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Pilot study on the effect of Intradiscal Pulsed RadioFrequency treatment for the management of low back pain and ischialgia of discogenic origin

Pilot study in patients with Degenerative Disc Disease and concordant pain with discography and the effect of percutaneous intradiscal Pulsed RadioFrequency treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN46778702
Enrollment
50
Registered
2011-02-23
Start date
2008-03-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Discogenic low back pain Musculoskeletal Diseases Dorsalgia

Interventions

Prior to inclusion in the study patients undergo extensive clinical examination. Attention for pain on flexion and deflexion and the odd biphasic deflexion. Tenderness when pressure is applied on the
0 = no pain and 10 = the worst imaginable pain) is noted and the analgesic use. The causative level is treated with pulsed radiofrequency. The electrode is placed in the nucleus. Pulsed radiofrequency

Sponsors

Orbis Medical Centre Sittard-Geleen (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients greater than 18 years old, either sex 2. Low back pain of greater than or equal to 6 months duration 3. Pharmacological treatment was used at appropriate doses for an accurate period of time without satisfactory pain relief and/or intolerable side effects 4. Physical therapy was used for a sufficiently long period of time (at least 6 weeks) to judge a potential effect 5. History and clinical examination is indicative for discogenic pain 6. Magnetic resonance imaging (MRI) confirms disc degeneration 7. Positive provocative discography

Exclusion criteria

Exclusion criteria: 1. Patients less than 18 years 2. Infection at the needle insertion site 3. Major coagulation disorders 4. Red flags: tumour, infection, fracture, spondylolisthesis grade 3, etc.

Design outcomes

Primary

MeasureTime frame
Pain reduction measured on a 10-point VAS score (0 = no pain, 10 = unbearable pain) at 3 months and at 12 months

Secondary

MeasureTime frame
1. Side effects and complications 2. Potential effect of additional treatment after the 3 month evaluation 3. Result measurement of combined treatment at 12 months follow up

Countries

Netherlands

Outcome results

None listed

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