A comparative study between Spasm relieving medications, Clonazepam and Baclofen given orally in spinal cord injury patients.

A comparative study of the therapeutic efficacy of oral clonazepam and oral baclofen on spasms among patients with spinal cord injury: A randomised controlled trial.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/047966

Enrollment

Registered

2022-12-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S140- Concussion and edema of cervical spinal cord Health Condition 2: S340- Concussion and edema of lumbar andsacral spinal cord Health Condition 3: S240- Concussion and edema of thoracic spinal cord Health Condition 4: S141- Other and unspecified injuries ofcervical spinal cord Health Condition 5: S241- Other and unspecified injuries ofthoracic spinal cord Health Condition 6: S341- Other and unspecified injury of lumbar and sacral spinal cord

Interventions

Intervention1: Clonazepam: Oral Clonazepam (0.25 mg to 1.5 mg per day in up to two divided doses) for a duration of thirty days Control Intervention1: Baclofen: Oral Baclofen (5 mg to 75 mg in up to 3

Eligibility

Inclusion criteria

Inclusion criteria: Spinal cord injury patients in the above age group, suffering from spasms, have sufficient mental capacity to respond relevantly to all queries related to spasms.

Exclusion criteria

Exclusion criteria: Spinal cord injury patients who exhibit spasticity but do not present with spasms. Patients who are pregnant. Patients with narrow angle glaucoma. Patients with history of clinical depression and suicidal tendencies. Patients who are currently on antispastic and anti-spasm medication will not be enrolled in the study. Patients with deranged complete blood count, liver function tests and renal function tests. Patients with pre-existing musculoskeletal disorders and movement disorders in which spasms and spasticity cannot be assessed accurately.

Design outcomes

Primary

Measure	Time frame
Reduction in problematic spasms assessed by Penn spasm frequency and severity scale by at least one grade.Timepoint: The final assessment will be done on the 31st day after the initiation of the intervention	—

Secondary

Measure	Time frame
To determine the proportion of patients who benefitted from each intervention.Timepoint: Final assessment on 31st day after initiation of the intervention.	—

Countries

India

Contacts

Public ContactBharat Pulavarti

All India Institute of Physical Medicine and rehabilitation

dranilgaur@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026