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Prospective randomized controlled trial of selective nerve root blockade in patients with acute or subacute sciatica

Prospective randomized controlled trial of selective nerve root blockade in patients with acute or subacute sciatica

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94584126
Enrollment
88
Registered
2007-02-27
Start date
2003-05-30
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lumbar intervertebral disc herniation Musculoskeletal Diseases herniation

Interventions

Patients were randomized to either 1.0 cc Celestone (40 mg/mL) plus 1.0 cc 0.5% bupivicaine (treatment), or 1.0 cc sterile saline plus 1.0 cc 0.5% bupivicaine (control).

Sponsors

WorkSafeBC Research Secretariat (Canada)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 19 years or older 2. Pain in a single lower extremity below the level of the knee of less than 18 week duration 3. Presence of at least one of the following on physical examination - positive straight leg test, motor deficit, or reflex abnormality 4. Presence of a herniated nucleus pulposus (HNP) demonstrated by CT or MRI at a level and side corresponding to symptoms and signs

Exclusion criteria

Exclusion criteria: 1. History of an adverse reaction to local anaesthetic or steroids 2. Any spinal injection within the last 6 months 3. Cauda equina syndrome, progressive neurological deficit, or lower extremity weakness of less than 3/5

Design outcomes

Primary

MeasureTime frame
1. LegPain40: LegPain40 is a 0 to 40 aggregate pain score based on severity of pain/discomfort in the leg (sciatica) over the past week when it was i) most severe, ii) least severe, iii) average, and iv) at present time, with 0 being no pain and 10 being pain as bad as it can be. 2. BackPain10: BackPain10 is a 0 to 10 scale of severity of back pain/discomfort over the past week when it was most severe. 3. Modified Roland-Morris Disability Questionnaire (RDQ): RDQ measures the degree to which a patient?s functional capacity is limited by back pain. The modified RDQ is a 23-item questionnaire developed specifically for patients with sciatica, and has good internal consistency, validity, and responsiveness in this population of patients.

Secondary

MeasureTime frame
Rate of progression to surgery

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026