Muscle Spasticity Clinical Trial
Official title:
Randomized Controlled Trial of Virtual Reality for Pain Management in a Specialty Rehabilitation Context
Verified date | February 2023 |
Source | Gillette Children's Specialty Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Measure pain and anxiety during a putative painful medical procedure (i.e., botulinum toxin injections) when Virtual Reality is employed compared to standard of care only using a Randomized Controlled Trial study design.
Status | Active, not recruiting |
Enrollment | 49 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria: - Patients receiving botulinum toxin injections at Gillette Children's Specialty Healthcare Exclusion Criteria: - Patients who are fully anesthetized during their medical procedure - Non-English speaking parents/patients - Patients with history of motion sickness - Patients with epilepsy - Patients with a ventricular shunt - Patients who have surgery during the study time period |
Country | Name | City | State |
---|---|---|---|
United States | GilletteChildren's Specialty Healthcare | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Gillette Children's Specialty Healthcare |
United States,
Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12. — View Citation
Barney CC, Feyma T, Beisang A, Symons FJ. Pain experience and expression in Rett syndrome: Subjective and objective measurement approaches. J Dev Phys Disabil. 2015 Aug 1;27(4):417-429. doi: 10.1007/s10882-015-9427-3. Epub 2015 Mar 1. — View Citation
Barney CC, Krach LE, Rivard PF, Belew JL, Symons FJ. Motor function predicts parent-reported musculoskeletal pain in children with cerebral palsy. Pain Res Manag. 2013 Nov-Dec;18(6):323-7. doi: 10.1155/2013/813867. — View Citation
Bieri D, Reeve RA, Champion DG, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-150. doi: 10.1016/0304-3959(90)90018-9. — View Citation
Breau LM, Burkitt C. Assessing pain in children with intellectual disabilities. Pain Res Manag. 2009 Mar-Apr;14(2):116-20. doi: 10.1155/2009/642352. — View Citation
Breau LM, McGrath PJ, Camfield CS, Finley GA. Psychometric properties of the non-communicating children's pain checklist-revised. Pain. 2002 Sep;99(1-2):349-57. doi: 10.1016/s0304-3959(02)00179-3. — View Citation
Cacau Lde A, Oliveira GU, Maynard LG, Araujo Filho AA, Silva WM Jr, Cerqueria Neto ML, Antoniolli AR, Santana-Filho VJ. The use of the virtual reality as intervention tool in the postoperative of cardiac surgery. Rev Bras Cir Cardiovasc. 2013 Jun;28(2):281-9. doi: 10.5935/1678-9741.20130039. — View Citation
Fernandez-Blazquez MA, Avila-Villanueva M, Lopez-Pina JA, Zea-Sevilla MA, Frades-Payo B. Psychometric properties of a new short version of the State-Trait Anxiety Inventory (STAI) for the assessment of anxiety in the elderly. Neurologia. 2015 Jul-Aug;30(6):352-8. doi: 10.1016/j.nrl.2013.12.015. Epub 2014 Jan 28. English, Spanish. — View Citation
Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207. — View Citation
Hoffman HG, Doctor JN, Patterson DR, Carrougher GJ, Furness TA 3rd. Virtual reality as an adjunctive pain control during burn wound care in adolescent patients. Pain. 2000 Mar;85(1-2):305-9. doi: 10.1016/s0304-3959(99)00275-4. — View Citation
Hoffman HG, Patterson DR, Carrougher GJ. Use of virtual reality for adjunctive treatment of adult burn pain during physical therapy: a controlled study. Clin J Pain. 2000 Sep;16(3):244-50. doi: 10.1097/00002508-200009000-00010. — View Citation
Hoffman HG, Richards TL, Coda B, Bills AR, Blough D, Richards AL, Sharar SR. Modulation of thermal pain-related brain activity with virtual reality: evidence from fMRI. Neuroreport. 2004 Jun 7;15(8):1245-8. doi: 10.1097/01.wnr.0000127826.73576.91. — View Citation
Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006. — View Citation
Hoffman HG, Sharar SR, Coda B, Everett JJ, Ciol M, Richards T, Patterson DR. Manipulating presence influences the magnitude of virtual reality analgesia. Pain. 2004 Sep;111(1-2):162-8. doi: 10.1016/j.pain.2004.06.013. — View Citation
Hua Y, Qiu R, Yao WY, Zhang Q, Chen XL. The Effect of Virtual Reality Distraction on Pain Relief During Dressing Changes in Children with Chronic Wounds on Lower Limbs. Pain Manag Nurs. 2015 Oct;16(5):685-91. doi: 10.1016/j.pmn.2015.03.001. Epub 2015 May 9. — View Citation
Jones T, Moore T, Choo J. The Impact of Virtual Reality on Chronic Pain. PLoS One. 2016 Dec 20;11(12):e0167523. doi: 10.1371/journal.pone.0167523. eCollection 2016. — View Citation
Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13. — View Citation
Norton M, Holm JE, McSherry WC 2nd. Behavioral assessment of relaxation: the validity of a Behavioral Rating Scale. J Behav Ther Exp Psychiatry. 1997 Jun;28(2):129-37. doi: 10.1016/s0005-7916(97)00004-9. — View Citation
Perpina-Galvan J, Richart-Martinez M, Cabanero-Martinez MJ, Martinez-Dura I. Content validity of the short version of the subscale of the State-Trait Anxiety Inventory (STAI). Rev Lat Am Enfermagem. 2011 Jul-Aug;19(4):882-7. doi: 10.1590/s0104-11692011000400005. English, Portuguese, Spanish. — View Citation
Phan A, Edwards CL, Robinson EL. The assessment of pain and discomfort in individuals with mental retardation. Res Dev Disabil. 2005 Sep-Oct;26(5):433-9. doi: 10.1016/j.ridd.2004.10.001. — View Citation
Ramstad K, Jahnsen R, Skjeldal OH, Diseth TH. Characteristics of recurrent musculoskeletal pain in children with cerebral palsy aged 8 to 18 years. Dev Med Child Neurol. 2011 Nov;53(11):1013-8. doi: 10.1111/j.1469-8749.2011.04070.x. — View Citation
Santosh PJ, Baird G. Psychopharmacotherapy in children and adults with intellectual disability. Lancet. 1999 Jul 17;354(9174):233-42. doi: 10.1016/S0140-6736(98)07059-7. — View Citation
Schmitt YS, Hoffman HG, Blough DK, Patterson DR, Jensen MP, Soltani M, Carrougher GJ, Nakamura D, Sharar SR. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns. Burns. 2011 Feb;37(1):61-8. doi: 10.1016/j.burns.2010.07.007. Epub 2010 Aug 7. — View Citation
Sharar SR, Carrougher GJ, Nakamura D, Hoffman HG, Blough DK, Patterson DR. Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S43-9. doi: 10.1016/j.apmr.2007.09.004. — View Citation
Sharar SR, Miller W, Teeley A, Soltani M, Hoffman HG, Jensen MP, Patterson DR. Applications of virtual reality for pain management in burn-injured patients. Expert Rev Neurother. 2008 Nov;8(11):1667-74. doi: 10.1586/14737175.8.11.1667. — View Citation
Shinde SK, Danov S, Chen CC, Clary J, Harper V, Bodfish JW, Symons FJ. Convergent validity evidence for the Pain and Discomfort Scale (PADS) for pain assessment among adults with intellectual disability. Clin J Pain. 2014 Jun;30(6):536-43. doi: 10.1097/AJP.0000000000000020. — View Citation
Steele E, Grimmer K, Thomas B, Mulley B, Fulton I, Hoffman H. Virtual reality as a pediatric pain modulation technique: a case study. Cyberpsychol Behav. 2003 Dec;6(6):633-8. doi: 10.1089/109493103322725405. — View Citation
Vega-Avelaira D, McKelvey R, Hathway G, Fitzgerald M. The emergence of adolescent onset pain hypersensitivity following neonatal nerve injury. Mol Pain. 2012 Apr 24;8:30. doi: 10.1186/1744-8069-8-30. — View Citation
Victoria NC, Inoue K, Young LJ, Murphy AZ. A single neonatal injury induces life-long deficits in response to stress. Dev Neurosci. 2013;35(4):326-37. doi: 10.1159/000351121. Epub 2013 Jul 5. — View Citation
Wittwer A, Krummenacher P, La Marca R, Ehlert U, Folkers G. Salivary Alpha-Amylase Correlates with Subjective Heat Pain Perception. Pain Med. 2016 Jun;17(6):1131-6. doi: 10.1093/pm/pnv085. Epub 2016 Jan 13. — View Citation
* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections. | The Faces Pain Scale - Revised (FPS-R) will be used to assess pain intensity before, during, and after the treatment session. The FPS-R is a self-report measure of pain intensity developed for children. This scale shows a serious of six faces depicting increasing intensity of pain expression. The FPS-R instructions orient the child to the series of faces and then ask the child to point to the face that shows how much they hurt right now. Each face corresponds to a numerical rating between 0 and 10 (0, 2, 4, 6, 8, and 10). This rating scale corresponds to the widely accepted 0-to-10 metric for pain. The "0" equals no pain and the "10" equals very much pain. The score is reported as a total score. | 2 days | |
Secondary | A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR. | A visual analogue scale (VAS) will be used to quantify multiple aspects of the treatment experience expected to be impacted by the use of VR. The VAS will be a 10 cm 0-100 scale and will assess the following: patient anxiety before, during and after the procedure; parent/caregiver anxiety before, during, and after the procedure; proportion of the treatment time spent thinking about pain; worst pain during treatment; satisfaction with pain management; and nausea during treatment. This will be done at both visits (VR and no-VR). | 2 days | |
Secondary | Information collected from the medical record (e.g., medication use during procedure). | Following the signing of a HIPPA release, the medical record will be accessed to obtain such information as: patient diagnosis, date of birth, ethnicity, number of botulinum toxin injections, muscles injected, patient weight, height, and temperature, heart rate, blood pressure and oxygen saturation during treatment, clinical description of the context of VR use; provider description of whether VR enhanced clinical care; reduction or avoidance of medication due to VR; total amounts of medications given (e.g., valium, nitrous oxide, opioids; mg/kg); and notation of patient side effects from VR. This will be done at both visits (VR and no-VR). | 2 days | |
Secondary | The Pain Opinion Questionnaire (POQ) | The Pain Opinion Questionnaire (POQ) requires caregivers to respond to 5 questions in 3 separate sections regarding children with mild, moderate, and severe/profound intellectual and developmental disabilities. A description of the abilities and limitations of a typical individual with each level of impairment is provided in each section. The questions address 5 facets of pain: (a) the ability of the children to sense painful stimuli (Sensation), (b) how upset or distressed the children feel while in pain (Emotional Reaction), (c) how strongly the children react behaviorally to pain (Behavioral Reaction), (d) how much the children communicate their pain to others (Communication), and (e) how much pain the children suffer (Frequency). We are modifying the scale to require parents or caregivers to estimate whether they believe their child (not a hypothetical child) would experience that aspect of pain the "same as", "less than", or "more than" children without impairment. | 2 days | |
Secondary | The Dalhousie Pain Interview (DPI) | The Dalhousie Pain Interview (DPI) will provide a measure of pain experience in the previous week, including pain frequency (number of pain episodes), intensity (rated 0-10) and duration (number of seconds or minutes in pain). The measure consists of 10 items and was designed explicitly as an interview/survey script. | 2 days | |
Secondary | The Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) will provide a measure of pain interference in the previous week (i.e., the degree to which ongoing pain interferes with daily living). The BPI is a 10-item, 11-point scale (0 = does not interfere, 10 = completely interferes). The items include general activity, mood, mobility, normal work, relationships with other people, sleep, enjoyment of life, self-care, recreational activities, and social activities. Total score (sum of all 12 items combined; range 0-120) and average score (average item score; range 0-10) will be assessed. | 2 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT02907775 -
Multi-channel Stimulation for Post Stroke Spasticity (MUSTS)
|
N/A | |
Recruiting |
NCT04530955 -
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
|
N/A | |
Completed |
NCT03080454 -
The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke
|
Phase 1/Phase 2 | |
Completed |
NCT02546999 -
Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?
|
Phase 4 | |
Active, not recruiting |
NCT01041157 -
Botulinum Toxin Injection Efficiency
|
Phase 1 | |
Terminated |
NCT00531466 -
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT00535938 -
MDs on Botox Utility (MOBILITY)
|
N/A | |
Terminated |
NCT00532532 -
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05546190 -
A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)
|
||
Recruiting |
NCT06117020 -
Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals
|
Phase 1 | |
Completed |
NCT01603628 -
BOTOX® Treatment in Pediatric Lower Limb Spasticity
|
Phase 3 | |
Completed |
NCT05510726 -
Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity
|
||
Not yet recruiting |
NCT04378946 -
Error Augmentation Motor Learning Training Approach in Stroke Patients
|
N/A | |
Completed |
NCT01603615 -
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
|
Phase 3 | |
Completed |
NCT01251380 -
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
|
Phase 3 | |
Completed |
NCT00549783 -
BOTOX® Economic Spasticity Trial (BEST)
|
Phase 4 | |
Completed |
NCT00210431 -
Post Marketing Surveillance Study of Dysport
|
||
Completed |
NCT00076687 -
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
|
Phase 2 | |
Completed |
NCT04543448 -
Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis
|
N/A |