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A study comparing two minimally invasive injection-based treatments for lumbar disc herniation

A randomized controlled trial evaluating the efficacy and safety of standardized nanosurgery and bioengineered regenerative therapy compared with orthobiologic injections in patients with lumbar disc herniation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17213765
Enrollment
40
Registered
2026-06-18
Start date
2022-01-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Lumbar disc herniation Musculoskeletal Diseases

Interventions

The intervention group received a standardized nanosurgery and bioengineered therapy protocol consisting of one initial nanosurgical release followed by four stages of combined nanosurgical and regene

Sponsors

Wasilczyk Medical Clinic
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Clinical symptoms consistent with lumbar disc herniation 3. Low back pain with or without unilateral radicular pain 4. MRI-confirmed lumbar disc herniation corresponding to clinical symptoms 5. Ability to understand study procedures and comply with follow-up 6. Written informed consent provided by the participant

Exclusion criteria

Exclusion criteria: 1. Previous lumbar spine surgery at the index level 2. Urgent indication for surgical intervention, including cauda equina syndrome or progressive neurological deficit 3. Spinal infection, tumour, fracture, or inflammatory spinal disease 4. Significant spinal instability 5. Spondylolisthesis 6. Severe spinal stenosis considered the primary source of symptoms 7. Active infection 8. Coagulation disorders 9. Any contraindication to the planned procedures 10. Pregnancy 11. Inability to provide informed consent 12. Inability to comply with follow-up assessments

Design outcomes

Primary

MeasureTime frame
Functional disability measured using the Oswestry Disability Index at baseline and 12 months

Secondary

MeasureTime frame
Pain measured using the VAS scale at baseline and 12 months

Countries

Poland

Contacts

Public ContactCezary Wasilczk
wasilczyk.chirurg@gmail.com+48 (0)502200590

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026