Plain English Summary
Background and study aims
Chronic low back pain is the biggest factor limiting activity in young adults under the age of 45. Discogenic pathology (a disorder originating in or from an intervertebral disc in the spine) is estimated to be responsible for chronic low back pain in between 7% and 39% of patients in several studies. Degenerative changes (gradual loss of the normal structure and function of the spine over time) can result in pain. Discogenic low back pain problems require the presence of free nerve endings and inflammation; a high concentration of nerves and vessels is present in the outer third of the annulus and the endplate areas (parts of spine), likely the sites where pain is produced. Several treatment options have been developed for reducing pain. There is weak evidence for intradiscal electrothermic therapy (IDET), radiofrequency annuloplasty, thoracic duct drainage (TDD) and radiofrequency denervation of the ramus communicans nerve.
The aim of this study is to investigate the value of radiofrequency heat lesion applied through the skin to the ramus communicans nerve and to determine if a significant and long-lasting pain reduction can be obtained as compared to a sham (dummy)-operated group. In addition to the above, a cost analysis will be performed for each individual treatment as well as for the complete healthcare system. The results will be used for further studies concerning intervention in spine-related pain disorders.
Who can participate?
Patients aged 18 or more with a case history and physical investigation suggestive of discogenic pain.
What does the study involve?
Group 1 (treatment group): percutaneous radiofrequency heat lesion (80°C, 60 sec) at the ramus communicans nerve
Group 2 (sham-operated group): same procedure as in group 1 except radiofrequency heat lesion.
What are the possible benefits and risks of participating?
Minimally invasive treatments provide alternatives for discogenic pain with the appeal of cost-effectiveness and, possibly, fewer long-term side effects. No major complications are reported.
Where is the study run from?
Lievensberg hospital, Bergen op Zoom, The Netherlands and Franciscus hospital, Roosendaal, The Netherlands.
When is the study starting and how long is it expected to run for?
Start date March 1, 2012; end date March 1, 2015.
Who is funding the study?
Centre for Pain Medicine, Erasmus Univeristy MC, Rotterdam, The Netherlands.
Who is the main contact?
C.W.J. van Tilburg, MD, FIPP
Randomised sham-controlled double-blind multicenter clinical trial to evaluate the percutaneous radiofrequency treatment for discogenic pain at the communicating ramus
Investigate the value of percutaneous radiofrequency heat lesion applied to the ramus communicans, more specifically, trying to determine if a significant and long lasting pain reduction can be obtained when compared to a sham-operated group. In addition to above, a cost analysis will be performed for each individual treatment as well as for the complete healthcare system. The results will be used for further studies concerning intervention in spine related pain disorders.
Ethics approval has been granted by the Medical Ethics Committee (Medisch Ethische Toetsings Commissie) (METC) Erasmus MC, Rotterdam, The Netherlands on February 7, 2012 (multicenter approval on July 10, 2012), reference number MEC-2011-242.
Randomised sham-controlled double-blind multicenter clinical trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Spine related pain disorders
Patients with chronic low back pain in whom anamnesis, physical investigation and additional investigations point towards a discogenic problem first receive a diagnostic ramus communicans block.
Ramus communicans diagnostic injection:
The ramus communicans of the affected lumbar disc is infiltrated. The diagnostic injection is performed fluoroscopically and by means of a Sluijter-Mehta Kit (SMK) needle (Cotop® via Neurotherm®, Wilmington, Massachusetts, United States) with an overall length of 15 cm. Local anesthesia with 1 mL lidocaine 2% is given for skin infiltration. The ramus communicans is infiltrated with 0,25 mL lidocaine 2%. The results of the diagnostic injections are rated according to Ostelo et al. (Ostelo, 2008), in which a positive result is obtained with a reduction in NRS of 2 or more on 10. Patients with a reduction in NRS of less than 2 on 10 drop out of the study.
When patients are candidates for the RCT they are randomised in two study groups:
(Continuous) radiofrequency [(C)RF] heat lesion of the ramus communicans versus sham:
Group 1 (treatment group): skin infiltration with 1 mL lidocaine 2%, percutaneous RF heat lesion (80 degrees Celcius during 60 sec. per level) with the NT2000 laesion generator (Neurotherm®, Wilmington, Massachusetts, United States) at the ramus communicans of the affected lumbar disc after local anesthesia with 0,5 mL lidocaine 2%
Group 2: sham-operated group (same procedure as in treatment group except for RF heat lesion).
This is followed with graded activity and follow up for both groups.
A crossover is provided for the sham-operated group after three months is no significant pain relief is obtained. The results of the crossover group will be analyzed separately, as well as compared with those who received the actual treatment in the first case.
Primary outcome measures
Pain reduction (NRS) measured at baseline,1, 3, 6 and 12 months.
Secondary outcome measures
1. Pain: Chronic Pain Acceptance Questionnaire (CPAQ) , Four-Dimensional Symptom Questionnaire (4DSQ), Multidimensional Pain Inventory (MPI-DLV) measured at baseline, 3 and 12 months
2. Disability: Oswestry Disability Index (ODI) measured at baseline, 3 and 12 months
3. Generic health status: Rand-36 measured at baseline, 3 and 12 months
4. Kinesiophobia: Tampa Scale for Kinesiophobia (TSK) measured at baseline, 3 and 12 months
5. Coping: Pain Coping Inventory (PCI), Pain Cognition List (PCL-2003) measured at baseline, 3 and 12 months
6. Costs of intervention
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Age 18 years or older
2. Anamnesis and physical investigation suggestive of discogenic pain on lumbar level
3. Decrease in numeric rating scale (NRS) of 2 or more / 10 on diagnostic ramus communicans block
Target number of participants
Participant exclusion criteria
1. Presence of red flags: possible fracture (major trauma, minor trauma in elderly or osteoporotic), possible tumor or infection (age >50 or <20, history of cancer, constitutional symptoms (fever, chills, weight loss), recent bacterial infection, IV drug abuse,
immunosuppression, pain worsening at night or when supine), possible significant neurological deficit (severe or progressive sensory alteration or weakness, bladder or bowel dysfunction, evidence of neurological deficit (in legs or perineum in the case of low back pain)
2. Lumboradicular syndrome
3. Aspecific low back pain
4. Corpus vertebrae problem
5. Progressive neurological deficits
6. Major psychiatric disorder (according to psychiatrists opinion)
7. Anticoagulation cannot be stopped
8. Active infection
9. Pain in other parts of the body that is more severe
10. Allergies to any medication used in the study
12. Communication (language) difficulties (according to physicians opinion)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Multidisciplinary pain centre
Bergen op Zoom
Erasmus University Medical Centre (MC) (Netherlands)
c/o F.J.P.M. Huygen
Centre for Pain Medicine
Centre for Pain Medicine, Erasmus University MC, Rotterdam (Netherlands)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting