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we identified that the device tested in this study was not approved by Health canada
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The use of Botulinum toxin injections (BoNT-A) has become a standard therapy for children and youth who suffer from stiffness of their muscles due to a neurological problem. These injections are given into each muscles which require treatment, which often means receiving multiple injections in one session. Intramuscular injections are typically painful. Treatment can be provided unsedated and then should incorporate distraction and relaxation techniques, or can be alternatively be provided with the use of sedation.
To improve the pain experience the investigators want to assess the feasibility and impact on the pain perception when using a vibration device called the Buzzy during BoNT-A injections. The Buzzy creates a vibration that is applied over the injection site for 30 seconds before the injection and will be continued just above the injection site during the injection. The Buzzy has been shown to help reduce pain in procedures such as i.v. insertions and immunizations, but has not been tested in children and youth receiving multiple BoNT-A injections.
Children and youth who receive hypertonia treatment with non-sedated BoNT-A injection will be invited to participate in this clinical trial. The patients will be randomized to receiving the injection with the Buzzy versus the control group without the Buzzy. Both groups will still receive their typical supports that will include their choice of local anesthetic cream, relaxation and distraction techniques. Randomization will be stratified for the ability to self report.
Measures to capture the pain will include self report of pain, by using the Face Pain Scale revised (FPSr) in all participants who are able to self report. In addition all participants will be evaluated by the use of the Face, Legs, Activity, Cry and Consolability scale (FLACC scale), an observational tool validated to capture pain responses. The investigators will also include measurement of heart rate at rest, during and after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buzzy | Experimental | Participants will use the Buzzy, a small vibration device during their Botulinum toxin treatments. The Buzzy will be held over the injection site for 30 sec prior to the injection, then will be moved more rostral during the actual injection. The Buzzy will be applied in the same fashion to each targeted muscle. |
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| control - no Buzzy | No Intervention | Participants in the control group will receive their regular Botulinum toxin treatment without the use of the Buzzy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy | Device | The Buzzy will be applied for 30 seconds over the area that is going to be injected, then during the actual injection the Buzzy will be moved rostrally and continuously used during the injection. When the injection is completed the Buzzy is positioned in the same way over the next injection site. |
| Measure | Description | Time Frame |
|---|---|---|
| Faces Pain Scale revised | pain will be assessed by the use of the FPSr, a tool which was validated and been shown to be reliable in children and youth age 4 years and up. | The participants will be asked to rate their pain 3 minutes after the treatment. This will take about 2-5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| FLACC scale (base line) | The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10. | Baseline: Participants will be observed and rated on the FLACC scale 1 minute prior to the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronit Mesterman, M.D. | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Children's Hospital | Hamilton | Ontario | L8S 4 K1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19142573 | Background | Lukban MB, Rosales RL, Dressler D. Effectiveness of botulinum toxin A for upper and lower limb spasticity in children with cerebral palsy: a summary of evidence. J Neural Transm (Vienna). 2009 Mar;116(3):319-31. doi: 10.1007/s00702-008-0175-8. Epub 2009 Jan 14. | |
| 18387963 | Background | Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| FLACC scale (during intervention) | The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10. | Participants will be observed and rated on the FLACC scale during the intervention. Intervention time is typically 1-3 minutes. |
| FLACC scale (after intervention) | The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10. | Participants will be observed and rated on the FLACC scale 5 minutes after the intervention. |
| Heart rate (baseline) | Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain. | The heart rate will be captured 1 minute before the intervention |
| Heart rate (during intervention) | Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain. | The heart rate will be captured during the intervention. |
| Heart rate (after intervention) | Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain. | The heart rate will be captured 5 minutes after the intervention. |
| 23034364 | Background | Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013 Jan;109(1):5-12. doi: 10.1152/jn.00457.2012. Epub 2012 Oct 3. |
| 22728860 | Background | Fehlings D, Narayanan U, Andersen J, Beauchamp R, Gorter JW, Kawamura A, Kiefer G, Mason M, McCormick A, Mesterman R, Switzer L, Watt J. Botulinum toxin-A use in paediatric hypertonia: Canadian practice patterns. Can J Neurol Sci. 2012 Jul;39(4):508-15. doi: 10.1017/s0317167100014049. |
| 24924565 | Background | Whelan HM, Kunselman AR, Thomas NJ, Moore J, Tamburro RF. The impact of a locally applied vibrating device on outpatient venipuncture in children. Clin Pediatr (Phila). 2014 Oct;53(12):1189-95. doi: 10.1177/0009922814538494. Epub 2014 Jun 12. |
| 24912740 | Background | Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7. |
| 22001341 | Background | Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14. |
| 24134180 | Background | Russell K, Nicholson R, Naidu R. Reducing the pain of intramuscular benzathine penicillin injections in the rheumatic fever population of Counties Manukau District Health Board. J Paediatr Child Health. 2014 Feb;50(2):112-7. doi: 10.1111/jpc.12400. Epub 2013 Oct 18. |
| 12583869 | Background | Roy EA, Hollins M, Maixner W. Reduction of TMD pain by high-frequency vibration: a spatial and temporal analysis. Pain. 2003 Feb;101(3):267-274. doi: 10.1016/S0304-3959(02)00332-9. |
| 9220806 | Background | Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7. |
| 11427329 | Background | Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1. |
| 23922336 | Background | Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6. |