Shoulder PainNCT05674604
Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
An observational study of Shoulder Pain and Knee Pain, run by Vancouver Island Health Authority at 1 site in Canada.
Trial summary
The purpose of the study is to measure the outcomes of a standard care, an ultrasound guided mini-invasive percutaneous procedure, performed on recent stroke patients on reduces pain, increases function \& quality of life The primary objective of the project is to reduce shoulder and/or knee pain in patients who have… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Pain, Knee Pain, Spasticity
- What is being tested?
- Cryoneurolysis
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 10 Oct 2022to Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with an acute neurological disorder, within 16 weeks, who have been referred to the Victoria General Hospital for rehabilitation and are already candidate for cryoneurolysis to manage their shoulder and/or knee pain.
Who may be able to join
- Adult inpatients at any hospital in the Greater Victoria Area or referred to Victoria General hospital for rehabilitation with the chief complaint of an acute neurological condition (within sixteen weeks) including but not limited to stroke and traumatic brain injury. People that have had a stroke or neurological event within sixteen weeks but have been discharged to outpatient rehab at Victoria General Hospital are also candidates
- In addition to their chief complaint, are also affected by one or both of the following
- Hemiplegic shoulder pain,
- Knee pain due to osteoarthritis
- Patients who are already candidate for cryoneurolysis.
- Ability to attend testing sessions, comply with testing protocols and provide either written or verbal informed consent. If necessary, a witness will be asked to sign the consent form and confirm the participant signature. For those patients who do not have the capacity to sign the consent form(Based on evaluation by PI or the recorded assessment by their physician in their medical charts) the designated care provider or family member will be asked to sign the ICF on behalf of them. Evaluation of the capacity to understand and communicate are part of routine assessment and are done routinely and each visit by physicians.
- Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
Who cannot join
- Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity or pain. Relevant treatments included but not limited to previous cryoneurolysis, previous chemical neurolysis, neurectomy or arthroplasty.
- Patients who received botulinum toxin in the past 4 months in the same targeted muscles for cryoneurolysis
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Victoria General Hospital
Victoria, British Columbia, V8Z 6R5
Paul Winston, MD, 250-727-4221, Paul.winston@viha.ca
Mahdis Hashemi, MD, 250-727-4221, mahdis.hashemi@viha.ca
About this study
Official title: Cryoneurolysis as a Drug Free Novel Treatment for Knee and Shoulder Pain Impairing Inpatient Neurological Rehabilitation
The purpose of the study is to measure the outcomes of a standard care, an ultrasound guided mini-invasive percutaneous procedure, performed on recent stroke patients on reduces pain, increases function \& quality of life
The primary objective of the project is to reduce shoulder and/or knee pain in patients who have had a stroke so that they can more readily engage in rehabilitation.
Secondary objectives are to reduce analgesic medications, increase independence and improve range of motion, to promote non-drug treatment measures in the medical toolkit, and to include an interdisciplinary care team in patient selection for interventions.
Read the detailed description
Hemiplegic shoulder pain (HSP) is the most common pain disorder after stroke and one of the four most common complications. The estimated incidence ranges from of 30%-70%. HSP is associated with reductions in function, interference with rehabilitation efforts , and a reduced quality of life .Onset of HSP is rapid, occurring as soon as a week after stroke in 17% of patients.While ubiquitous, the management of HSP represents a complex treatment pathway that has insufficient evidence supporting one particular treatment.
The pain associated with HSP may be due to heterogeneous causes. In the acute setting, decreased ROM in the shoulder may represent several processes including the early onset of spasticity, capsular pattern stiffness, glenohumeral pathology, or a component of complex regional pain syndrome (CRPS). Effective management of the HSP with decreased ROM requires assessment of each possible contributor. The suprascapular nerve provides up to 70% of the sensory fibers to the shoulder. Targeting the suprascapular nerve to reduce pain from stroke has been study with both nerve blocks and radiofrequency ablation. Cryoneurolysis to treat shoulder pain has also been proposed in recent years.
The lack of early recognition and treatment of HSP can lead to worsening limb function, increased pain, and may impair the rehabilitation and recovery process Early intervention may reduce the risk and onset of contracture, which can lead to significant impairments and a reduced quality of life. The incidence of developing at least one contracture in stroke patients within six months of their stroke is estimated at 52%.Contractures are a source of pain and limited ROM, and limit function while stretching has not been shown to be clinically effective. Patients with contractures and limited volitional control of their shoulder muscles, can experience maceration, skin dehiscence, impaired hygiene, and difficulty dressing, thus more invasive surgery may be required.
Knee osteoarthritis is ubiquitous in the aging population. Many stroke patients may have been pre-stroke poor candidates for a total knee arthroplasty due to medical frailty. Participants recovering from stroke, with pre-existing arthritis perceived that their arthritis "held them back" from an expected stroke recovery trajectory.In this study; "This slowed stroke recovery was attributed to daily pain, frustration, mobility limitations, and the required extra coping due to arthritis. As a result, comorbid arthritis increased the complexity of stroke recovery and rehabilitation."
This group has been global pioneers in the use of cryoneurolysis to treat spasticity.The process first involves isolating the nerves with ultrasound guidance and e-stimulation for motor nerves. A diagnostic nerve block is then performed to assess if spasticity is reduced, and range of motion and ease of movement occurs, as well as pain reduction. After a successful nerve block the patient then goes on to have cryoneurolysis which is performed using a small 1.2 to 1.3 mm diameter cryoprobe that is inserted percutaneously to targeted peripheral nerves. It has an established history over more than fifty years for lasting pain relief from months to years, when used for sensory nerves. Cryoneurolysis is possible due to the process of throttling a gas through an orifice from high to low pressure resulting in a rapid expansion of the gas and a drop in temperature, known as the Joule-Thomson effect. The rapid cooling generates an ice ball or oval between 3.5 and 18 mm that is formed at the tip of the with compressed CO2 or N2O at temperatures typically between -60 to -88° C. The ball or oval creates a targeted zone of axon and myelin disruption. This results in loss of axon continuity due to Wallerian degeneration of the targeted nerve extending outward from the lesion over a limited distance. However, the basal lamina, epineurium and perineurium of the targeted nerve remain intact and serve as a conduit or tube for neural regeneration.
Development of the ViVe algorithm to create a team based assessment tool to isolate the sources of Hemiplegic pain. This allows us to select patient that would benefit from cryoneurolysis to both the suprascapular nerve as well as the nerves to the spasticity muscles of the upper limb. Similarly, cryoneurolysis has been shown to be effective in managing osteoarthritis, a limiting factor for stroke rehabilitation.
There are 50,000 new strokes in Canada every year. Direct costs for 12-month stroke survivors are 4 times higher than direct costs for patients with stroke without spasticity during the first year after the event.
It has been demonstrating that cryoneurolysis has long lasting effects Over 100 patients, mostly with chronic neurologic disorders, received cryoneurolysis as a part of their standard care in this center and their outcomes are being measured and assessed . The number of these patients exceeding rapidly and it is essential to assess treating patients much earlier, in acute phase, to assess the reduction in pain, disability, and lengths of stay.
PURPOSE The purpose of this study is to measure the outcomes of a standard care procedure called cryoneurolysis. This will include any changes in pain and spasticity in an inpatient setting and for adult patients with an acute neurological condition who suffer from Hemiplegic Shoulder Pain (HSP) and or osteoarthritis of the knee and will receive this procedure as a part of their treatment and based on available guidelines.
- Conditions
- Shoulder Pain, Knee Pain, Spasticity, Pain, Acute Stroke
- Being tested
- Cryoneurolysis
- Keywords
- Cryoneurolysis, shoulder pain, knee pain, spasticity, acute stroke, In-patient setting
- Medical subject headings
- Shoulder Pain, Muscle Spasticity, Pain, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisProcedure or surgery
This is on observational study. All participants are already candidate for cryoneurolysis. Cryoneurolysis uses a cold probe to generate an ice ball, which initiates Wallerian Degeneration, a process where axon is destroyed but the epineurium and perineurium remain intact. The treated nerve is able to regenerate over time due to this preserved tube.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Adult inpatients who are referred to Victoria General Hospital for rehabilitation with the chief complaint of an acute neurological disorder such as stroke, within next 16 weeks, and suffer from shoulder and/or knee pain. All potential participants are already candidate for cryoneurolysis to mange their shoulder or knee pain. Receives: Procedure: Cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine any changes in shoulder pain, after the cryoneurolysis.
To do the assessment a questionnaire, Shoulder Pain and Disability Index (SPADI), will be used. This self-administered questionnaire consists of 2 dimensions, one for pain and the other for functional activities with total of 13 questions. Each question is scored on scale of 0 to 10 (0=no pain or difficulty and 10= the worst pain and the most difficulty). The higher total score is equal to more pain and more difficulty in doing the mentioned tasks.
Measured: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
to determine any changes in shoulder pain, based on physician's assessment, after the cryoneurolysis.
To do the assessment a pain assessment scale named SAAPS (Spasticity- Associated Arm Pain Scale) will be used. The SAAPS collects data on the verbal/ physiological response to passive range of motion (ROM) in five arm segments . The intensity of pain will be scored from 0 (no pain) to 3 (immediate pain on movement). The sum score ranges from 0 to 15, while the higher score is indicative of more pain.
Measured: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
to determine any changes in knee pain, after the cryoneurolysis
To score the pain intensity a questionnaire named WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)will be used. The questionnaire has 24 questions about pain, stiffness and physical function. Each question will be scored from 0 (no difficulty or pain ) to 4 (extreme pain and difficulty). Total score will be calculated out of 100 and higher score presents the worst pain and difficulty.
Measured: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
the degree of range of motion changes after the cryoneurolysis.
to evaluate any changes in shoulder and knee passive and active range of motion after the procedure. The range will be measured by goniometer and will be shown in degrees. The higher degree presents , more range of motion.
Measured: The assessment will be done before and 1 week, 1 and 4 months after the procedure.
The degree of changes in targeted muscles tone.
to evaluate any changes in shoulder and knee tone after the procedure. The assessment will be done during shoulder abduction, flexion, external rotation and knee flexion passive movement.The tone will be scored based on Modified Ashworth Scale, from 0 to 4. (0= no tone, 4 = maximum tone)
Measured: The assessment will be done before and 1 week, 1 and 4 months after the procedure.
Secondary outcomes (5)
Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale (Turner-Stokes, 2009)
Patients will be asked about their main times and at the end of the study, they will be asked if they are happy with result. Their response will be scored from -2 to +2 (Getting worse to more than expected improvement)
Measured: Goals will be determined before the procedure and at 4 months will be re-evaluated.
The degree of grip strength changes , after the cryoneurolysis
any changes in Grip strength as a general indicator for functional health care outcome will be measured using Jamar handheld dynamometer.
Measured: Measurement will be done at baseline, 1 week , 1 and 4 months after the procedure.
The degree of functional independence score changes after the cryoneurolysis, in compare to baseline.
any changes in functional independence will be measured using Functional Independence Measure (FIM) questionnaire. Only the motor subscale will be used for this project.
Measured: The questionnaire will be filled out at baseline and in 1 and 4 months after the procedure.
any changes in 10-meter-walk-test
to evaluate any changes in walking speed of patients who have had the procedure for knee 10-meter-walk -test will be used. The result will be recorded in seconds.
Measured: The test will be done at baseline , 1 week and 1 and 4 month follow up.
Any changes in timed up and go test
to assess any changes in mobility of patients who have had the procedure for knee, the time taken to stand from a chair, walk 3 meters, turn and walk back to the chair will be measured in second.
Measured: The test will be done before the procedure and in 1 week and 1 and 4 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start10 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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
- 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
- Principal investigator, Mahdis Hashemi, Vancouver Island Health Authority
- Investigators
- Paul Winston, MD, Principal investigator, Vancouver Island Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674604
- Sponsor's protocol ID
- H22-00564
- Status last verified
- Jun 2024
- First submitted
- 9 Dec 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adey-Wakeling Z, Arima H, Crotty M, Leyden J, Kleinig T, Anderson CS, Newbury J; SEARCH Study Collaborative. Incidence and associations of hemiplegic shoulder pain poststroke: prospective population-based study. Arch Phys Med Rehabil. 2015 Feb;96(2):241-247.e1. doi: 10.1016/j.apmr.2014.09.007. Epub 2014 Sep 28.
PubMed 25264111Allen ZA, Shanahan EM, Crotty M. Does suprascapular nerve block reduce shoulder pain following stroke: a double-blind randomised controlled trial with masked outcome assessment. BMC Neurol. 2010 Sep 21;10:83. doi: 10.1186/1471-2377-10-83.
PubMed 20854696Ratnasabapathy Y, Broad J, Baskett J, Pledger M, Marshall J, Bonita R. Shoulder pain in people with a stroke: a population-based study. Clin Rehabil. 2003 May;17(3):304-11. doi: 10.1191/0269215503cr612oa.
PubMed 12735538Picelli A, Bonazza S, Lobba D, Parolini M, Martini A, Chemello E, Gandolfi M, Polati E, Smania N, Schweiger V. Suprascapular nerve block for the treatment of hemiplegic shoulder pain in patients with long-term chronic stroke: a pilot study. Neurol Sci. 2017 Sep;38(9):1697-1701. doi: 10.1007/s10072-017-3057-8. Epub 2017 Jul 11.
PubMed 28699104Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis providing postoperative analgesia lasting many weeks following a single administration: a replacement for continuous peripheral nerve blocks?: a case report. Korean J Anesthesiol. 2017 Oct;70(5):567-570. doi: 10.4097/kjae.2017.70.5.567. Epub 2017 Feb 3.
PubMed 29046778Zorowitz RD, Gillard PJ, Brainin M. Poststroke spasticity: sequelae and burden on stroke survivors and caregivers. Neurology. 2013 Jan 15;80(3 Suppl 2):S45-52. doi: 10.1212/WNL.0b013e3182764c86.
PubMed 23319485Kwah LK, Harvey LA, Diong JH, Herbert RD. Half of the adults who present to hospital with stroke develop at least one contracture within six months: an observational study. J Physiother. 2012;58(1):41-7. doi: 10.1016/S1836-9553(12)70071-1.
PubMed 22341381Ada L, O'Dwyer N, O'Neill E. Relation between spasticity, weakness and contracture of the elbow flexors and upper limb activity after stroke: an observational study. Disabil Rehabil. 2006 Jul 15-30;28(13-14):891-7. doi: 10.1080/09638280500535165.
PubMed 16777777Harvey LA, Katalinic OM, Herbert RD, Moseley AM, Lannin NA, Schurr K. Stretch for the treatment and prevention of contracture: an abridged republication of a Cochrane Systematic Review. J Physiother. 2017 Apr;63(2):67-75. doi: 10.1016/j.jphys.2017.02.014. Epub 2017 Mar 14.
PubMed 28433236Namdari S, Alosh H, Baldwin K, Mehta S, Keenan MA. Shoulder tenotomies to improve passive motion and relieve pain in patients with spastic hemiplegia after upper motor neuron injury. J Shoulder Elbow Surg. 2011 Jul;20(5):802-6. doi: 10.1016/j.jse.2010.10.023. Epub 2011 Jan 13.
PubMed 21232986Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec.
PubMed 33543059Rubenstein J, Harvey AW, Vincent D, Winston P. Cryoneurotomy to Reduce Spasticity and Improve Range of Motion in Spastic Flexed Elbow: A Visual Vignette. Am J Phys Med Rehabil. 2021 May 1;100(5):e65. doi: 10.1097/PHM.0000000000001624. No abstract available.
PubMed 33105153Winston P, Hashemi M, Vincent D. Ultrasound With E-Stimulation Diagnostic Nerve Blocks for Targeted Muscle Selection in Spasticity. Am J Phys Med Rehabil. 2021 Nov 1;100(11):e167. doi: 10.1097/PHM.0000000000001801. No abstract available.
PubMed 34673709Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016 Aug;13(8):713-25. doi: 10.1080/17434440.2016.1204229. Epub 2016 Jul 13.
PubMed 27333989Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
PubMed 16880882
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoneurolysis as a Drug Free Novel Treatment for Knee and Shoulder Pain Impairing Inpatient Neurological Rehabilitation
- ClinicalTrials.gov ID
- NCT05674604
- Acronym / sponsor ID
- H22-00564
- Conditions
- Shoulder Pain, Knee Pain, Spasticity, Pain, Acute Stroke
- Keywords
- Cryoneurolysis, shoulder pain, knee pain, spasticity, acute stroke, In-patient setting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vancouver Island Health AuthorityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Jan 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.
The purpose of the study is to measure the outcomes of a standard care, an ultrasound guided mini-invasive percutaneous procedure, performed on recent stroke patients on reduces pain, increases function \& quality of life
The primary objective of the project is to reduce shoulder and/or knee pain in patients who have had a stroke so that they can more readily engage in rehabilitation.
Secondary objectives are to reduce analgesic medications, increase independence and improve range of motion, to promote non-drug treatment measures in the medical toolkit, and to include an interdisciplinary care team in patient selection for interventions.
Detailed description
Hemiplegic shoulder pain (HSP) is the most common pain disorder after stroke and one of the four most common complications. The estimated incidence ranges from of 30%-70%. HSP is associated with reductions in function, interference with rehabilitation efforts , and a reduced quality of life .Onset of HSP is rapid, occurring as soon as a week after stroke in 17% of patients.While ubiquitous, the management of HSP represents a complex treatment pathway that has insufficient evidence supporting one particular treatment.
The pain associated with HSP may be due to heterogeneous causes. In the acute setting, decreased ROM in the shoulder may represent several processes including the early onset of spasticity, capsular pattern stiffness, glenohumeral pathology, or a component of complex regional pain syndrome (CRPS). Effective management of the HSP with decreased ROM requires assessment of each possible contributor. The suprascapular nerve provides up to 70% of the sensory fibers to the shoulder. Targeting the suprascapular nerve to reduce pain from stroke has been study with both nerve blocks and radiofrequency ablation. Cryoneurolysis to treat shoulder pain has also been proposed in recent years.
The lack of early recognition and treatment of HSP can lead to worsening limb function, increased pain, and may impair the rehabilitation and recovery process Early intervention may reduce the risk and onset of contracture, which can lead to significant impairments and a reduced quality of life. The incidence of developing at least one contracture in stroke patients within six months of their stroke is estimated at 52%.Contractures are a source of pain and limited ROM, and limit function while stretching has not been shown to be clinically effective. Patients with contractures and limited volitional control of their shoulder muscles, can experience maceration, skin dehiscence, impaired hygiene, and difficulty dressing, thus more invasive surgery may be required.
Knee osteoarthritis is ubiquitous in the aging population. Many stroke patients may have been pre-stroke poor candidates for a total knee arthroplasty due to medical frailty. Participants recovering from stroke, with pre-existing arthritis perceived that their arthritis "held them back" from an expected stroke recovery trajectory.In this study; "This slowed stroke recovery was attributed to daily pain, frustration, mobility limitations, and the required extra coping due to arthritis. As a result, comorbid arthritis increased the complexity of stroke recovery and rehabilitation."
This group has been global pioneers in the use of cryoneurolysis to treat spasticity.The process first involves isolating the nerves with ultrasound guidance and e-stimulation for motor nerves. A diagnostic nerve block is then performed to assess if spasticity is reduced, and range of motion and ease of movement occurs, as well as pain reduction. After a successful nerve block the patient then goes on to have cryoneurolysis which is performed using a small 1.2 to 1.3 mm diameter cryoprobe that is inserted percutaneously to targeted peripheral nerves. It has an established history over more than fifty years for lasting pain relief from months to years, when used for sensory nerves. Cryoneurolysis is possible due to the process of throttling a gas through an orifice from high to low pressure resulting in a rapid expansion of the gas and a drop in temperature, known as the Joule-Thomson effect. The rapid cooling generates an ice ball or oval between 3.5 and 18 mm that is formed at the tip of the with compressed CO2 or N2O at temperatures typically between -60 to -88° C. The ball or oval creates a targeted zone of axon and myelin disruption. This results in loss of axon continuity due to Wallerian degeneration of the targeted nerve extending outward from the lesion over a limited distance. However, the basal lamina, epineurium and perineurium of the targeted nerve remain intact and serve as a conduit or tube for neural regeneration.
Development of the ViVe algorithm to create a team based assessment tool to isolate the sources of Hemiplegic pain. This allows us to select patient that would benefit from cryoneurolysis to both the suprascapular nerve as well as the nerves to the spasticity muscles of the upper limb. Similarly, cryoneurolysis has been shown to be effective in managing osteoarthritis, a limiting factor for stroke rehabilitation.
There are 50,000 new strokes in Canada every year. Direct costs for 12-month stroke survivors are 4 times higher than direct costs for patients with stroke without spasticity during the first year after the event.
It has been demonstrating that cryoneurolysis has long lasting effects Over 100 patients, mostly with chronic neurologic disorders, received cryoneurolysis as a part of their standard care in this center and their outcomes are being measured and assessed . The number of these patients exceeding rapidly and it is essential to assess treating patients much earlier, in acute phase, to assess the reduction in pain, disability, and lengths of stay.
PURPOSE The purpose of this study is to measure the outcomes of a standard care procedure called cryoneurolysis. This will include any changes in pain and spasticity in an inpatient setting and for adult patients with an acute neurological condition who suffer from Hemiplegic Shoulder Pain (HSP) and or osteoarthritis of the knee and will receive this procedure as a part of their treatment and based on available guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Procedure: CryoneurolysisAdult inpatients who are referred to Victoria General Hospital for rehabilitation with the chief complaint of an acute neurological disorder such as stroke, within next 16 weeks, and suffer from shoulder and/or knee pain. All potential participants are already candidate for cryoneurolysis to mange their shoulder or knee pain. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with an acute neurological disorder, within 16 weeks, who have been referred to the Victoria General Hospital for rehabilitation and are already candidate for cryoneurolysis to manage their shoulder and/or knee pain.
Key inclusion criteria (7 listed)
- Adult inpatients at any hospital in the Greater Victoria Area or referred to Victoria General hospital for rehabilitation with the chief complaint of an acute neurological condition (within sixteen weeks) including but not limited to stroke and traumatic brain injury. People that have had a stroke or neurological event within sixteen weeks but have been discharged to outpatient rehab at Victoria General Hospital are also candidates
- In addition to their chief complaint, are also affected by one or both of the following
- Patients who are already candidate for cryoneurolysis.
- Ability to attend testing sessions, comply with testing protocols and provide either written or verbal informed consent. If necessary, a witness will be asked to sign the consent form and confirm the participant signature. For those patients who do not have the capacity to sign the consent form(Based on evaluation by PI or the recorded assessment by their physician in their medical charts) the designated care provider or family member will be asked to sign the ICF on behalf of them. Evaluation of the capacity to understand and communicate are part of routine assessment and are done routinely and each visit by physicians.
- Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
Key exclusion criteria (2 listed)
- Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity or pain. Relevant treatments included but not limited to previous cryoneurolysis, previous chemical neurolysis, neurectomy or arthroplasty.
- Patients who received botulinum toxin in the past 4 months in the same targeted muscles for cryoneurolysis
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 |
|---|---|---|
| CryoneurolysisThis is on observational study. All participants are already candidate for cryoneurolysis. Cryoneurolysis uses a cold probe to generate an ice ball, which initiates Wallerian Degeneration, a process where axon is destroyed but the epineurium and perineurium remain intact. The treated nerve is able to regenerate over time due to this preserved tube. | Procedure or surgery | Participants |
Primary outcome
to determine any changes in shoulder pain, after the cryoneurolysis.
Time frame: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
To do the assessment a questionnaire, Shoulder Pain and Disability Index (SPADI), will be used. This self-administered questionnaire consists of 2 dimensions, one for pain and the other for functional activities with total of 13 questions. Each question is scored on scale of 0 to 10 (0=no pain or difficulty and 10= the worst pain and the most difficulty). The higher total score is equal to more pain and more difficulty in doing the mentioned tasks.
to determine any changes in shoulder pain, based on physician's assessment, after the cryoneurolysis.
Time frame: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
To do the assessment a pain assessment scale named SAAPS (Spasticity- Associated Arm Pain Scale) will be used. The SAAPS collects data on the verbal/ physiological response to passive range of motion (ROM) in five arm segments . The intensity of pain will be scored from 0 (no pain) to 3 (immediate pain on movement). The sum score ranges from 0 to 15, while the higher score is indicative of more pain.
to determine any changes in knee pain, after the cryoneurolysis
Time frame: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.
To score the pain intensity a questionnaire named WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)will be used. The questionnaire has 24 questions about pain, stiffness and physical function. Each question will be scored from 0 (no difficulty or pain ) to 4 (extreme pain and difficulty). Total score will be calculated out of 100 and higher score presents the worst pain and difficulty.
the degree of range of motion changes after the cryoneurolysis.
Time frame: The assessment will be done before and 1 week, 1 and 4 months after the procedure.
to evaluate any changes in shoulder and knee passive and active range of motion after the procedure. The range will be measured by goniometer and will be shown in degrees. The higher degree presents , more range of motion.
The degree of changes in targeted muscles tone.
Time frame: The assessment will be done before and 1 week, 1 and 4 months after the procedure.
to evaluate any changes in shoulder and knee tone after the procedure. The assessment will be done during shoulder abduction, flexion, external rotation and knee flexion passive movement.The tone will be scored based on Modified Ashworth Scale, from 0 to 4. (0= no tone, 4 = maximum tone)
5 secondary outcomes
Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale (Turner-Stokes, 2009)
Time frame: Goals will be determined before the procedure and at 4 months will be re-evaluated.
The degree of grip strength changes , after the cryoneurolysis
Time frame: Measurement will be done at baseline, 1 week , 1 and 4 months after the procedure.
The degree of functional independence score changes after the cryoneurolysis, in compare to baseline.
Time frame: The questionnaire will be filled out at baseline and in 1 and 4 months after the procedure.
any changes in 10-meter-walk-test
Time frame: The test will be done at baseline , 1 week and 1 and 4 month follow up.
Any changes in timed up and go test
Time frame: The test will be done before the procedure and in 1 week and 1 and 4 months after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 25264111Adey-Wakeling Z, Arima H, Crotty M, Leyden J, Kleinig T, Anderson CS, Newbury J; SEARCH Study Collaborative. Incidence and associations of hemiplegic shoulder pain poststroke: prospective population-based study. Arch Phys Med Rehabil. 2015 Feb;96(2):241-247.e1. doi: 10.1016/j.apmr.2014.09.007. Epub 2014 Sep 28.
- Background: PubMed 20854696Allen ZA, Shanahan EM, Crotty M. Does suprascapular nerve block reduce shoulder pain following stroke: a double-blind randomised controlled trial with masked outcome assessment. BMC Neurol. 2010 Sep 21;10:83. doi: 10.1186/1471-2377-10-83.
- Background: PubMed 12735538Ratnasabapathy Y, Broad J, Baskett J, Pledger M, Marshall J, Bonita R. Shoulder pain in people with a stroke: a population-based study. Clin Rehabil. 2003 May;17(3):304-11. doi: 10.1191/0269215503cr612oa.
- Background: PubMed 28699104Picelli A, Bonazza S, Lobba D, Parolini M, Martini A, Chemello E, Gandolfi M, Polati E, Smania N, Schweiger V. Suprascapular nerve block for the treatment of hemiplegic shoulder pain in patients with long-term chronic stroke: a pilot study. Neurol Sci. 2017 Sep;38(9):1697-1701. doi: 10.1007/s10072-017-3057-8. Epub 2017 Jul 11.
- Background: PubMed 29046778Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis providing postoperative analgesia lasting many weeks following a single administration: a replacement for continuous peripheral nerve blocks?: a case report. Korean J Anesthesiol. 2017 Oct;70(5):567-570. doi: 10.4097/kjae.2017.70.5.567. Epub 2017 Feb 3.
- Background: PubMed 23319485Zorowitz RD, Gillard PJ, Brainin M. Poststroke spasticity: sequelae and burden on stroke survivors and caregivers. Neurology. 2013 Jan 15;80(3 Suppl 2):S45-52. doi: 10.1212/WNL.0b013e3182764c86.
- Background: PubMed 22341381Kwah LK, Harvey LA, Diong JH, Herbert RD. Half of the adults who present to hospital with stroke develop at least one contracture within six months: an observational study. J Physiother. 2012;58(1):41-7. doi: 10.1016/S1836-9553(12)70071-1.
- Background: PubMed 16777777Ada L, O'Dwyer N, O'Neill E. Relation between spasticity, weakness and contracture of the elbow flexors and upper limb activity after stroke: an observational study. Disabil Rehabil. 2006 Jul 15-30;28(13-14):891-7. doi: 10.1080/09638280500535165.
- Background: PubMed 28433236Harvey LA, Katalinic OM, Herbert RD, Moseley AM, Lannin NA, Schurr K. Stretch for the treatment and prevention of contracture: an abridged republication of a Cochrane Systematic Review. J Physiother. 2017 Apr;63(2):67-75. doi: 10.1016/j.jphys.2017.02.014. Epub 2017 Mar 14.
- Background: PubMed 21232986Namdari S, Alosh H, Baldwin K, Mehta S, Keenan MA. Shoulder tenotomies to improve passive motion and relieve pain in patients with spastic hemiplegia after upper motor neuron injury. J Shoulder Elbow Surg. 2011 Jul;20(5):802-6. doi: 10.1016/j.jse.2010.10.023. Epub 2011 Jan 13.
- Background: PubMed 33543059Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec.
- Background: PubMed 33105153Rubenstein J, Harvey AW, Vincent D, Winston P. Cryoneurotomy to Reduce Spasticity and Improve Range of Motion in Spastic Flexed Elbow: A Visual Vignette. Am J Phys Med Rehabil. 2021 May 1;100(5):e65. doi: 10.1097/PHM.0000000000001624. No abstract available.
- 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. This study is not recruiting at the moment.
Paul Winston, MD principal investigator
Vancouver Island Health Authority
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 Shoulder Pain and Knee Pain, 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 7 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 14 Jun 2024. 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?
to determine any changes in shoulder pain, after the cryoneurolysis. (time frame: The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.). The study lists 5 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 NCT05674604, which also lists 19 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 14 Jun 2024.