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

Completed

Conditions: Discogenic low back pain
Musculoskeletal Diseases
Dorsalgia

Registration Number: ISRCTN46778702

Lead Sponsor: Orbis Medical Centre Sittard-Geleen (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

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

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Side effects and complications<br>2. Potential effect of additional treatment after the 3 month evaluation<br>3. Result measurement of combined treatment at 12 months follow up