Comparing two types of epidural for sciatica pain

Supraneural versus Infraneural Approach to transforaMinal Epidural StEroid injection for unilateral lumbosacral radicular pain (SIAMESE): A randomised non-inferiority trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36195887

Enrollment

Registered

2022-08-05

Start date

2022-10-01

Completion date

Unknown

Last updated

2023-08-28

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

Conditions

Lumbosacral radicular pain (sciatica) Nervous System Diseases

Interventions

Participants will be in the trial for 12 months in total, with 7 trial visits. Once consent has been obtained the researcher will provide participants with questionnaires and a programmed Actiwatch. P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 or over 2. Sciatica secondary to prolapsed intervertebral disc 3. At least 3 months of symptoms 4. Leg pain of 5 or more on 0-10 NRS, not responsive to at least one form of conservative treatment 5. Diagnosis confirmed by magnetic resonance imaging (MRI) showing paracentral disc bulge filling the lateral recess

Exclusion criteria

Exclusion criteria: 1. Age under 18 years 2. Sciatica due to fixed lesions such as facet or ligamentous hypertrophy, far lateral disc bulge, spinal stenosis, or spondylolisthesis 3. History of epidural steroid injection in the last 12 months 4. History of spinal surgery at any lumbar levels 5. Serious neurological deficit 6. Anatomical abnormalities posing technical challenges or contraindication to one of the injection routes and precluding randomisation 7. Pregnancy* 8. Active metastatic disease 9. Cancer or infection as a cause of back pain 10. Inability to provide written informed consent 11. Adults with incapacity 12. Vulnerable adults, as defined by Adult Support and Protection (Scotland) act (2007)

Design outcomes

Primary

Measure	Time frame
Weighted-average pain intensity numerical rating scores at 3 months after epidural injection.	—

Secondary

Measure	Time frame
1. Pain intensity scores at 1 week and 1, 3, 6, 9 and 12 months using numerical rating scale. 2. Objective sleep parameters and activity at 1 and 3 months measured using an Activity watch. 3. Subjective sleep parameters at 1 week and 1, 3, 6, 9 and 12 months using the Pain and Sleep Questionnaire three item index sleep scale. 4. Physical functioning scores at 1 week and 1, 3, 6, 9 and 12 months using the Oswestry Disability Index. 5. Emotional functioning scores at 3 months using the Patient Health Questionnaire 6. Requirement for additional treatments during the study (12 months) 7. Adverse events related to the epidural at 2 weeks	—

Measure

Time frame

1. Pain intensity scores at 1 week and 1, 3, 6, 9 and 12 months using numerical rating scale. 2. Objective sleep parameters and activity at 1 and 3 months measured using an Activity watch. 3. Subjective sleep parameters at 1 week and 1, 3, 6, 9 and 12 months using the Pain and Sleep Questionnaire three item index sleep scale. 4. Physical functioning scores at 1 week and 1, 3, 6, 9 and 12 months using the Oswestry Disability Index. 5. Emotional functioning scores at 3 months using the Patient Health Questionnaire 6. Requirement for additional treatments during the study (12 months) 7. Adverse events related to the epidural at 2 weeks

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Countries

Scotland, United Kingdom

Outcome results

None listed

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