Christine H Meyer-Frießem1,2, Lynn B Eitner1,3, Miriam Kaisler1, Christoph Maier1,3, Jan Vollert1,4,5, Andrea Westermann1, Peter K Zahn2, Carla A Avila González1,2,6. 1. Department of Pain Medicine, Ruhr-University Bochum, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH Bochum , Bochum , Germany. 2. Department of Anaesthesiology, Intensive Care, Palliative Care and Pain Medicine, Medical Faculty of Ruhr-University Bochum, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH Bochum , Bochum , Germany. 3. Department of Neuropediatrics, Ruhr-University Bochum, University Children's Hospital , Bochum , Germany. 4. Pain Research, Department of Surgery and Cancer, Imperial College , London , UK. 5. Neurophysiology, Center of Biomedicine and Medical Technology Mannheim CBTM, Medical Faculty Mannheim, Heidelberg University , Heidelberg , Germany. 6. Department of Anesthesiology, Intensive Care and Pain Medicine, Hessing Foundation , Augsburg , Germany.
Abstract
Objectives: Subcutaneous injection of botulinum toxin-A (sBONT-A) is a novel treatment for peripheral neuropathic pain. While its analgesic effects are well documented, this treatment is often not comfortable and fails in patients who show signs of sensory loss but rarely allodynia. There are some case reports about perineural BONT-A injection (pBONT-A) which could be an alternative approach. Here we present a retrospective, open label case series of pBONT-A's efficacy and safety regarding neurological consequences involving changes in somatosensory profiles of both responders and non-responders. Methods: Sixty patients (53 ± 13years, 77% males) with PNI were treated with pBONT-A after a test injection with a local anesthetic, which prompted distinctive pain relief. Quantitative sensory testing (QST; DFNS protocol) and pain intensity were assessed before and ≥7 days post pBONT-A injection. Definition of response: satisfactory pain reduction of ≥30% NRS (numerical rating scale: 0 = no pain, 10 = worst pain) for ≥4 days. Statistics: Paired t-test, Mann-Whitney U-test, χ2 test. Results: A temporary weak paresis in one case was clinically verified. The QST -parameters remained unchanged, but patients with more frequent hyperalgesia signs reported less analgesia (p = .04). The pBONT-A injection prompted pain relief by 24.8% (NRS: 6.0 ± 1.7 vs. 4.5 ± 2.1; p < .0001); 57% (n = 34) were responders (NRS: 6.0 ± 1.6 vs. 3.4 ± 1.6, relief of 43.4%; p < .0001). Based on these results, we suggest that future parallel design trials on pBONT-A need to include at least 84 patients. Discussion: Ultrasound-guided pBONT-A injection seems to be a safe treatment leading to a sufficient pain relief for some months without sensory changes. Surprisingly, pBONT-A showed a pronounced analgesic effect also in patients without signs of hyperalgesia.
Objectives: Subcutaneous injection of botulinum toxin-A (sBONT-A) is a novel treatment for peripheral neuropathic pain. While its analgesic effects are well documented, this treatment is often not comfortable and fails in patients who show signs of sensory loss but rarely allodynia. There are some case reports about perineural BONT-A injection (pBONT-A) which could be an alternative approach. Here we present a retrospective, open label case series of pBONT-A's efficacy and safety regarding neurological consequences involving changes in somatosensory profiles of both responders and non-responders. Methods: Sixty patients (53 ± 13years, 77% males) with PNI were treated with pBONT-A after a test injection with a local anesthetic, which prompted distinctive pain relief. Quantitative sensory testing (QST; DFNS protocol) and pain intensity were assessed before and ≥7 days post pBONT-A injection. Definition of response: satisfactory pain reduction of ≥30% NRS (numerical rating scale: 0 = no pain, 10 = worst pain) for ≥4 days. Statistics: Paired t-test, Mann-Whitney U-test, χ2 test. Results: A temporary weak paresis in one case was clinically verified. The QST -parameters remained unchanged, but patients with more frequent hyperalgesia signs reported less analgesia (p = .04). The pBONT-A injection prompted pain relief by 24.8% (NRS: 6.0 ± 1.7 vs. 4.5 ± 2.1; p < .0001); 57% (n = 34) were responders (NRS: 6.0 ± 1.6 vs. 3.4 ± 1.6, relief of 43.4%; p < .0001). Based on these results, we suggest that future parallel design trials on pBONT-A need to include at least 84 patients. Discussion: Ultrasound-guided pBONT-A injection seems to be a safe treatment leading to a sufficient pain relief for some months without sensory changes. Surprisingly, pBONT-A showed a pronounced analgesic effect also in patients without signs of hyperalgesia.