Study on low back pai

Phase 2

Completed

• Conditions: Health Condition 1: M259- Joint disorder, unspecifiedHealth Condition 2: null- Low back pain for 4 weeks or more18 to 50 years of age of both gender

• Registration Number: CTRI/2018/02/012112
• Lead Sponsor: Director General

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-03-24
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 31

Inclusion Criteria

1. Patients of either gender.

2. Patients in the age group of 18-50 years

3. Clinically diagnosed patients with low back pain persisting for 4 weeks or more as chief complaint. Characterized by intermittent, recurrent and episodic problem; and includes four type of pain: local, referred, radicular and that arising from secondary (protective) muscular spasm

Exclusion Criteria

1. Patients below 18 years and above 50 years of age.

2. Recent low back injury.

3. BMI < 20 and > 35

4. Pregnant or lactating women.

5. Spinal pathology viz; severe or progressive motor weakness or central disc prolapsed, lumbar spondylolisthesis, lumbar radiculopathy, pending litigation (e.g., workplace injury), carcinoma

6. Patients receiving concomitant drug therapy with NSAIDâ??s with wash out period of less than 7 days.

7. Any systemic illness viz; hypertension, diabetes mellitus, rheumatoid arthritis, HBV, HIV infection etc.

8. Bleeding disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in disease status will be assessed by grading/ scoring of McGill Pain Questionnaire and Oswestry Pain Disability index (ODI). <br/ ><br>Timepoint: 9 MONTHS

Secondary Outcome Measures

Name	Time	Method
To reduce disease burden thus improving quality of lifeTimepoint: 12 MONTHS