The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI.
The main questions it aims to answer are :
1. Assess the safety of early baclofen treatment during acute care after SCI. 2. Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI, in terms of mobility, global functional independence, neurological recovery, pain and spasticity.
The early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed. The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. The control group however will receive the "usual routine care" at our institution as per which baclofen is initiated by the attending physician (i.e. physiatrist or spine surgeon) only when acute spasticity becomes severe and problematic.
Male or female aged 18 years or older
Blunt (non-penetrating) traumatic SCI
AIS grade A to D
NLI between C0 and L1
Non-traumatic SCI (e.g. tumor, infection, transverse myelitis, etc.)
AIS grade E upon admission
Penetrating tSCI (from stab wound, gunshot injury, etc.)
Cauda equina syndrome or NLI below L1
Parallel
Early baclofen Intervention
DrugBaclofen is initiated as soon as any sign of acute spasticity. 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic.
Usual routine care
DrugBaclofen is initiated only when acute spasticity is deemed problematic. 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response.
Spinal Cord Independence Measure (SCIM)
The primary outcome consists of the mobility subscore from the SCIM 6 months after the SCI with early baclofen treatment when compared to the control group. The SCIM will measure the ability of the 55 SCI patients to perform basic activities of daily living independently. There are 19 items divided into 3 subscales. A total score out of 100 is achieved, with the subscales weighted as follows: 1. self-care: scored 0-20; 2. respiration and sphincter management: scored 0-40; and 3. mobility: scored 0-40 Scores are higher in patients that require less assistance or fewer aids to complete basic activities of daily living and life support activities.
Adverse Events
Adverse events will be collected for both early baclofen treatment and control groups during acute care after SCI.
Spastic reflexe assessment
The Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) will be used to measure spastic reflexes. This will be measured weekly, after hospital discharge and during outpatient follow-up visits 6 weeks and 6 months after the injury. The SCATS is split into 3 subscales, each addressing a seperate spasm. 1\) Clonus 2) Flexor spasms 3) Extensor spasms. For each subscale, the spasm is triggered and then rated. The degree of spasm is rated between 0 (no spasm) to 3 (severe spasm lasting longer than 10 seconds)
Muscle Spasticity assessment
The Modified Ashworth Scale (MAS) will be used to measure spasticity for each muscle assessed. The MAS is a 6-point scale. Scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). This scale also adds a +1 scoring category to indicate resistance through less than half of the movement. Lower scores represent normal muscle tone and higher scores represent spasticity.
Spasticity frequency
The Modified Penn Spasm Frequency Scale (mPSFS) will be used to quantify spasticity. It is a 2 component self-report measure in which the patients will report their perception of spasticity in regards to frequency and severity. The first component is a 5 point scale assessing the frequency with which spasms occur ranging from 0 (No spasms) to 4 (Spontaneous spasms occurring more than ten times per hour) The second component is a 3 point scale assessing the severity of spasms ranging from 1 (Mild) to 3 (Severe). The second component is not answered if the person indicates they have no spasms in part 1.
Spasticity impact
The Patient Reported Impact of Spasticity Measure (PRISM) measures the impact of SCI-related spasticity on quality of life from the patient's perspective. The PRISM consists of 41 items, divided into 7 subscales namely anxiety, psychological agitation, daily activities, assistance, positive impact, need for intervention, social embarrassment. It uses 5 point Likert Scale for scoring, 0 = Never true for me, 1 = Rarely true for me, 3 = Often true for me, 4 = Very often true for me. A higher score is considered unhealthy.
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