Effect of Cryoneurolysis on Pain in Patients With Hand Contracture.

September 28, 2023 updated by: Vancouver Island Health Authority

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8Z 6R5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  1. Adult patients(at least 18 years old).
  2. Severe claw hand with less than 4 cm distance between the pulp of the fingers and palm of the hand.
  3. MAS>= 3 in wrist and hand muscles interfering with function or causing a clinical problem, due to any neurological condition.
  4. Have refractory pain in wrist and hand areas with no response to the usual pain management methods including oral medication or botulinum toxin injection.
  5. 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).
  6. 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.

Exclusion Criteria:

  1. Have undergone any previous peripheral nerve procedures in their affected side, for the treatment of spasticity, including previous cryoneurolysis, chemical neurolysis, neurectomy or arthroplasty.
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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.
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.
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.
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.
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.
The assessment will be done at baseline, 2 weeks, one and four months after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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' 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.
Time Frame: The assessment will be done at baseline and at 4 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vancouver Island Health Authority

Investigators

  • Principal Investigator: Paul Winston, MD, Vancouver Island Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22-03181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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