna R, Faria CDCM, Scianni A. Incidence and potential predictors of early onset of upper-limb contractures after stroke. Disabil Rehabil. 2021 Mar;43(5):678-684. doi: 10.1080/09638288.2019.1637949. Epub 2019 Jul 22. |
| 26797076 | Background | Schnitzler A, Diebold A, Parratte B, Tliba L, Genet F, Denormandie P. An alternative treatment for contractures of the elderly institutionalized persons: Microinvasive percutaneous needle tenotomy of the finger flexors. Ann Phys Rehabil Med. 2016 Apr;59(2):83-6. doi: 10.1016/j.rehab.2015.11.005. Epub 2016 Jan 13. |
| 29121277 | Background | Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis for treatment of acute pain: could cryoanalgesia replace continuous peripheral nerve blocks? Br J Anaesth. 2017 Oct 1;119(4):703-706. doi: 10.1093/bja/aex142. No abstract available. |
| D020879 |
| Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |