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Pulsed radiofrequency for the treatment of low back pain.

Phase 4
Conditions
Health Condition 1: null- Low back pain with radicular pain.Health Condition 2: G541- Lumbosacral plexus disorders
Registration Number
CTRI/2018/01/011066
Lead Sponsor
Post Graduate Institute of Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Male and female patients over the age of 18 years who have a unilateral lumbar radicular pain due to disc herniation on magnetic resonance imaging, correlating clinically in terms of level and side and are due for elective PRF to treat their pain.

Exclusion Criteria

1. Other pain conditions that may confound the assessment of their radicular pain, as judged by the investigator(s)

2. Patients who have had previous back surgery to treat their radicular pain (‘failed back surgery syndrome’)

3. Patients with a known condition that may preclude their participation in the study, as judged by the investigator(s)

4. Patients taking anticoagulant or antiplatelet medication (except for low-dose aspirin), or known to have coagulation disorders, as judged by the investigator(s)

5. Patients with localized or systemic sepsis

a. Localized sepsis: infection of the skin at site of entry of the PRF probe

6. Breast-feeding women

7. Positive pregnancy test

8. Participation in other clinical trials, use of investigational drugs or procedures or use of experimental medications within 30 days prior to the enrolment visit

9. Previous randomisation in the present study

10. Females must not be breastfeeding.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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