Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorVancouver Island Health Authority
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cryoneurolysis
Procedure/SurgeryThis 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Participants1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.2
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.
Time frame
The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.3
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.
Time frame
The measurement will be done at baseline, 1 week, 1 and 4 months after the procedure.4
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.
Time frame
The assessment will be done before and 1 week, 1 and 4 months after the procedure.Secondary outcomes
1
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)
Time frame
Goals will be determined before the procedure and at 4 months will be re-evaluated.2
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.
Time frame
Measurement will be done at baseline, 1 week , 1 and 4 months after the procedure.3
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.
Time frame
The questionnaire will be filled out at baseline and in 1 and 4 months after the procedure.4
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.
Time frame
The test will be done at baseline , 1 week and 1 and 4 month follow up.Sponsors and contacts
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Source ClinicalTrials.gov