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

Phase 3

Recruiting

• Conditions: Concussion and edema of cervical spinal cord, (2) ICD-10 Condition: S340||Concussion and edema of lumbar andsacral spinal cord, (3) ICD-10 Condition: S240||Concussion and edema of thoracic spinal cord, (4) ICD-10 Condition: S141||Other and unspecified injuries ofcervical spinal cord, (5) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord, (6) ICD-10 Condition: S341||Other and unspecified injury of lumbar and sacral spinal cord,

• Registration Number: CTRI/2022/12/047966
• Lead Sponsor: Bharat Pulavarti

Brief Summary

Spinal cord injury refers to damage to spinal cord resulting from trauma or non-traumatic causes. Components and complications of spinal cord injury eventually place a nagging physical, mental, financial, emotional and rehabilitative burden on the patient and caretakers. To this date, one of the challenging and neglected problems to manage in spinal cord injury has been spasms.

Spasm is defined as a transient but continuous muscular contraction which can be triggered by a combination of cutaneous and/or visceral triggers.

Spasms can interfere with basic functional tasks like eating, grooming, bowel and bladder habits, affect ambulation, pose a challenge to the person administering therapy and become a hindrance in progression of the exercise programmes.

The current pharmacological management of spasms include oral drugs like diazepam, baclofen, clonazepam; and focal injections of botulinum toxin and phenol.

Baclofen is the first line management of spasms in spinal cord injury. Its effects on reducing problematic spasms have been mentioned in studies both orally. However, baclofen has been proved efficacious in 61-72 % of patient with spasms. These figures indicate that up to 40 percent of patients with spasms could potentially go untreated by baclofen.

There is a need of identifying other efficacious drugs in reducing spasms. One such drug, Clonazepam, has been mentioned as a potential therapeutic option for treatment of spasms, its advantage compared to diazepam is the shorter half-life and potentially less sedation.

More studies are needed to quantify clonazepam’s efficacy as a potential drug for reducing spasms.

Studies of this nature are largely done outside India. There is a need for identifying the drugs that are efficacious in an Indian setting.

This study intends to compare the therapeutic efficacy of clonazepam and baclofen for spinal cord injury patients suffering from spasms, in an Indian setting.

The effect of the intervention will be measured using Penn spasm frequency scale and Spinal cord assessment tool for spastic reflexes.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the proportion of patients who benefitted from each intervention.	Final assessment on 31st day after initiation of the intervention.

Trial Locations

Locations (1)

All India Institute of Physical Medicine and Rehabilitation; 🇮🇳 Mumbai, MAHARASHTRA, India

All India Institute of Physical Medicine and Rehabilitation

🇮🇳Mumbai, MAHARASHTRA, India

Bharat Pulavarti

Principal investigator

9513322494

bpulavarti@gmail.com