Surgery and Neuroablative Procedures in Spasticity

NCT04670783 | Completed

• 1 other identifier: H2019-03232
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Degree of changes in spasticity as assessed by Modified Ashworth Scale from baseline and in 1, 3, 6, 9 and 12 months after the intervention.

  The test will be done by the trained assistant which is not enrolled in providing medical care. The scale has 5 grades and based on severity of spasticity the examiner will assign a number to each tested movement. The grades are shown as 0, 1, 1+, 2, 3, 4. In grade 0 patient shows no spasticity , while grade 4 means maximum spasticity and the affected limb is rigid in flexion or extention.

  up to 12 months after intervention

• Degree of changes in range of motion of tested joints as assessed by Tardieu Scale from base line and in 1, 3, 6, 9 and 12 months.

  The maximum of passive range of motion in slow movement(V1) and degree of catch in speed (V3) and active range of motion will be measured by goniometer.

  up to 12 months

• Upper limb function changes as assessed by Disabilities of the Arm, Shoulder and Hand questionnaire ( DASH questionnaire)(2006).

  It is a self-administered questionnaire that participants will be asked to fill out at baseline and in 1, 3, 6, 9 and 12 months. Final score will be calculated based on the provided formula and will be between (0) , which means patient has no difficulty at all and (100) which means the worst outcome.

  up to 12 months

• Patients satisfaction in achieving their goals after the procedure as assessed by Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale.

  Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale38. Based on this scale participants will be asked for 3 main goals that they desire to achieve after the intervention. The baseline score will be (-1) and they will be interviewed again at 1, 3, 6, 9 and 12 months, to record how they reported their achievement. The scores of (-2), (-0.5), (0), (+1) and (+2) will be assigned if they feel that their condition is worst 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, in each session. The higher score is presenting of better outcome

  up to 12 months after procedure

Secondary Outcomes (6)

• Upper limb function changes as assessed by Box and Block test.

  up to 12 months after procedure.

• Changes in pain as assessed by Brief Pain Inventory Questionnaire.

  up to 12 months

• Changes in hand resting position as assessed by Keenan Scale. (the name of the physician that first described that in 1987)

  12 months after intervention

• Changes in thumb position as assessed by House Scale (The name of physician that first described this classification in 1981).

  12 months after the procedure

• Changes in hand function as assessed by House Functional Scale ( the name of the physician that first described this scale in 1981).

  up to 12 months after intervention

Interventions

Surgery PROCEDURE

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.

Also known as: Percutaneous neuroablation

Eligibility Criteria

• Age: 18 Years - 70 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 upper limb spasticity who has been triaged to have surgery or neuroablative procedure after undergoing a successful DNB.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vancouver Island Health Authority: lead

Study Sites (1)

Victoria General Hospital

Victoria, British Colombia, V8Z 6R5, Canada

Location

Related Publications (8)

• 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.

  PMID: 25171879 BACKGROUND

• 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.

  PMID: 24841450 BACKGROUND

• 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.

  PMID: 31202956 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

• 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.

  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.

  PMID: 8773720 BACKGROUND

• 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.

  PMID: 7462278 BACKGROUND

• 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.

  PMID: 37104641 DERIVED

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul Winston, MD FRCPC

  VIHA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 17, 2020
• Study Start: September 15, 2020
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)