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The goal of this clinical trial is to compare low-dose radiation therapy (LDRT) with intra-articular steroid injections in participants suffering from chronic lower back pain as cause of facet joint arthritis (FJA).
The main question[s] it aims to answer are:
However, there has been no published study providing scientific evidence by prospective randomized data on the effect of LDRT in patient suffering from facet osteoarthritis. LDRT seems a viable treatment method with anti-inflammatory potential and possible long-lasting benefit in pain resolution for patients with facet joint arthritis (FJA), which can prevent from an ultimate surgical treatment.
The rationale of this trial is to generate scientific evidence that LDRT is an alternative non-invasive treatment option for FJA, whose primary outcome "pain reduction" is equivalent to the most common treatment intra-articular steroid injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-articular steroid injections | Active Comparator | The intra-articular steroid injections are the most common standard of care to treat the lower back pain resulting from FJA. |
|
| Low-dose radiation therapy | Experimental | LDRT is commonly used as treatment for benign degenerative inflammatory disorders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular steroid injections | Drug | The patient will be placed in prone position and the facet joints will be imaged by pa-radiation path with attention to radiation protection. 20 mg Kenacort + 1 ml Bupivacain (2.5 mg/ml) will be injected into the affected facet joints. The patient is monitored after the intervention for another 30 minutes before leaving the hospital. In order to track the pain level, the patient will be instructed to keep a pain diary. The patient will be contacted via telephone 72h after the intervention and asked about the pain level. The intervention is finished after one consultation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain level, measured on a numeric rating scale (NRS) | Difference in pain score on a numeric rating scale (NRS) with values from 0 to 10 (0 = no pain, 10 = highest imaginable pain) | Baseline and 3 month after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reported (serious) adverse events ((S)AE) | Toxicity of LDRT measured by number and description of reported (S)AE (serious adverse events) | Up to 12 months |
| Percentage of patients with NRS<4 (equals responders) after first treatment session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Gomez Ordonez, Dr. med. | Kantonsspital Aarau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
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| ID | Term |
|---|---|
| D055013 | Osteoarthritis, Spine |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Prospective non-inferiority double-arm randomized controlled single centre trial
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| Low-dose radiation therapy | Radiation | The treatment consists of an informing consultation, a planning CT scan and a series of 10 radiation sessions delivered over 3.5 weeks ( = 12 visits in total). The clinical target volume (CTV) will be defined based on the MRI and SPECT/CT. Planning target volume (PTV) will be expanded in all directions by 0.5 cm beyond the CTV. Patients will be treated in a supine position with minimum 6 MV photons and a 3D-technique or volumetric modulated arc therapy (VMAT)-technique. A kilovolt (kV) and in exception a cone-beam CT will be performed before each treatment for positioning accuracy. A dose of 0.5 Gy x 10 fractions (3 times per week) will be delivered over 3.5 weeks. Each radiotherapy treatment session takes approximately 15 minutes. If a second radiotherapy series will be done (NRS 4-10 at visit 4), the radiotherapy dose und fractionation will be the same as the first series. |
|
Efficacy of LDRT measured by percentage of patients with NRS<4 (equals responders) after first treatment session.
| Up to 3.5 weeks |
| Percentage of patients with NRS<4 (equals responders) after six months | Efficacy of LDRT measured by percentage of patients with NRS<4 | At six months |
| Change in pain level, measured on a numeric rating scale (NRS) | Difference in pain score on a numeric rating scale (NRS) with values from 0 to 10 (0 = no pain, 10 = highest imaginable pain) | Baseline, at 6 and 12 months after randomization |
| Change in quality of life measured by the Short Form Health (SF)-36 questionnaire | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health or emotional wellbeing | Baseline, at 3, 6 and 12 months after randomization |
| D009140 |
| Musculoskeletal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |