Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogenic Pain

NCT07567404 | Completed

• 1 other identifier: SRHGBadHerrenalb
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Procedures 10 years ago performed included intradiscal nucleoplasty (ACUTHERM) and intradiscal electrothermal therapy (IDET). At follow up MRI scans evaluated by two blinded specialists for disc degeneration were carried out. Intra- and interrater variability were accounted for. Baseline and 10-year post-procedure clinical parameters were compared.

Conditions

Chronic Low Back Pain (CLBP)

Outcome Measures

Primary Outcomes (1)

• degeneration of the punctured disc using Pfirrman's classificition

  Ordinal scale of disc deneration with 5 degrees (1=no degeration until 5=complete degeneration of the disc)

  10 years

Secondary Outcomes (1)

• As secundary outcome pain by numeric rating scale (NRS), oswestry disability index (ODI) and SF-36 which were recorded at baseline and 10 years after intervention.

  10 years

Study Arms (1)

Intradiscal Procedure

Procedures 10 years ago performed included intradiscal nucleoplasty (ACUTHERM) and intradiscal electrothermal therapy (IDET).

Procedure: Intradiscal electrothermal Therapy

Interventions

Intradiscal electrothermal Therapy PROCEDURE

Intradiscal heating for denervation of nerve ingrowth via flouroscopy

Intradiscal Procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

To be included in the retrospective study, patients must have undergone one of the specified intradiscal procedures, successfully established contact, voluntarily agreed to participate, and demonstrated sufficient language proficiency to complete study assessments.

You may qualify if:

• Patients eligible for early intradiscal procedures included those with low back pain (NRS \> 5) caused by discogenic pain due to disc degeneration or radicular pain due to disc protrusion and subsequent nerve root compression. All patients were required to have been resistant to conservative therapy. Diagnoses were based on patient history, physical examination, imaging studies, and, in some cases, provocative discography if discogenic pain could not otherwise be clearly identified.

You may not qualify if:

• Perioperative complications.
• Post-interventional lumbar spine surgery in the region to be examined.
• Contraindications for a repeated MRI.
• Metastases or infection of the spine since surgery.
• Spinal canal stenosis.
• A diagnosis of anxiety disorder, depression, or somatoform disorder since surgery, based on their medical history.

Sponsors & Collaborators

• SRH Gesundheitszentrum Bad Herrenalb: lead

Study Sites (1)

Sportklinik, Klinikum Stuttgart

Stuttgart, 70374, Germany

Location

Related Publications (1)

• Veihelmann A, Beck F, Huth J, Spetzger U, Schulze-Pellengahr C, Teske W. Minimal-invasive pain procedures are effective in different degenerative pain generators in CLBP: A prospective cohort study. Technol Health Care. 2024;32(6):4727-4741. doi: 10.3233/THC-241003.

  PMID: 39093100 BACKGROUND

Related Links

• Link of Ethik Commitee

Study Officials

• Andreas Veihelmann

  Sportklinik Klinikum Stuttgart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 5, 2026
• Study Start: January 15, 2022
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

DE (1)