A clinical trial of Diosmin's effects in the treatment of low back pai

Phase 4

Completed

• Conditions: Radicular pain; Signs and Symptoms

• Registration Number: ISRCTN97157037
• Lead Sponsor: anjing Drum Tower Hospital

Brief Summary

2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5651095/

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-12-01
• Study Start: 2017-06-13
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Preliminarily diagnosis of radicular pain
2. Aged 18 years and over
3. Pain duration at least 30 days
4. Underwent routine discography
5. Previously treated with nonsteroidal anti-inflammatory drugs, opioid medications or physical therapy without pain relief for more than one month
6. Normal or slight decrease in the height of disc space on lateral plain X-ray film
7. Initially considered eligible for surgical intervention

Exclusion Criteria

1. Spondylolysis
2. Lumbar canal stenosis
3. Isthmic or degenerative spondylolisthesis
4. Inflammatory arthritis
5. Spinal instability
6. Infection from previous lumbar surgery
7. Neurologic disease
8. Tumor
9. Psychological disorders (such as depression or using antidepressant/anxiolytic medications)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Perceived pain is measured using a visual analogue scale (VAS) and a numerical rating scale (NRS) just after the administration of drugs, and two and eight weeks later<br>2. Self-rated physical disability is measured using the Roland-Morris questionnaire (RM-Q) just after the administration of drugs, and two and eight weeks later

Secondary Outcome Measures

Name	Time	Method
Patient’s satisfaction is measured using a three-grade scale ranging from completely satisfied (no pain at all time and no restriction of activities) to satisfied (slight pain that requires no medication and mild restriction of activities) to unsatisfied (moderate to severe pain that requires medication and moderate to severe restriction of activities) via telephone after two years.