Effektivitet og mekanismer for Virtual Reality-behandling af fantombensmerter
17. august 2026 opdateret af: Laurel Buxbaum, Albert Einstein Healthcare Network
Effektivitet og mekanismer ved Virtual Reality-behandling af fantombensmerter: personlig behandling
Efter amputation af en arm eller et ben oplever op til 90% af forsøgspersonerne et "fantomlem", et fænomen karakteriseret ved vedvarende følelser af det manglende lem.
Mange forsøgspersoner med et fantomlem oplever intens smerte i den manglende ekstremitet, som ofte reagerer dårligt på medicin eller andre indgreb.
Det foreslåede arbejde vil kontrastere effektiviteten af to virtual reality-behandlinger for fantomsmerter i lemmer: en 'Distractor' og en Active VR-behandling.
I Distractor-behandlingen er deltagerne engageret i en visuelt fordybende virtual reality-oplevelse, der ikke kræver benbevægelser (REAL i-Series® immersive VR-oplevelse).
I Active VR-behandlingen spiller forsøgspersoner en række VR-spil ved at bruge den virtuelle gengivelse af begge ben.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Næsten 2 millioner mennesker i USA har haft en amputation, og op til 90 % af personer med amputation af lemmer oplever den vedvarende fornemmelse af den manglende ekstremitet, et fænomen kendt som et "fantomlem" (Weeks et al., 2010). Derudover oplever en betydelig del af individer med et fantomlem - op til 85 % i nogle undersøgelser - vedvarende og invaliderende smerter i det manglende lem, en tilstand kendt som fantomlemsmerter (herefter PLP). Selvom eksisterende terapier i nogle tilfælde giver smertelindring, er der bred enighed om, at de nuværende tilgange ikke kan bringe lindring til de fleste personer med PLP (Weeks et al., 2010).
Efterforskerne afsluttede for nylig et proof-of-concept-studie (Ambron et al., 2021), hvor otte forsøgspersoner med amputationer under knæet (BKA) gennemgik to virtual reality-behandlinger (VR) for PLP. I en Active VR-behandling spillede forsøgspersoner en række aktive spil, der krævede benbevægelser, mens de modtog visuel feedback af høj kvalitet af det manglende underben. Feedback om benposition blev givet via et elektromagnetisk system ved hjælp af bensensorer (trackSTAR, Ascension Technologies Inc), og programmet genererede et billede af det manglende underben, synligt som en førstepersons avatar. Denne behandling blev kontrasteret med en "Distractor"-behandling, hvor deltagerne var engageret i en visuelt fordybende virtual reality-oplevelse, der ikke krævede benbevægelser (Cool!TM). Begge behandlinger var forbundet med signifikante reduktioner i smerteintensitet, men Active VR-behandlingen var også forbundet med reduktioner i smerteinterferens, depression og angst.
De specifikke mål med den aktuelle undersøgelse er (i) at gentage vores tidligere observationer af effektiviteten af VR-behandling i et større udvalg af individer med BKA; (ii) at teste VR-terapi hos patienter med amputationer over knæet; (iii) at sammenligne effektiviteten af Active VR-behandling med Distractor VR-behandling for PLP på mål for smerte samt psykologisk sundhed og livskvalitet.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
46
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
Elkins Park, Pennsylvania, Forenede Stater, 19027
- Moss Rehabilitation Research Institute
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98104
- University of Washington-Harborview Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Alder 18 - 100 år
- Kapacitet til at give informeret samtykke
- Ensidig amputation over eller under knæet mere end 3 måneder før indskrivning
- Fravær af kognitiv svækkelse, operationelt defineret som en Montreal Cognitive Assessment-score på 24 eller derover
- Smerter i gennemsnit over den foregående 1 måned i fantomlemmet vurderet til at være større end 40 på den visuelle analoge skala i McGill Pain Questionnaire (Melzack, 1987)
Ekskluderingskriterier:
- Anamnese med betydelig medicinsk eller neurologisk lidelse såsom slagtilfælde eller moderat til svær traumatisk hjerneskade (operationelt defineret som bevidsthedstab i mere end 30 minutter)
- Anamnese med betydelige eller dårligt kontrollerede psykiatriske lidelser
- Aktuel signifikant depression eller angst som bedømt af Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983).
- Aktuelt misbrug af alkohol eller stoffer, receptpligtig eller andet
- At amme et barn, være gravid eller have til hensigt at blive gravid under undersøgelsen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Active VR treatment
Subjects assigned to the Active VR treatment began by selecting an avatar, with features such as gender and skin color that could be chosen according to preference.
During treatment, they participated in a variety of games and activities developed and used by our teams including Kick, Dog Food, Quest for Fire, Chess, Checkers, Sudoku, and surfing the internet.
Subjects had substantial flexibility to select games according to their interests but were required to spend at least 30 minutes in each session in games that required forceful, large-amplitude movements of the amputated lower limb (e.g., Quest for Fire, Kick).
|
8 twice-weekly interventions of virtual reality treatment focused on reducing phantom limb pain.
|
|
Eksperimentel: Distractor VR treatment
Subjects assigned to the Distractor VR treatment participated in the REAL i-Series immersive VR experience (REAL system), which had been demonstrated to reduce pain in several studies but lacked the hypothesized "active ingredients" of our Active VR treatment (visual and auditory feedback of movement of an extrapolated amputated limb).
Subjects navigated through pleasant and relaxing VR environments; they did not see any rendering of their body and made no movements with their legs.
|
8 twice-weekly interventions of virtual reality treatment focused on reducing phantom limb pain.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Pain Intensity
Tidsramme: Baseline versus immediately post-intervention at 4 weeks.
|
Visual Analogue Scale (VAS) of McGill Short Form Questionnaire (Melzack, 1987); 0 minimum score - 10 maximum score; higher scores indicate higher level of pain (worse outcome)
|
Baseline versus immediately post-intervention at 4 weeks.
|
|
Changes in Pain Quality
Tidsramme: Baseline versus immediately post-intervention at 4 weeks.
|
McGill Short Form Questionnaire (Melzack, 1987): a series of 4-point scales (0 none - 3 severe) assessing the intensity of 15 qualitative characteristics of pain (e.g., throbbing, shooting, cramping, etc.), where higher scores are worse (more severe).
For every participant we computed the total pain score (maximum 45 points indicating severe pain).
Then, we computed the difference in the total scores between time points (e.g.
post treatment vs baseline).
Therefore, negative scores indicate improvement in pain qualitative characteristics.
|
Baseline versus immediately post-intervention at 4 weeks.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Average Pain
Tidsramme: 1st treatment versus 8th treatment (4 weeks)
|
Difference between 8th and 1st treatment session on scaled score measuring "average pain intensity since the previous intervention" on an 11-point numerical rating pain scale; (Scale = 0 - minimum score/no pain to 10 maximum score/pain as bad as participants can imagine); higher scores indicate higher level of pain (worse outcome).
|
1st treatment versus 8th treatment (4 weeks)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Daily Activities
Tidsramme: Baseline versus immediately post-intervention at 4 weeks.
|
The Frenchay Activities Index (FAI) (Holbrook et al., 1983):1983): a scale measuring the physical function and daily activity associated with quality of life in people with amputation.
Scale = 0 minimum score to 45 maximum score; higher scores indicate more daily activities (better outcome).
We report the average difference between post-intervention (after 4 weeks) and pre-intervention.
|
Baseline versus immediately post-intervention at 4 weeks.
|
|
Changes in Quality of Life
Tidsramme: Baseline versus immediately post-intervention at 4 weeks.
|
The 12-Item Short Form Health Survey (SF-12) (Ware et al., 1996): a measure of quality of life and functional capacity that has been validated in patients with amputation and phantom limb pain.
Scale = 0 minimum score to 100 maximum score.
Higher scores indicate poorer physical and mental health (worse outcome).
|
Baseline versus immediately post-intervention at 4 weeks.
|
|
Changes in Pain Interference
Tidsramme: Baseline versus immediately post-intervention at 4 weeks
|
The Pain Interference Scale from the Brief Pain Inventory (BPI) (Cleeland & Ryan, 1994): A scale measuring the degree to which pain interferes with daily activities using a 0-10 numeric rating.
Scale = 0 minimum score to 10 maximum score.
Higher scores indicate greater pain interference (worse outcome).
We report the average difference between post-intervention (after 4 weeks) and pre-intervention.
|
Baseline versus immediately post-intervention at 4 weeks
|
|
Changes in Depression and Anxiety
Tidsramme: Baseline versus immediately post-intervention at 4 weeks.
|
The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983): This is a 14- item measure with subscales assessing depressive and anxiety symptoms.
For each subscale.
range = 0 minimum score to 42 maximum score.
Higher scores indicate more depression and/or anxiety (worse outcome).
We report average differences on the anxiety scale and the depression scales between post-intervention (after 4 weeks) and pre-intervention.
|
Baseline versus immediately post-intervention at 4 weeks.
|
|
Changes in Pain Catastrophizing
Tidsramme: Baseline versus immediately post-intervention at 4 weeks.
|
The 13-item Pain Catastrophizing Scale (Sullivan et al., 1995): this scale investigates pain catastrophizing, which has been associated with pain severity and disability after amputation.
Score range = 0-52; Higher scores indicate higher tendency to catastrophize (worse outcome).
We report the average difference between post-intervention (after 4 weeks) and pre-intervention.
|
Baseline versus immediately post-intervention at 4 weeks.
|
|
Changes in Insomnia
Tidsramme: Baseline versus immediately post-intervention at 4 weeks.
|
Insomnia Severity Index (Bastien et al., 2001): a 7-point scale that measures insomnia, a symptom associated with phantom limb pain.
Score range = 0-28; higher scores indicate more insomnia (worse outcome).
We report the average difference between post-intervention (after 4 weeks) and pre-intervention.
|
Baseline versus immediately post-intervention at 4 weeks.
|
|
Acceptance of VR System
Tidsramme: Baseline
|
Technology Acceptance Scale (Morris et al., 1997): this is a 7-point scale that measures level of acceptance of the VR system.
0 minimum score - 133 maximum score; higher scores indicate low level of acceptance (worse score).
|
Baseline
|
|
Usability of the Treatment
Tidsramme: immediately after the last intervention (session 8 of the intervention), an average of 4 weeks
|
System Usability Scale (SUS) (Brooke, 1996); Scale measuring the usability of the each game; minimum score 10 - maximum score 50.
Higher scores indicate less usability (worse outcome).
For the distractor treatment, participants rated the overall experience; for the active treatment, the average of the two games was computed for each participants.
|
immediately after the last intervention (session 8 of the intervention), an average of 4 weeks
|
|
Cybersickness
Tidsramme: 1st (week 1) and 8th (week 4) treatment sessions
|
Simulator Sickness Questionnaire - SSQ (Kennedy et al., 1993): 4 points (0 - none; 3 - severe) scale assessing the severity of 16 cybersickness motion sickness symptoms, like nausea or dizziness.
We computed the average score across items.
|
1st (week 1) and 8th (week 4) treatment sessions
|
|
Presence in VR
Tidsramme: 1st (week 1) and 8th (week 4) treatment sessions.
|
Brief Slater-Usoh-Steed Presence Questionnaire (Usoh et al., 2000; Slater et al., 1998; 1994).
0 minimum score - 42 maximum score.
Higher scores indicate more presence in the VR (better outcome
|
1st (week 1) and 8th (week 4) treatment sessions.
|
|
Changes in Pain at Its Worst
Tidsramme: Baseline versus immediately post-intervention at 4 weeks
|
The Modified Limb Deficiency and Phantom Limb Questionnaire (Goller et al., 2013): a questionnaire and visual analog scale assessing prosthesis usage, phantom limb experiences, and pain severity.
The outcome measure used was the score on the visual analogue scale assessing pain severity at its worst (Scale = 0 no pain to 10 unbearable pain).
We report the average score difference between post-intervention (after 4 weeks) and pre-intervention.
|
Baseline versus immediately post-intervention at 4 weeks
|
|
Treatment Satisfaction
Tidsramme: 1 week after the end of the intervention, an average of 5 weeks
|
Visual analogue scale that evaluates treatment satisfaction (Robinson et al., 2004; Smith et al., 2005); 0 minimum score - 10 maximum score; Higher scores indicate more treatment satisfaction (better outcome)
|
1 week after the end of the intervention, an average of 5 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Laurel Buxbaum, PsyD, Albert Einstein Healthcare Netork
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Robinson LR, Czerniecki JM, Ehde DM, Edwards WT, Judish DA, Goldberg ML, Campbell KM, Smith DG, Jensen MP. Trial of amitriptyline for relief of pain in amputees: results of a randomized controlled study. Arch Phys Med Rehabil. 2004 Jan;85(1):1-6. doi: 10.1016/s0003-9993(03)00476-3.
- Smith DG, Ehde DM, Hanley MA, Campbell KM, Jensen MP, Hoffman AJ, Awan AB, Czerniecki JM, Robinson LR. Efficacy of gabapentin in treating chronic phantom limb and residual limb pain. J Rehabil Res Dev. 2005 Sep-Oct;42(5):645-54. doi: 10.1682/jrrd.2005.05.0082.
- Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.
- Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.
- Slater M, Steed A, McCarthy J, Maringelli F. The influence of body movement on subjective presence in virtual environments. Hum Factors. 1998 Sep;40(3):469-77. doi: 10.1518/001872098779591368.
- Ambron E, Buxbaum LJ, Miller A, Stoll H, Kuchenbecker KJ, Coslett HB. Virtual Reality Treatment Displaying the Missing Leg Improves Phantom Limb Pain: A Small Clinical Trial. Neurorehabil Neural Repair. 2021 Dec;35(12):1100-1111. doi: 10.1177/15459683211054164. Epub 2021 Oct 27.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. maj 2022
Primær færdiggørelse (Faktiske)
16. marts 2025
Studieafslutning (Faktiske)
6. april 2025
Datoer for studieregistrering
Først indsendt
9. februar 2022
Først indsendt, der opfyldte QC-kriterier
24. marts 2022
Først opslået (Faktiske)
25. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2022-775.
- 5R01HD104158-05 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Efter afidentifikation vil individuelle deltagerdata, der skal deles, omfatte beskrivelser af klinisk status (f.eks. tid siden amputation, amputationsniveau), baggrundstestbatteriresultater og resultatmålresultater.
IPD-delingstidsramme
Umiddelbart efter udgivelsen.
Ingen slutdato.
IPD-delingsadgangskriterier
Forskere, der giver en god begrundelse.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .