Surgery and Neuroablative Procedures in Spasticity

NCT ID: NCT04670783

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2023-05-30

Brief Summary

For many patients with spasticity, traditional therapies have not achieved maximal outcomes. Due to common complaints such as pain, limb positioning and hygiene concerns, there has been an increase demand for other adjunctive therapies like surgeries and other interventions. This spasticity multidisciplinary clinic consisting of a physiatrist, plastic surgeon and anesthesiologist is performing a novel approach to refractory spasticity to triage and designed a treatment plan for them as routine medical care. This study will document the efficacy of this novel designed multidisciplinary approaches for intervention in complex spasticity patients, and will develop a decision-making algorithm in spasticity including both traditional treatment (i.e. botulinum toxin , bracing) and novel treatments(i.e. neurectomy , cryoneurotomy).

Detailed Description

Many patients continue to live with disabling spasticity that negatively affects their health, independence and quality of life. For these patients, traditional therapies such as bracing, medications, and botulinum toxin have not achieved maximal outcomes. Up to one-quarter of physicians have noted to be limited by the maximal dosage of botulinum toxin allowed in their country. Due to common complaints of pain, difficulty with limb positioning, and hygiene concerns there has been an increase in demand for novel adjunctive therapies, including surgery, to improve patient outcomes.

The deisgned triage pathway is based on the diagnostic lidocaine nerve block (DNB), which is already using in Franco-European studies and has been accepted as academic abstract at the Canadian Association of Physical Medicine and Rehabilitation Annual Meeting in Gatineau Quebec in 2019. In this approach, patients are triaged for intervention based on their responses to DNB, which is applying local anesthesia to a selected nerve branch. Also the investigators of this study who have created Canada's first interdisciplinary spasticity clinic consisting of a physiatrist, plastic surgeon and anesthesiologist are working to bring the world-leading spasticity interventions to Canada and developing Canadian techniques. This includes cryoneurotomy and selective microfascicular neurectomy. Both of these techniques have been developed in this multidisciplinary clinic and in the past three years and have been published as journal articles, academic posters or presented at international congresses.This research is a pilot study to test the present current triage and treatment pathways. This study will evaluate the patients with upper limb spasticity who are going to have any of traditional treatments (i.e. bracing, botulinum toxin) or novel treatments (i.e. cryoneurotomy, tenotomy, neurotomy) as their standard medical cares. All these assessments are parts of their standard evaluations and the available data will be collected for this study. These data include their range of motions, spasticity grades, upper limb function, pain, satisfaction and injected botulinum toxin dosage. These data will be used to document the efficacy of this approach by comparing these measurements that are already done for their standard clinical care. Also, the final result will be helpful to create a Canadian algorithm to approach patients with refractory upper limb spasticity.

Conditions

Upper Extermity Spasticity; Multidisciplinary Approach; Novel Algorithm; Diagnostic Nerve Block; Surgery; Percutaneous Neuroablative Procedures; Refractory Spasticity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Surgery

Orthopedic surgery (i.e. tenotomy, tendon transfer) or percutaneous neuroablative procedures (i.e. cryoneurotomy) which will be done for upper limb refractory spasticity after being triaged by DNB.

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous neuroablation

Eligibility Criteria

Inclusion Criteria

• Adult patient ≥ 18 years old, with upper extremity spasticity causing functional impairment.
• Patients that have plateaued in outcomes in which the clinical examination suggests further interventions can be trialed.
• The clinical examination, including a V1 (maximal passive stretch) and V3 (Fast catch) on upper extremity examination that demonstrates further passive or active range may be possible, versus if contracture must be managed. For example, a fisted hand that can be forced open. This includes factors such as fluctuating tone or clonus interfering with the assessment.
• The patient undergoes a diagnostic nerve block to determine if there is reducible spasticity in the muscle versus contracture.
• The patient has been offered a neuroablative procedure or surgery and has elected to undergo the procedure. The patient has consented to undergo the said procedure.

Exclusion Criteria

• Patients where no consent or Assent is obtained
• Unable to attend treatment schedule,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vancouver Island Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Mahdis Hashemi

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Winston, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

VIHA

Locations

Victoria General Hospital

Victoria, British Colombia, Canada

Countries

Canada

References

Wissel J, Verrier M, Simpson DM, Charles D, Guinto P, Papapetropoulos S, Sunnerhagen KS. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R. 2015 Jan;7(1):60-7. doi: 10.1016/j.pmrj.2014.08.946. Epub 2014 Aug 27.

Reference Type: BACKGROUND

PMID: 25171879 (View on PubMed)

Bensmail D, Hanschmann A, Wissel J. Satisfaction with botulinum toxin treatment in post-stroke spasticity: results from two cross-sectional surveys (patients and physicians). J Med Econ. 2014 Sep;17(9):618-25. doi: 10.3111/13696998.2014.925462. Epub 2014 Jun 12.

Reference Type: BACKGROUND

PMID: 24841450 (View on PubMed)

Yelnik AP, Hentzen C, Cuvillon P, Allart E, Bonan IV, Boyer FC, Coroian F, Genet F, Honore T, Jousse M, Fletcher D, Velly L, Laffont I; SOFMER group; SFAR group; Viel E. French clinical guidelines for peripheral motor nerve blocks in a PRM setting. Ann Phys Rehabil Med. 2019 Jul;62(4):252-264. doi: 10.1016/j.rehab.2019.06.001. Epub 2019 Jun 13.

Reference Type: BACKGROUND

PMID: 31202956 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33543059 (View on PubMed)

Winston P, Krauss E, Vincent D. Cryoneurotomy of the bilateral lateral pectoral nerves in a quadriplegic patient with spasticity, a novel approach. ISPRM 2020 Poster. 2020.

Reference Type: BACKGROUND

Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

Reference Type: BACKGROUND

PMID: 8773720 (View on PubMed)

House JH, Gwathmey FW, Fidler MO. A dynamic approach to the thumb-in palm deformity in cerebral palsy. J Bone Joint Surg Am. 1981 Feb;63(2):216-25.

Reference Type: BACKGROUND

PMID: 7462278 (View on PubMed)

Winston P, MacRae F, Rajapakshe S, Morrissey I, Boissonnault E, Vincent D, Hashemi M. Analysis of Adverse Effects of Cryoneurolysis for the Treatment of Spasticity. Am J Phys Med Rehabil. 2023 Nov 1;102(11):1008-1013. doi: 10.1097/PHM.0000000000002267. Epub 2023 Apr 24.

Reference Type: DERIVED

PMID: 37104641 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

H2019-03232

Identifier Type: -

Identifier Source: org_study_id