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| Name | Class |
|---|---|
| Chalmers University of Technology | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Örebro University, Sweden | OTHER |
| Bräcke Diakoni, Sweden |
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This international, multi-center, double-blind, randomized, controlled clinical trial aims to evaluate the efficacy of Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as treatments of Phantom Limb Pain (PLP). In PME, myoelectric pattern recognition (MPR) is used to predict motor volition and then use the decoded movements to control virtual and augmented reality environments (VR/AR), along with serious gaming (SG). The same device and VR/AR environments are used in PMI with the difference that subjects will imagine rather than execute phantom movements. Electromyography is used to monitor for no muscular activity in PMI.
Sixty-six subjects with upper or lower limb amputations are planned to take part in this study. Subjects will be assigned randomly to PME and PMI treatments (2:1 proportion). After treatment completion (15 sessions of 2 hours each) and follow-up period of six months, patients that received PMI will be given the choice to receive PME. The design is double blinded as the patient will be informed that the treatment received, regardless of which, has been shown effective in previous studies. The person conducting the pain evaluations will be blinded to which treatment each patient receives, and will not take part on providing treatment (evaluator and therapist are different persons).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phantom Motor Execution (PME) | Experimental | Phantom motor execution is decoded via myoelectric pattern recognition and promoted via serious gaming in virtual and augmented reality. |
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| Phantom Motor Imagery (PMI) | Active Comparator | Use the same device and visual stimulation as PME, with the difference that participants imagine to perform, rather than execute phantom movements. Myoelectric activity is used to monitor that the subjects do not produce muscular contractions but only imagine the movements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phantom Motor Execution | Device | Neuromotus - PME decodes motor volition applying machine learning to surface electromyography. Once the intention of movement is known, this is use to control serious games in virtual and augmented reality. A treatment session of MPE consists of:
Step 3 to 4 are repeated for different phantom joints, initially one at the time progressing to several joints simultaneously. A treatment session last 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session). | The Pain Rating Index (PRI) is calculated as the sum of 15 descriptors. At the end of each treatment session the descriptors are presented to the patient, who rates each of them with an intensity scale from 0 to 3. The PRI is therefore a number between 0 and 45: the higher the index the greater is the pain. The primary efficacy variable for this study is the change in PRI between the first and the last treatment session. | 28-40 weeks, depending on the frequency of the sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Disability Index registered at the beginning (1st session) and the end of the treatment (15th session). | The Pain Disability Index (PDI) measures the impact that pain has on the ability of a person to participate in essential life activities. The index is comprised between 0 and 70. The higher the index the greater the person's disability due to pain is. The secondary efficacy variable of this study is the change in PDI between the first and the last treatment session. |
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| Name | Affiliation | Role |
|---|---|---|
| Max Ortiz Catalan, PhD | Chalmers Technological University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan Ability Lab | Chicago | Illinois | 60611 | United States | ||
| Institue of Biomedical Engineering, University of New Brunswick |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27916234 | Background | Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2. | |
| 24616655 |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| UNKNOWN |
| University Rehabilitation Institute, Republic of Slovenia | OTHER |
| University Medical Center Groningen | OTHER |
| University of New Brunswick | OTHER |
| National University of Ireland, Galway, Ireland | OTHER |
| Shirley Ryan AbilityLab | OTHER |
| Ruhr University of Bochum | OTHER |
International, multi-centre, double-blind, randomized, controlled clinical trial
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Participants will be informed that both treatments have been shown effective in previous studies, and in the present study we are comparing their efficacy.
The person conducting the pain evaluation (outcomes assessor) will not treat the participants and will be unaware of which treatment is given to each participant. The person treating the subject is different than the person evaluating.
The principal and coordinating investigator will receive blinded data from all participating centers to analyze the clinical trial outcomes.
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| Phantom Motor Imagery | Device | The only difference between PME and PMI is that in the former myoelectric signals are used to give the participants control over the virtual environments, whereas in PMI the presence of myoelectric activity is used as an alarm to remind the participant that it must imagine rather than execute the phantom movement. In PMI the virtual environments act autonomously to guide the participant in imagination of movement. |
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| 28-40 weeks, depending on the frequency of the sessions. |
| Fredericton |
| New Brunswick |
| E3B 5A3 |
| Canada |
| Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr - University Bochum (RUB) | Bochum | Germany |
| School of Psychology, National University of Ireland | Galway | Connacht | Ireland |
| University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine | Groningen | 9700 RB | Netherlands |
| University Rehabilitation Institute | Ljubljana | 1000 | Slovenia |
| Ortopedteknik, Region Örebro län | Örebro | Närke | 701 16 | Sweden |
| Bräcke Diakoni | Stockholm | Uppland | 17078 | Sweden |
| Gåskolan, Ortopedtekniska avdelningen | Gothenburg | Västergötland | 41285 | Sweden |
| Background |
| Ortiz-Catalan M, Sander N, Kristoffersen MB, Hakansson B, Branemark R. Treatment of phantom limb pain (PLP) based on augmented reality and gaming controlled by myoelectric pattern recognition: a case study of a chronic PLP patient. Front Neurosci. 2014 Feb 25;8:24. doi: 10.3389/fnins.2014.00024. eCollection 2014. |
| 39250328 | Derived | Lendaro E, Van der Sluis CK, Hermansson L, Bunketorp-Kall L, Burger H, Keesom E, Widehammar C, Munoz-Novoa M, McGuire BE, O'Reilly P, Earley EJ, Iqbal S, Kristoffersen MB, Stockselius A, Gudmundson L, Hill W, Diers M, Turner KL, Weiss T, Ortiz-Catalan M. Extended reality used in the treatment of phantom limb pain: a multicenter, double-blind, randomized controlled trial. Pain. 2025 Mar 1;166(3):571-586. doi: 10.1097/j.pain.0000000000003384. Epub 2024 Sep 5. |
| 35152915 | Derived | Lendaro E, Earley EJ, Ortiz-Catalan M. Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain. Trials. 2022 Feb 13;23(1):138. doi: 10.1186/s13063-021-05962-7. |
| 30012784 | Derived | Lendaro E, Hermansson L, Burger H, Van der Sluis CK, McGuire BE, Pilch M, Bunketorp-Kall L, Kulbacka-Ortiz K, Rigner I, Stockselius A, Gudmundson L, Widehammar C, Hill W, Geers S, Ortiz-Catalan M. Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial. BMJ Open. 2018 Jul 16;8(7):e021039. doi: 10.1136/bmjopen-2017-021039. |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |