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Botulinum Toxin for Treating Low Back Pain

Efficacy of Botulinum Toxin Type A for Treating Chronic Low Back Pain–A single blinded randomized study - BOTOX

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044530
Enrollment
44
Registered
2022-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: M519- Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder

Interventions

Intervention1: BoNT-A: The BoNT-A will be re-constituted using frozen-dried toxin and mixed with normal saline to a concentration of 100 Ipsen units/mL. The mixture will be drawn into a 2-mL syringe.

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with chronic low back pain > 3 months 2. Without red flags (history suggestive of tumor, trauma, infection, malignancy or cauda equina syndrome), 3.Aged between 18-60 years 4. Willing to participate • Will be investigated with calcium, Vit D and X rays

Exclusion criteria

Exclusion criteria: • Acute low back pain, • Known systemic disorders, • Spinal deformities • Neuromuscular weakness • Malignancy • Bleeding disorders • History of back surgeries • Known allergies to the BoNT-A

Design outcomes

Primary

MeasureTime frame
To assess pain reduction with injection BoNT-A in CLBP at end of 8weeksTimepoint: 8 weeks

Secondary

MeasureTime frame
To assess disability reduction with injection BoNT-A in CLBP at end of 8weeksTimepoint: 8 weeks

Countries

India

Contacts

Public Contactmantu jain

AIIMS bhubaneswar

montu_jn@yahoo.com09090471731

Outcome results

None listed

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