Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury

Condition(s) studied

Investigational drug(s) / intervention(s)

Early baclofen Intervention: Baclofen 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: Baclofen 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Spinal Cord Independence Measure (SCIM) — 6 months after the injury
  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 — From acute care to 6 months after the injury,
  Adverse events will be collected for both early baclofen treatment and control groups during acute care after SCI.

Trial sites (1)

More Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal trials in Canada