Chronic Low Back Pain (CLBP)NCT07567404
Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogenic Pain
An observational study of Chronic Low Back Pain (CLBP), run by SRH Gesundheitszentrum Bad Herrenalb at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Intradiscal electrothermal Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2022to 1 May 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogenic Pain: a Ten-Year Retrospective Observational Clinical Study
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.
Read the detailed description
This retrospective observational cohort study was conducted at a single urban spine department. After obtaining IRB approval from the state medical board (Landesärztekammer Stuttgart, Germany, F-2020-177), all consecutive patients from the outpatient clinic between 2010 and 2013 who underwent intradiscal procedures-such as discography, intradiscal electrothermal therapy (IDET) for discogenic pain, or intradiscal nucleoplasty for radicular pain-were contacted and invited to participate in the study. Participants were asked to undergo a current MRI and complete the patient-reported outcome measures (PROMs) listed below. The study was conducted between 2022 and 2024.
Inclusion Criteria 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.
Enrollment Criteria 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.
Exclusion Criteria
Patients were excluded if they met any of the following conditions:
- 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.
Intradiscal Procedures Patients with specific low back pain in this study were treated with minimally invasive techniques prior to considering open surgeries, such as spinal fusion or sequestrectomy. All procedures were performed between 2010 and 2013 by a single spine surgeon experienced in intradiscal interventions. Patients with discogenic pain due to disc degeneration were treated with intradiscal electrothermal therapy (IDET) or nucleoplasty (ACUTHERM) for radicular pain using the NT2000iX generator (Abbott, USA) protocol as described previously (10).
Primary Outcomes The primary outcome of the study was to assess the degeneration of intervertebral discs using the Pfirrmann classification, comparing pre- and postoperative MRI images of punctured and non-punctured discs. Some preoperative MRI images were available from internal archives, while missing images were obtained directly from patients (on DVD) or requested from external radiology centers. Postoperative MRI images were performed in-house and were T2-weighted to ensure consistency and cost efficiency. The Pfirrmann classification, as described by Pfirrmann et al. (11), was used to evaluate intervertebral disc degeneration. This classification involves ordinally scaled stages based on disc structure, nucleus-annulus distinction, signal intensity, and disc height. To improve accuracy, each disc was classified four times in a blinded manner (twice by experienced radiologists and twice by the spinal surgeon). Intra- and interrater reliability was validated using Cohen's kappa and Fleiss' kappa tests, and the mean values of all four assessments were used for analysis.
Comparisons of Pfirrmann values included:
- The overall difference in disc degeneration (pre- vs. post-procedure).
- Intra-individual comparisons between punctured and adjacent non-punctured discs.
- Differences across surgical procedures (discography, IDET, ACUTHERM). To evaluate the impact of varying needle diameters (22-gauge for discography and 17-gauge for IDET/ACUTHERM), discs subjected to both discography and IDET were analyzed within the IDET group.
While the study lacked a true control group, adjacent intervertebral discs in the same patient were used as controls to reduce bias. Randomization was not possible due to limitations in surgical reports, recruitment, and allocation. Therefore, precise intra-individual comparisons were prioritized.
Secondary Outcomes Secondary outcomes included the percentage improvement in Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), and SF-36 Index scores, measured approximately 9.1 years after surgery compared to preoperative values. The NRS asked patients to rate their average pain intensity (back or leg pain) over the previous two weeks on a scale from 0 to 10. The ODI is a self-administered questionnaire measuring "back-specific disability" across 10 items with six response categories each. SF-36 assessed health-related quality of life in areas such as physical functioning, social functioning, and mental health.
To exclude severe changes in biometric data after 10 years we also assessed possible the biometric data at follow up.
Statistical Analysis Data were expressed as mean ± standard deviation (SD) or median with confidence interval (CI). Statistical significance was determined using the Wilcoxon signed-rank test or Mann-Whitney U test, depending on the data distribution and whether samples were paired or independent. Differences between groups were analyzed with the Mann-Whitney U test, with p-values < 0.05 considered significant. Spearman's correlation test assessed relationships between independent variables.
Intra- and interrater reliability for Pfirrmann classifications was evaluated using Cohen's kappa and Fleiss' kappa. The results were interpreted according to Landis and Koch (1977). All statistical analyses were performed using SPSS software (version XX; SPSS Inc., Chicago, IL, USA).
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Intradiscal electrothermal Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradiscal electrothermal TherapyProcedure or surgery
Intradiscal heating for denervation of nerve ingrowth via flouroscopy
| Study group | Role | What they receive |
|---|---|---|
| Intradiscal Procedure | Procedures 10 years ago performed included intradiscal nucleoplasty (ACUTHERM) and intradiscal electrothermal therapy (IDET). Receives: Procedure: Intradiscal electrothermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Pain scale (NRS 0=no pain to 10=worst pain) and general daily activity measurement (ODI, SF-36). The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability). The SF-36 Spine score measures eight distinct domains, often used to determine the Physical Component Summary (PCS) and Mental Component Summary (MCS):
Physical Functioning (PF) Role Limitations due to Physical Problems (RP) Bodily Pain (BP) General Health Perceptions (GH) Vitality/Energy (VT) Social Functioning (SF) Role Limitations due to Emotional Problems (RE) General Mental Health (MH). Each domain is scored from 0 to 100, with 100 representing the highest level of functioning or best health state.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start15 Jan 2022
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- SRH Gesundheitszentrum Bad Herrenalb
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Andreas Veihelmann, SRH Gesundheitszentrum Bad Herrenalb
- Investigators
- Andreas Veihelmann, Principal investigator, Sportklinik Klinikum Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567404
- Sponsor's protocol ID
- SRHGBadHerrenalb
- Status last verified
- May 2026
- First submitted
- 15 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data can be shared if necessary
Publications
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.
PubMed 39093100
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogenic Pain: a Ten-Year Retrospective Observational Clinical Study
- ClinicalTrials.gov ID
- NCT07567404
- Acronym / sponsor ID
- SRHGBadHerrenalb
- Conditions
- Chronic Low Back Pain (CLBP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SRH Gesundheitszentrum Bad HerrenalbResearch network
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This retrospective observational cohort study was conducted at a single urban spine department. After obtaining IRB approval from the state medical board (Landesärztekammer Stuttgart, Germany, F-2020-177), all consecutive patients from the outpatient clinic between 2010 and 2013 who underwent intradiscal procedures-such as discography, intradiscal electrothermal therapy (IDET) for discogenic pain, or intradiscal nucleoplasty for radicular pain-were contacted and invited to participate in the study. Participants were asked to undergo a current MRI and complete the patient-reported outcome measures (PROMs) listed below. The study was conducted between 2022 and 2024.
Inclusion Criteria 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.
Enrollment Criteria 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.
Exclusion Criteria
Patients were excluded if they met any of the following conditions:
- 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.
Intradiscal Procedures Patients with specific low back pain in this study were treated with minimally invasive techniques prior to considering open surgeries, such as spinal fusion or sequestrectomy. All procedures were performed between 2010 and 2013 by a single spine surgeon experienced in intradiscal interventions. Patients with discogenic pain due to disc degeneration were treated with intradiscal electrothermal therapy (IDET) or nucleoplasty (ACUTHERM) for radicular pain using the NT2000iX generator (Abbott, USA) protocol as described previously (10).
Primary Outcomes The primary outcome of the study was to assess the degeneration of intervertebral discs using the Pfirrmann classification, comparing pre- and postoperative MRI images of punctured and non-punctured discs. Some preoperative MRI images were available from internal archives, while missing images were obtained directly from patients (on DVD) or requested from external radiology centers. Postoperative MRI images were performed in-house and were T2-weighted to ensure consistency and cost efficiency. The Pfirrmann classification, as described by Pfirrmann et al. (11), was used to evaluate intervertebral disc degeneration. This classification involves ordinally scaled stages based on disc structure, nucleus-annulus distinction, signal intensity, and disc height. To improve accuracy, each disc was classified four times in a blinded manner (twice by experienced radiologists and twice by the spinal surgeon). Intra- and interrater reliability was validated using Cohen's kappa and Fleiss' kappa tests, and the mean values of all four assessments were used for analysis.
Comparisons of Pfirrmann values included:
- The overall difference in disc degeneration (pre- vs. post-procedure).
- Intra-individual comparisons between punctured and adjacent non-punctured discs.
- Differences across surgical procedures (discography, IDET, ACUTHERM). To evaluate the impact of varying needle diameters (22-gauge for discography and 17-gauge for IDET/ACUTHERM), discs subjected to both discography and IDET were analyzed within the IDET group.
While the study lacked a true control group, adjacent intervertebral discs in the same patient were used as controls to reduce bias. Randomization was not possible due to limitations in surgical reports, recruitment, and allocation. Therefore, precise intra-individual comparisons were prioritized.
Secondary Outcomes Secondary outcomes included the percentage improvement in Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), and SF-36 Index scores, measured approximately 9.1 years after surgery compared to preoperative values. The NRS asked patients to rate their average pain intensity (back or leg pain) over the previous two weeks on a scale from 0 to 10. The ODI is a self-administered questionnaire measuring "back-specific disability" across 10 items with six response categories each. SF-36 assessed health-related quality of life in areas such as physical functioning, social functioning, and mental health.
To exclude severe changes in biometric data after 10 years we also assessed possible the biometric data at follow up.
Statistical Analysis Data were expressed as mean ± standard deviation (SD) or median with confidence interval (CI). Statistical significance was determined using the Wilcoxon signed-rank test or Mann-Whitney U test, depending on the data distribution and whether samples were paired or independent. Differences between groups were analyzed with the Mann-Whitney U test, with p-values < 0.05 considered significant. Spearman's correlation test assessed relationships between independent variables.
Intra- and interrater reliability for Pfirrmann classifications was evaluated using Cohen's kappa and Fleiss' kappa. The results were interpreted according to Landis and Koch (1977). All statistical analyses were performed using SPSS software (version XX; SPSS Inc., Chicago, IL, USA).
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intradiscal Procedure | – | Procedure: Intradiscal electrothermal TherapyProcedures 10 years ago performed included intradiscal nucleoplasty (ACUTHERM) and intradiscal electrothermal therapy (IDET). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- • Perioperative complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradiscal electrothermal TherapyIntradiscal heating for denervation of nerve ingrowth via flouroscopy | Procedure or surgery | Intradiscal Procedure |
Primary outcome
degeneration of the punctured disc using Pfirrman's classificition
Time frame: 10 years
Ordinal scale of disc deneration with 5 degrees (1=no degeration until 5=complete degeneration of the disc)
1 secondary outcome
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.
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 39093100Veihelmann 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.
- Link of Ethik CommiteeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. All data can be shared if necessary
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Veihelmann principal investigator
Sportklinik Klinikum Stuttgart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain (CLBP), run by SRH Gesundheitszentrum Bad Herrenalb at 1 site in Germany.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degeneration of the punctured disc using Pfirrman's classificition (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07567404, which also lists 1 linked publication.
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 5 May 2026.