Effect of Cryoneurolysis on Pain in Patients With Hand Contracture.

NCT06051656 | Unknown

• 1 other identifier: H22-03181
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Contracture; Spasticity, Muscle

Keywords

Wrist contracture; Severe spasticity; Pain; Cryoneurolysis; Hand contracture

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  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 assessment will be done at baseline, 2 weeks, one and four months after the procedure.

• Any changes in hand hygiene will be recorded.

  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.

  The assessment will be done at baseline and at 4 months.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vancouver Island Health Authority: lead

Study Sites (1)

Victoria General Hospital

Victoria, British Columbia, V8Z 6R5, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 18332384 BACKGROUND

• Diong 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.

  PMID: 22450888 BACKGROUND

• Matozinho 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.

  PMID: 31328966 BACKGROUND

• Schnitzler 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.

  PMID: 26797076 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

MeSH Terms

Conditions

Contracture; Muscle Spasticity; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Winston, MD

  Vancouver Island Health

  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: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: September 25, 2023
• Study Start: January 9, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

CA (1)