A Trial to compare the effect of two drug combinations Tolperisone with Etodolac and Thiocolchicoside with Etodolac in patients with low back pain and muscle spasm

A Comparative study on safety and efficacy of Tolperisone with Etodolac and Thiocolchicoside with Etodolac in acute musculoskeletal spasm associated with low back pain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/11/003159

Enrollment

200

Registered

2012-11-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Acute muscle spasm with low back pain

Interventions

Intervention1: Tolperisone with Etodolac: Tolperisone 150mg and Etodolac 400mg twice a day for 7 days orally Control Intervention1: Thiocolchicoside with Etodolac: Thiocolchicoside 4mg and Etodolac 40

Eligibility

Inclusion criteria

Inclusion criteria: Patients with acute musculoskeletal spasm with low back pain due to Lumbar spondylosis, osteoarthritis, Acute lumbosacral strain, Blunt superficial trauma, prolapsed intervertebral disc Patients who are ready to give written informed consent and comply with the protocol requirements Patients who are willing to take medications as directed and come for the follow up

Exclusion criteria

Exclusion criteria: Patients with acute muscle spasms who need parenteral therapy, surgery or hospital admissions for management. Pregnant or lactating women. Patients with acute muscle spasms due to causes other than those mentioned in inclusion criteria Patients with severe cardiac, renal or pulmonary disease, uncontrolled Diabetes Mellitus. Patients with peptic ulcer and GERD. Patients with known hypersensitivity reaction to any of the drugs in study. Patients with spinal deformities like scoliosis, Kyphosis, Lordosis, Fixed pelvic obliquity. Patients with hyperlaxity of joints. Any primary hip disorder or sacroiliac joint pathology. Hamstring spasm. Patients unwilling or unable to comply with the study procedures.

Design outcomes

Primary

Measure	Time frame
1.Visual analogue scale 2.Tenderness of paravertebral muscles 3.Finger to floor distance (FFD) in cm 4.Modified Schoberâ??s test (10/15 Lumbar) 5.Global assessment of efficacy of treatmentTimepoint: Days 3, 5, 7 and 2 weeks after last dose	—

Secondary

Measure	Time frame
1.Visual analogue scale 2.Tenderness of paravertebral muscles 3.Finger to floor distance (FFD) in cm 4.Modified Schoberâ??s test (10/15 Lumbar) 5.Global assessment of efficacy of treatmentTimepoint: Days 3, 5, 7 and 2 weeks after last dose	—

Countries

India

Contacts

Public ContactDr Parag Sharma

Peoples College of Medical Sciences and Research Centre

drparagsharma@yahoo.com09424440731

Outcome results

None listed

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