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The use of pulsed radiofrequency treatment into the atlantoaxial joint for the management of refractory head and neck pain.


- candidate number6534
- NTR NumberNTR2034
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2009
- Secondary IDs09.045 Orbis Medisch Centrum
- Public TitleThe use of pulsed radiofrequency treatment into the atlantoaxial joint for the management of refractory head and neck pain.
- Scientific TitleIntra-atlantoaxial (AA) joint pulsed radiofrequency treatment of the management of head and neck pain refractory to conservative treatment.
- ACRONYM
- hypothesisComplex symptoms such as suboccipital pain, irradiating into the occiput, vertex and sometimes as far as the eyes may originate from the atlantoaxial joint.
Intra-articular injections of corticosteroids were found to be more effective in patients suffering inflammatory disorders than in the subgroup with mechanical disorders.
Intra-articular application of pulsed radiofrequency was reported to be effective to treat intractable arthrogenic pain. Intra-atlantoaxial joint pulsed radiofrequency treatment may be a safer management for head and neck pain refractory to conventional treatment.
- Healt Condition(s) or Problem(s) studiedNeck pain, Facialgie, Suboccipital pain, Irradiating pain
- Inclusion criteria1. Age older than 18 year;
2. Head or neck pain refractory to conservative treatment;
3. Clinical examination indicative for atlantoaxial joint involvement;
4. Able to understand the information relative to the treatment;
5. Willing to provide written informed consent.
- Exclusion criteria1. Age younger than 18 years;
2. Pregnancy;
3. Malignancy, infectious diseases;
4. Coagulation disorders;
5. Previous surgery.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 3-jan-2008
- planned closingdate2-jan-2010
- Target number of participants100
- InterventionsPulsed radiofrequency 2Hz 10 msec, 8 min into the lateral atlantoaxial (AA) joint.
- Primary outcome1. Immediate effect and 2 months after procedure;
2. Pain reduction measured with 10-point verbal NRS;
3. Function improvement (clinical).
- Secondary outcome1. Duration of effect;
2. Follow-up one year after the procedure.
- TimepointsPre-procedure:
1. Pain intensity (10-point NRS);
2. Pain location (pain drawing);
3. Functionality (clinical examination, range of movement, stiffness, dizziness, tinnitus…).
Immediately post-procedure:
1. Pain intensity (10-point NRS).
2 months post procedure:
1. Pain intensity(10-point NRS);
2. Pain location (pain drawing);
3. Functionality (clinical examination, range of movement, stiffness, dizziness, tinnitus…).
12 months post procedure:
1. Pain intensity(10-point NRS).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES O. Rohof
- CONTACT for SCIENTIFIC QUERIES O. Rohof
- Sponsor/Initiator Orbis Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
Orbis Medisch Centrum
- PublicationsN/A
- Brief summaryThis trial is a pilot study to assess the feasibility of intra-atlantoaxial joint pulsed radiofrequency treatment, using a modified approach. The outcome of this treatment in a larger sample size should provide information allowing to decide on the possibility to perform a randomized controlled trial.
The condition treated, head and neck pain refractory to conservative management is frequenty seen in a pain clinic and interferes seriously with the patient's functionality and quality of life.
This trial is performed in one centre only, Orbis Medical Centre, Sittard-Geleen, in the pain clinic.
- Main changes (audit trail)
- RECORD29-sep-2009 - 29-okt-2009


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