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A study to determine the efficacy of radiofrequency ablation (a method of management for long-standing low back pain).

Transforaminal Epidural Injection of Local Anesthetic and Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Lumbosacral Radicular Pain- A Randomized, Triple-Blind, Active-Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/02/006666
Enrollment
80
Registered
2016-02-19
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- Adult patients with a history of segmental low back pain of more than 3 months duration, refractory to conventional physiotherpy and analgesics with predominant leg pain over back pain.

Interventions

Intervention1: Pulsed Radiofrequency ablation: After attaching the standard monitors and securing iv access, the patient is made prone. Under all aseptic precautions, 2% preservative-free lignoaine is

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • History of segmental low back pain of lumbar or sacral origin with radiation to legs below knee of more than 3 months duration, refractory to conventional physiotherpy and analgesics. • History of predominant leg pain over back pain. • Pain involving up to two lumbar levels. • Average pain score of >=5 on a 11-point NRS. • Computed tomography/Magnetic resonance imaging evidence of nerve root pain concordant with the side and level of clinical features. • Informed consent. • No significant compression of dural sac or nerve root.

Exclusion criteria

Exclusion criteria: • Patient refusal to participate. • Coagulopathy and/or patients on anticoagulants. • Infection at the site of injection. • Hypersensitivity to local anesthetic and/or radiographic contrast agent. • Evidence of significant sensory or motor deficit. • Presence of anatomical deformity of spine e.g. scoliosis, kyphosis etc. • Evidence of severe psychiatric illness. • Presence of cancer as a cause of back pain. • Inability to communicate in Hindi/English. • History of previous back surgery or implant insertion. • Presence of diabetes mellitus, multiple sclerosis, cardiac pacemaker, pregnancy.

Design outcomes

Primary

MeasureTime frame
â?¢ â?¥50% or â?¥4 point reduction in an 11-point numeric scale (NRS 11) â?¢ â?¥50% or â?¥6 points reduction in GPE (Global Perceived Effect)Timepoint: 2 weeks,1 month, 2 months, 3 months and 6 months.

Secondary

MeasureTime frame
â?¢ Mean NRS (Numerical Rating Scale) and improvement in functional status as measured by Modified Oswestry Disability Questionnaire (MODQ) at respective time intervals. â?¢ Employment status. â?¢ Analgesic intake.Timepoint: 2 weeks, 1 month, 2 months, 3 months and 6 months.

Countries

India

Contacts

Public ContactVirender Kumar Mohan

All India Institute of Medical Sciences

dr_vkmohan@yahoo.com9891557705

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 20, 2026