Percutaneous radiofrequency treatment for sacroiliac joint pain
| ISRCTN | ISRCTN45914408 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45914408 |
| Secondary identifying numbers | NL36871.078.11 |
- Submission date
- 07/07/2013
- Registration date
- 15/07/2013
- Last edited
- 25/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
In the past, research have appeared about the identification and treatment of sacroiliac (SI) joint pain (low back pain). The SI joint has been shown to be involved in 10% to 38% of the patients with chronic low back pain. For identifying SI joint problems, an injection into the joint is still being used. One of the most promising treatments is the use of radio frequency (RF) current (electricity). Several studies describe a good success rate with this kind of treatment. This study aims to find out the value of percutaneous radiofrequency heat lesion (application of heat produced by electric current through the skin) and to find out if a significant and long lasting pain reduction can be obtained as compared to when RF heat lesion was not given. In addition to the above, a cost of an individual treatment as well as cost to the complete healthcare system will be analyzed. The results will be used for further studies.
Who can participate?
Patients aged 18 or more with low back pain can participate in the study.
What does the study involve?
Patients will be randomly allocated to one of two groups. One group receives RF heat lesion treatment and the other group (control)receives treatment procedure that does not have RF heat lesion treatment. After three months, control group patients will receive RF heat lesion treatment. These results are compared separately.
What are the possible benefits and risks of participating?
This procedure is associated with a very small incidence of minor complications. No major complications were found in this procedure.
Where is the study run from?
This study is 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?
The study started in March 2012 and is expected to run until March 2015.
Who is funding the study?
Centre for Pain Medicine, Erasmus University MC, Rotterdam, The Netherlands.
Who is the main contact?
Dr C.W.J. van Tilburg
vtilburg@ziggo.nl
Contact information
Scientific
Multidisciplinary pain centre
Lievensberg hospital
Boerhaaveplein 1
Bergen op Zoom
4624 VT
Netherlands
Study information
| Study design | Randomised sham-controlled double-blind multicenter clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised sham-controlled double-blind multicenter clinical trial to evaluate the percutaneous radiofrequency treatment of sacroiliac joint pain |
| Study acronym | RF SIJ |
| Study objectives | Investigate the value of percutaneous radiofrequency heat lesion, applied to dorsal ramus of L5 and lateral branches of S1, S2, S3 and S4 nerve roots, more specifically, it tries to determine if a significant and long lasting pain reduction can be obtained as compared to a sham-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. |
| Ethics approval(s) | 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-2011-244. |
| Health condition(s) or problem(s) studied | Spine-related pain disorders |
| Intervention | Patients with chronic low back pain in whom anamnesis, physical investigation and additional investigations point towards a sacroiliac (SI) joint problem first receive a diagnostic SI joint block: Sacroiliac joint diagnostic injection: The diagnostic injection is performed fluoroscopically and by means of one Sluijter-Mehta Kit (SMK) needle (Cotop® via Neurotherm®, Wilmington, Massachusetts, United States) with an overall length of 10 cm. Local anesthesia with 1 mL lidocaine 2% is given for skin infiltration. Correct needle position is confirmed with contrast agent (iohexol (Omnipaque®) 240 mg/dL). The SI joint is infiltrated with 3 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 randomized in two study groups: Radiofrequency heat lesion of the posterior ramus of L5 and lateral branches of S1, S2, S3 and S4 with the Simplicity© III probe versus sham: Group 1 (treatment group): skin infiltration with 1 mL lidocaine 2% per level, infiltration of the course of the Simplicity© III needle with 10 mL lidocaine 2%, percutaneous radiofrequency heat lesion (85ºC, each step 1.5 minutes) with the NT2000 lesion generator (Neurotherm®, Wilmington, Massachusetts, United States) at the lateral branches of S1, S2, S3 and S4 nerve roots, percutaneous heat lesion (85ºC for 90 seconds, same laesion generator) of the L5 dorsal root primary ramus. Group 2 (sham-operated group): same procedure as in treatment group except for radiofrequency 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. |
| Intervention type | Other |
| Primary outcome measure | Pain reduction [Numerical Rating Scale (NRS)] measured on the day of first consultation, 1, 3, 6 and 12 months after treatment |
| Secondary outcome measures | 1. Pain: Chronic Pain Acceptance Questionnaire (CPAQ), Four-Dimensional Symptom Questionnaire (4DSQ), Multidimensional Pain Inventory (MPI-DLV) measured on the day of first consultation, 3 and 12 months after treatment 2. Disability: Oswestry Disability Index (ODI) measured on the day of first consultation, 3 and 12 months after treatment 3. Generic health status: Rand-36 measured on the day of first consultation, 3 and 12 months after treatment 4. Kinesiophobia: Tampa Scale for Kinesiophobia (TSK) measured on the day of first consultation, 3 and 12 months after treatment 5. Coping: Pain Coping Inventory (PCI), Pain Cognition List (PCL-2003) measured on the day of first consultation, 3 and 12 months after treatment 6. Costs of intervention |
| Overall study start date | 01/03/2012 |
| Completion date | 01/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Age 18 years or older 2. Anamnesis and physical investigation suggestive of SI joint pain 3. Decrease in NRS of 2 or more / 10 on diagnostic SI joint block |
| Key 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, intravenous (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 defecits 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 11. Pregnancy 12. Communication (language) difficulties (according to physicians opinion) |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 01/03/2015 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
4624 VT
Netherlands
Sponsor information
University/education
c/o F.J.P.M. Huygen
Centre for Pain Medicine
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | 25/06/2020 | Yes | No |
Editorial Notes
25/06/2020: Publication reference added.
