Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting

NCT05674604 | Recruiting

• 1 other identifier: H22-00564
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Shoulder Pain; Knee Pain; Spasticity; Pain; Acute Stroke

Keywords

Cryoneurolysis; shoulder pain; knee pain; spasticity; acute stroke; In-patient setting

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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)

  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)

  Goals will be determined before the procedure and at 4 months will be re-evaluated.

• The degree of grip strength changes , after the cryoneurolysis

  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.

  The questionnaire will be filled out at baseline and in 1 and 4 months after the procedure.

• any changes in 10-meter-walk-test

  The test will be done at baseline , 1 week and 1 and 4 month follow up.

• Any changes in timed up and go test

  The test will be done before the procedure and in 1 week and 1 and 4 months after the procedure.

Study Arms (1)

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.

Procedure: Cryoneurolysis

Interventions

Cryoneurolysis PROCEDURE

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.

Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Vancouver Island Health Authority: lead

Study Sites (1)

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

RECRUITING

Related Publications (19)

• 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.

  PMID: 25264111 BACKGROUND

• Allen 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.

  PMID: 20854696 BACKGROUND

• Ratnasabapathy 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.

  PMID: 12735538 BACKGROUND

• Picelli 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.

  PMID: 28699104 BACKGROUND

• Ilfeld 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.

  PMID: 29046778 BACKGROUND

• Zorowitz 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.

  PMID: 23319485 BACKGROUND

• Kwah 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.

  PMID: 22341381 BACKGROUND

• Ada 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.

  PMID: 16777777 BACKGROUND

• Harvey 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.

  PMID: 28433236 BACKGROUND

• Namdari 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.

  PMID: 21232986 BACKGROUND

• Winston 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.

  PMID: 33543059 BACKGROUND

• Rubenstein 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.

  PMID: 33105153 BACKGROUND

• Winston 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.

  PMID: 34673709 BACKGROUND

• Ilfeld 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.

  PMID: 27333989 BACKGROUND

• Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.

  PMID: 16880882 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.

  PMID: 29121277 BACKGROUND

• Hsu M, Stevenson FF. Wallerian degeneration and recovery of motor nerves after multiple focused cold therapies. Muscle Nerve. 2015 Feb;51(2):268-75. doi: 10.1002/mus.24306. Epub 2014 Dec 23.

  PMID: 24895229 BACKGROUND

• Fitterer JW, Picelli A, Winston P. A Novel Approach to New-Onset Hemiplegic Shoulder Pain With Decreased Range of Motion Using Targeted Diagnostic Nerve Blocks: The ViVe Algorithm. Front Neurol. 2021 May 28;12:668370. doi: 10.3389/fneur.2021.668370. eCollection 2021.

  PMID: 34122312 BACKGROUND

• Lundstrom E, Smits A, Borg J, Terent A. Four-fold increase in direct costs of stroke survivors with spasticity compared with stroke survivors without spasticity: the first year after the event. Stroke. 2010 Feb;41(2):319-24. doi: 10.1161/STROKEAHA.109.558619. Epub 2009 Dec 31.

  PMID: 20044535 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Muscle Spasticity; Pain; Stroke

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paul Winston, MD

  Vancouver Island Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahdis Hashemi, MD

CONTACT

250-727-4233; mahdis.hashemi@islandhealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordiantor

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 6, 2023
• Study Start: October 10, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)