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Lumbar Disc HerniationSELDISCNCT07895589

Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation

A study testing Selective Nerve Root Block in people with Lumbar Disc Herniation and Lumbar Radiculopathy, run by Karolinska Institutet at 2 sites in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The SELDISC trial will investigate whether a selective nerve root block can reduce the need for surgery in adults with a herniated disc in the lower back. A herniated disc can irritate a nerve and cause pain that travels down the leg. Read more about this study

Who is it for?
Ages 18 to 66 years
What is being tested?
Selective Nerve Root Block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
262 participants
Where
2 sitesSweden
Study dates
Jan 2027to 31 Dec 2036
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria:
  • Age ≥18 years and <67 years at the time of consent.
  • MRI-verified single-level lumbar disc herniation corresponding to clinical symptoms.
  • Radiculopathy with leg-dominant pain consistent with the affected nerve root.
  • Failure of conservative treatment (e.g., physiotherapy, analgesics, activity modification) for at least 6 weeks, with surgery considered appropriate.
  • Duration of symptoms less than 12 months.
  • Deemed a candidate for lumbar disc surgery by the treating surgeon.
  • Ability to provide written informed consent and comply with study procedures.

Who cannot join

  • Participants will be excluded if any of the following are present:
  • Previous lumbar spine surgery or other lumbar intervention.
  • Multi-level disc herniations with an unclear symptomatic level.
  • Progressive or severe neurological deficit requiring urgent surgery (e.g., cauda equina syndrome, significant motor deficit).
  • Serious spinal pathology other than disc herniation (e.g., infection, tumour, fracture, inflammatory disease, lumbar idiopathic scoliosis, degenerative deformity).
  • Relevant systemic comorbidities that increase procedural risk or confound outcomes, including:
Show all 17Show fewer
  • Uncontrolled cardiovascular, pulmonary or metabolic disease.
  • Immunosuppressive therapy or systemic inflammatory disorders.
  • Psychiatric illness or cognitive impairment interfering with study participation.
  • Neurological disorders such as Parkinson's disease, multiple sclerosis or polyneuropathy.
  • Contraindications to injection therapy, including:
  • Uncontrolled coagulopathy or ongoing anticoagulation that cannot be safely reversed.
  • Local skin infection or systemic infection.
  • Known allergy to study medications (local anaesthetic, corticosteroid or contrast agent).
  • Pregnancy or breastfeeding.
  • Inability to understand the Swedish language.
  • Lack of a Swedish personal identification number.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anastasios Charalampidis, MD, PhD contact

+46707267961

anastasios.charalampidis@ki.se

Elias Diarbakerli, PhD contact

+46704240061

elias.diarbakerli@ki.se

Sweden2 sites
  • Karolinska University Hospital

    Stockholm

    Anastasios Charalampidis, MD, PhD, +46707267961, anastasios.charalampidis@ki.se

    Anastasios Charalampidis, MD, PhD

  • Stockholm Center for Spine Surgery (RKC)

    Stockholm

    Martin Skeppholm, MD, PhD, +46703669897, martin.skeppholm@rkc.se

    Martin Skeppholm, MD, PhD

Other trials in Sweden

About this study

Official title: SELDISC - A Trial on SELective Nerve Root Block for Lumbar DISC Herniation

The SELDISC trial will investigate whether a selective nerve root block can reduce the need for surgery in adults with a herniated disc in the lower back. A herniated disc can irritate a nerve and cause pain that travels down the leg. A nerve root block delivers a local anaesthetic and a corticosteroid near the affected nerve to relieve pain and inflammation.

The study will include 262 adults aged 18-66 years who have persistent leg symptoms despite non-surgical treatment and have been assessed by a spine surgeon as eligible for surgery.

Read more

Participants will be randomly assigned to receive either a selective nerve root block or a sham procedure that mimics the treatment without delivering the active medication near the nerve. Each participant will have an equal chance of receiving either procedure. Participants and the study staff assessing their outcomes will not know which procedure was given. The radiologist performing the procedure will know the allocation.

The main question is whether fewer participants in the nerve root block group undergo surgery within 12 months after randomisation. The study will also compare pain, disability, quality of life, time to surgery, medication use, sick leave, healthcare use and adverse events between the groups.

Read the detailed description

Selective nerve root blocks are used to treat radicular pain associated with lumbar disc herniation. However, their ability to reduce subsequent surgery in patients already considered eligible for surgical treatment remains uncertain. SELDISC will evaluate whether the therapeutic effect of a selective nerve root block exceeds the contextual and procedural effects of a sham intervention.

The trial uses multicentre recruitment with study procedures performed at the Department of Neuroradiology, Karolinska University Hospital, Sweden. Eligible patients will be identified through clinical assessment, review of magnetic resonance imaging and confirmation of surgical candidacy. Following informed consent and baseline assessments, participants will undergo randomisation using a secure web-based system. Allocation concealment will be maintained through a computer-generated sequence with variable block sizes, stratified by recruitment centre and age. Participants will be offered an appointment for the allocated procedure within 72 hours of enrolment.

The sham procedure is designed to reproduce the experience of the active procedure, including preparation, superficial local anaesthesia and image-guided needle placement, without administering a therapeutic injection near the nerve root. The neuroradiologist performing the procedure will know the treatment allocation but will not participate in subsequent clinical care or outcome assessment. Participants, treating surgeons and outcome assessors will remain blinded.

Clinical information and patient-reported outcomes will be collected prospectively and recorded in an electronic study database. Data from medical records and the Swedish Spine Register (Swespine) will supplement study assessments. The economic evaluation will compare costs and quality-adjusted life years between the treatment groups.

Eligible patients who decline randomisation may be followed through Swespine as a separate observational cohort to assess the representativeness of the randomised population. This cohort will not form part of the randomised treatment comparison.

Being tested
Selective Nerve Root Block, Sham Procedure
Keywords
selective nerve root block, SNRB, Sciatica, Corticosteroid injection, Sham-controlled trial, Lumbar disc surgery, SELDISC
Medical subject headings
Intervertebral Disc Displacement, Radiculopathy, Sciatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selective Nerve Root BlockProcedure or surgery

    Fluoroscopy-guided needle placement at the affected lumbar nerve root, followed by contrast administration to confirm needle position and injection of a local anaesthetic and a depot corticosteroid.

  • Sham ProcedureProcedure or surgery

    Superficial local anaesthesia and fluoroscopy-guided needle placement to mimic a selective nerve root block, without contrast or therapeutic injectate administration near the nerve root.

Study groups in NCT07895589
Study groupRoleWhat they receive
Selective nerve root blockExperimentalParticipants will receive a fluoroscopy-guided selective nerve root block at the affected lumbar nerve root, with injection of a local anaesthetic and a corticosteroid.
Receives: Procedure: Selective Nerve Root Block
Sham procedureSham comparatorParticipants will undergo a sham procedure that reproduces the preparation, superficial local anaesthesia and image-guided needle placement of the active intervention, without administering any injectate near the nerve root.
Receives: Procedure: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants undergoing lumbar disc surgery

    Proportion of participants who undergo surgery for the index lumbar disc herniation within 12 months after randomisation. The outcome is recorded for each participant as yes or no.

    Measured: Within 12 months after randomisation

Secondary outcomes (24)
  1. Time to lumbar disc surgery

    Number of days from randomisation to the first surgery for the index lumbar disc herniation. Participants without surgery will be censored at their last follow-up or at 365 days, whichever occurs first.

    Measured: From randomisation to 12 months

  2. Leg pain intensity measured using the Visual Analogue Scale

    Leg pain intensity measured using a Visual Analogue Scale (VAS) ranging from 0 to 100 mm, with higher scores indicating greater pain. The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses.

    Measured: Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation

  3. Back pain intensity measured using the Visual Analogue Scale

    Back pain intensity measured using a Visual Analogue Scale (VAS) ranging from 0 to 100 mm, with higher scores indicating greater pain. The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses.

    Measured: Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation

  4. Leg pain intensity measured using the Numeric Rating Scale

    Leg pain intensity measured using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses.

    Measured: Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation

  5. Back pain intensity measured using the Numeric Rating Scale

    Back pain intensity measured using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses.

    Measured: Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation

  6. Oswestry Disability Index

    Disability measured using the Oswestry Disability Index (ODI), version 2.0. Scores range from 0 to 100, with higher scores indicating greater disability. The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses.

    Measured: Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation

  7. Health-related quality of life measured using the EQ-5D-3L index

    Health-related quality of life measured using the EQ-5D-3L descriptive system and converted to an index using the selected value set. Higher index values indicate better health; 1 represents full health, and negative values represent health states valued below death. The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses.

    Measured: Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation

  8. Self-rated health measured using the EQ-VAS

    EQ-VAS, ranging from 0 (worst imaginable health) to 100 (best imaginable health). The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses.

    Measured: Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation

  9. Duration of sick leave

    Duration of sick leave during the follow-up period, recorded in days.

    Measured: From randomisation to 12 months

  10. Extent of sick leave

    Extent of sick leave during the follow-up period. Data will be collected from medical records, the Swedish Spine Registry (Swespine) and the Swedish Social Insurance Agency (Försäkringskassan).

    Measured: From randomisation to 12 months

  11. Healthcare visits related to lumbar disc herniation

    Number of healthcare visits related to lumbar disc herniation or its treatment during the follow-up period.

    Measured: From randomisation to 12 months

  12. Hospitalisations related to lumbar disc herniation

    Number of hospitalisations related to lumbar disc herniation or its treatment during the follow-up period.

    Measured: From randomisation to 12 months

  13. Re-interventions

    Number and type of additional interventions for lumbar disc herniation during the follow-up period, including additional nerve root injections outside the study protocol.

    Measured: From randomisation to 12 months

  14. Hospital readmissions

    Number of hospital readmissions related to lumbar disc herniation or its treatment during the follow-up period.

    Measured: From randomisation to 12 months

  15. Revision lumbar disc surgery

    Number of revision operations following the index lumbar disc surgery during the follow-up period.

    Measured: From randomisation to 12 months

  16. Adverse events

    Number and type of adverse events, including bleeding, infection, neurological deterioration, allergic reactions, steroid-related complications and vasovagal reactions. Severity will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events

    Measured: From randomisation to 12 months

  17. Serious adverse event

    Number and type of serious adverse events, defined according to Good Clinical Practice criteria, including death, life-threatening events and events requiring or prolonging hospitalisation.

    Measured: From randomisation to 12 months

  18. Surgical complications

    Number and severity of surgical complications among participants undergoing surgery, classified using the Clavien-Dindo classification and categorised as minor or major according to the protocol.

    Measured: From randomisation to 12 months

  19. Analgesic use

    Administered and prescribed doses of analgesics during follow-up. Opioid doses will be converted to oral morphine equivalents where applicable.

    Measured: From randomisation to 12 months

  20. Direct medical costs

    Direct medical costs associated with treatment and follow-up, including procedures, medications, imaging, outpatient visits, hospitalisations and additional interventions.

    Measured: From randomisation to 12 months

  21. Indirect costs

    Costs of productivity loss associated with sick leave during the follow-up period.

    Measured: From randomisation to 12 months

  22. Quality-adjusted life years

    Quality-adjusted life years calculated from EQ-5D-3L index values over the follow-up period. Higher values indicate greater health benefit.

    Measured: From randomisation to 12 months

  23. Incremental cost per surgery avoided

    Difference in costs between the selective nerve root block and sham groups divided by the difference in the proportion of participants avoiding lumbar disc surgery.

    Measured: From randomisation to 12 months

  24. Incremental cost per quality-adjusted life year gained

    Difference in costs between the selective nerve root block and sham groups divided by the difference in quality-adjusted life years.

    Measured: From randomisation to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionJan 2030 (estimated)
  4. Study completion31 Dec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomised in a 1:1 ratio to selective nerve root block or a sham procedure in two parallel groups. Randomisation will use a computer-generated sequence with variable block sizes, stratified by recruitment centre and age.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
262 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895589
Sponsor's protocol ID
2026-05512-01
Other IDs
FoUI-1042366, FoUI-1042522
Acronym
SELDISC
Status last verified
Oct 2026
First submitted
17 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD underlying published manuscripts will be accessible for other researchers. The investigators in charge will be responsible for reviewing access requests. Crude data, randomization procedures and intervention details can be shared with other researchers upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Selective Nerve Root Block in people with Lumbar Disc Herniation and Lumbar Radiculopathy, run by Karolinska Institutet at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anastasios Charalampidis, MD, PhD (+46707267961, anastasios.charalampidis@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants undergoing lumbar disc surgery (time frame: Within 12 months after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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