Thoicolchicoside Oral Spray in Acute Non Specific Low Back Pai

Phase 3

Completed

Conditions: Health Condition 1: null- Acute Non Specific Low Back Pain

Registration Number: CTRI/2012/11/003107

Lead Sponsor: incoln Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

1. Patient with either sex with the age between 16 and 70 years.

2. Non specific low back pain with an acute episode of recent onset ( <48 hours) defined by average pain within the last 24 hours on the Visual Analogue Scale (VAS).

3. Ability to understand and comply with protocol requirements.

4. Patients who have signed and dated their written informed consent prior to initial of the study.

5. Low back pain of diagnosis category 1 (low back pain radiating no further than the knee), as defined by the International Paris Task Force on Back Pain.

Exclusion Criteria

1. Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins

2. Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol

3. Positive history of cerebro-vascular accidents

4. Patients treated during two days prior to inclusion with steroidal agents.

5. Known or suspected hypersensitivity to thiocolchicoside.

6. Concomitant treatment with 2-agonists (i.e. clonidine).

7. Pregnant or breast feeding women.

8. Females of child bearing potential, not taking adequate contraception.

9. Patients with history of alcohol, drugs or narcotics abuse.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average pain within the last 24 hours (VAS -I) at Day 1 (before starting treatment), Day 3 & Day 8Timepoint: at Day 1 (before starting treatment), Day 3 & Day 8

Secondary Outcome Measures

Name	Time	Method
-Pain on movement (VAS - II) at D1, D3 and D8 <br/ ><br>-Stiffness (Hand-to-floor distance) at D1, D3 and D8 <br/ ><br>-Disability (Roland Morris questionnaire) at D1, D3 and D8 <br/ ><br>-Patient perceived change after treatment (Global Perceived Effect, GPE) at D8Timepoint: at Day 1 (before starting treatment), Day 3 & Day 8