Clinical trial NCT03910101: Long-term Efficacy of Spasticity-correcting Surgery and Botulinum Toxin Injections for Upper Limb Spasticity Treatment
Official title: Long-term Efficacy of Spasticity-correcting Surgery and Botulinum Toxin Injections for Upper Limb Spasticity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity, Muscle
Spinal Cord Injuries
Traumatic Brain Injury
Stroke
Upper Extremity Paresis
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2019-04-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spasticity - a variety of motor over-activity and part of the upper motor neuron syndrome - is a common cause of impaired motor function after brain injuries of different etiologies. In addition, it may cause pain and impaired hygiene, contractures, deformities etc. Spasticity has been reported in 30 to 90% of patients with stroke, traumatic brain injury (TBI), incomplete spinal cord injury (SCI) and cerebral palsy (CP).

Spasticity therapy has emerged as an important approach to alleviate related symptoms. Positive effects on spasticity are well recognized following systemic and intra-thecal pharmacological treatment, as well as after intra-muscularly injected substances; the effect of the latter is, however, of limited duration. While pharmacological spasticity therapy has been applied for decades, surgical procedures remain fairly uncommon in adults with spasticity, but not in pediatric patients with CP, and outcomes after surgical treatment are scarcely described in the literature.

The study center is a specialized unit initially focused on reconstructive as well as spasticity reducing surgery in the upper extremities for SCI patients. Subsequently, patients with spasticity also due to various other Central nervous system diseases have been referred to the center for surgical treatment. Studies describing the effect of spasticity-reducing surgery in the upper extremities are rare and the group is heterogeneous. The aim of the study is evaluating the long-term efficacy of spasticity-correcting surgery versus BoNT in patients with disabling UL spasticity. As a secondary aim, we want to compare the peak effects of the two treatments, Botulinum toxin injections and spasticity-correcting surgery.

Detailed description: Study design and participants This study used a pretest-posttest quasi-experimental design.

Study participants are recruited using two parallel procedures. I) Review of a hospital-based register of patients who had been treated or referred to the tonus clinic identified eligible patients, who were then sent information about the study, along with their contact information to the researcher responsible for the study. II) Patients with ongoing BoNT treatment who had been referred to the Center for Advanced Reconstruction of Extremities (C.A.R.E.), and were eligible for the present study were informed about the study and enrolment procedure.

All presumptive study participants will undergo a screening procedure by the primary examiner, to assess whether they met the study's eligibility criteria. Written informed consent will be obtained if the patient met the inclusion criteria and consented to participate. All patients are offered either of the two treatment methods, the treatment allocation are based on individual preferences. The study will be conducted in accordance with relevant ethical guidelines (Declaration of Helsinki).

The primary outcome measure are muscle tone, measured using the Modified Ashworth Scale (MAS). The single-item MAS was measured on a six-point scale from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with an additional point allocated at 1+ (slight increase in muscle tone). As such, the MAS provides a single score to represent spasticity in a specific movement. For analysis, the MAS scores of the treated muscles were summed to obtain a "composite spasticity score" for each participant.

Secondary outcomes includes measures within, body function, activity and Participation.

The calculation of sample size was based on the a priori defined difference to be detected, with an alpha level of 5% and a power goal of 80%, as well as the primary outcome variable MAS and previous findings. Provide a number of 14 participants in each of the two groups. We expected a dropout rate of 15%, and therefore aimed to include 17 individuals in each group to achieve 80% power.

Between-group differences and within-group differences in treatment efficacy will be analysed by comparing pretest-posttest changes.

Eligibility criteria: The eligibility criteria for this study were as follows: 1. 18 years or above; 2. Problematic spasticity, characterised by a velocity-dependent increase in tonic stretch reflexes or intermittent or sustained involuntary muscle activity in the UL after stroke, TBI, or SCI; and 3. Patients treated at least 6 months after the injury event; and 4. Ongoing BoNT treatment in the UL, 5. A minimum of 3 months passed since the last BoNT injection: 6. At least two muscles in the hand and wrist were considered for treatment 7. For the BoNT group, a community occupational or physical therapist was assigned for post BoNT treatment; 8. For the surgery group, medically stable to undergo surgery; 9. No other severe UL injuries affecting the functional level.

Exclusion Criteria:

* Under the age of 18

Primary outcomes:
measure: Change is being assessed with Modified Ashworth Scale
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
Secondary outcomes:
measure: Change is being assessed with Visual Analog scale (VAS)
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with goniometry
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with Jamar dynamometer
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with pinch gauge
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with opening of the hand passive, Active and resting position
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with The Canadian Occupational Performance Measure (COPM)
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with Grasp and Release Test (GRT)
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with Arm Activity Measure (ArmA)
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with Cylinder test
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
measure: Change is being assessed with Functional score
timeFrame: Change from baseline and at the the time points 4-6weeks and 6months
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Sahlgrenska University Hospital, centrum for advanced reconstruction of extremities
state: Västra Götaland
Study officials:
affiliation: University of Gothenburg, Sahlgrenska academy
name: Lina Bunketorp Kall, PhD
role: STUDY_CHAIR
References: