ContractureNCT06051656
Effect of Cryoneurolysis on Pain in Patients With Hand Contracture.
An observational study of Contracture and Spasticity, Muscle, run by Vancouver Island Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contracture, Spasticity, Muscle
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: 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).
Who may be able to join
- Adult patients(at least 18 years old).
- Severe claw hand with less than 4 cm distance between the pulp of the fingers and palm of the hand.
- MAS>= 3 in wrist and hand muscles interfering with function or causing a clinical problem, due to any neurological condition.
- Have refractory pain in wrist and hand areas with no response to the usual pain management methods including oral medication or botulinum toxin injection.
- Patients are already candidate for cryoneurolysis to manage the pain and spasticity in their hand and wrist, based on their response to diagnostic nerve block test (DNB).
- Ability to attend testing sessions, comply with testing protocols and provide written informed consent. For patients who physically are not able to complete the consent process, a witness may be asked to sign and confirm their willing for participation. Legal representative may be asked to help with consent process for participants who cognitively are not able to consent on their behalf.
Who cannot join
- Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity, including previous cryoneurolysis, chemical neurolysis, neurectomy or arthroplasty.
- Patients who received botulinum toxin in past 4 months in the same targeted muscles for cryoneurolysis, however, they may enter the study at the 4-month mark.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Victoria General Hospital
Victoria, British Columbia, V8Z 6R5
Mahdis Hashemi, MD, 250-727-4233, mahdis.hashemi@islandhealth.ca
About this study
Official title: Effect of the Cryoneurolysis on Pain and Positioning in Patients With Wrist and Hand Contractures.
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.
Read the detailed description
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.
- Conditions
- Contracture, Spasticity, Muscle
- Keywords
- Wrist contracture, Severe spasticity, Pain, Cryoneurolysis, Hand contracture
- Medical subject headings
- Contracture, Muscle Spasticity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The assessment will be done at baseline, 2 weeks, one and four months after the procedure.
Secondary outcomes (3)
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.
Measured: The assessment will be done at baseline, 2 weeks, one and four months after the procedure.
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)
Measured: 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
Measured: The assessment will be done at baseline and at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start9 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ContractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Island Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Winston, MD, Principal investigator, Vancouver Island Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051656
- Sponsor's protocol ID
- H22-03181
- Status last verified
- Sep 2023
- First submitted
- 1 Aug 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet.
Publications
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.
PubMed 18332384Diong 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.
PubMed 22450888Matozinho 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.
PubMed 31328966Schnitzler 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.
PubMed 26797076Ilfeld 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.
PubMed 29121277
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Cryoneurolysis on Pain and Positioning in Patients With Wrist and Hand Contractures.
- ClinicalTrials.gov ID
- NCT06051656
- Acronym / sponsor ID
- H22-03181
- Conditions
- Contracture, Spasticity, Muscle
- Keywords
- Wrist contracture, Severe spasticity, Pain, Cryoneurolysis, Hand contracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vancouver Island Health AuthorityUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 25 Sep 2023 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (6 listed)
- Adult patients(at least 18 years old).
- Severe claw hand with less than 4 cm distance between the pulp of the fingers and palm of the hand.
- MAS>= 3 in wrist and hand muscles interfering with function or causing a clinical problem, due to any neurological condition.
- Have refractory pain in wrist and hand areas with no response to the usual pain management methods including oral medication or botulinum toxin injection.
- Patients are already candidate for cryoneurolysis to manage the pain and spasticity in their hand and wrist, based on their response to diagnostic nerve block test (DNB).
Key exclusion criteria (2 listed)
- Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity, including previous cryoneurolysis, chemical neurolysis, neurectomy or arthroplasty.
- Patients who received botulinum toxin in past 4 months in the same targeted muscles for cryoneurolysis, however, they may enter the study at the 4-month mark.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Any changes in wrist and hand pain after cryoneurolysis.
Time frame: The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure.
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).
Any changes in wrist and hand pain after cryoneurolysis , in patients who are not cognitively able to report the intensity of pain.
Time frame: The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure.
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.
Any changes in wrist and hand spasticity and tone.
Time frame: The assessment will be done at baseline, 2 weeks, one and four months after the procedure.
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.
Any changes in wrist and hand range of motion will be recorded.
Time frame: The assessment will be done at baseline, 2 weeks, one and four months after the procedure.
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.
3 secondary outcomes
Any changes in maximum distance between pulp of the fingers and palm of the hand.
Time frame: The assessment will be done at baseline, 2 weeks, one and four months after the procedure.
Any changes in hand hygiene will be recorded.
Time frame: 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.
Time frame: The assessment will be done at baseline and at 4 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 18332384Clavet 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.
- Background: PubMed 22450888Diong 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.
- Background: PubMed 31328966Matozinho 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.
- Background: PubMed 26797076Schnitzler 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.
- Background: PubMed 29121277Ilfeld 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.
- Individual participant dataSharing planned: Undecided. Not decided yet.
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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. This study is not recruiting at the moment.
Paul Winston, MD principal investigator
Vancouver Island Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contracture and Spasticity, Muscle, run by Vancouver Island Health Authority at 1 site in Canada.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahdis Hashemi, MD (250-727-4233, mahdis.hashemi@islandhealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any changes in wrist and hand pain after cryoneurolysis. (time frame: The assessment will be done at baseline, 2 weeks, 1 and 4 months after the procedure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051656, which also lists 5 linked publications.
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 3 Oct 2023.