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Phantom Limb PainNCT03112928

Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP

A study testing Phantom Motor Execution and Phantom Motor Imagery in people with Phantom Limb Pain, run by Integrum at 9 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Phantom Limb Pain
What is being tested?
Phantom Motor Execution and Phantom Motor Imagery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
9 sitesin 7 countries
Study dates
8 May 2017to 20 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • Subject must be older than 18 years.
  • If the subjects are under pharmacological treatments, there must be no variations on the medicament dosages for at least one month (steady consumption).
  • The last session of previous treatments must be at least 3 months old.
  • Any pain reduction potentially attributed to previous phantom limb pain treatments must be at least 3 months old.
  • Subjects must have control over at least a portion of biceps and triceps muscles for upper limb amputations, and quadriceps and hamstrings for the lower limb amputations.
  • The subject has signed a written informed consent.
  • The subject must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis) or being a non user.
  • At least six months should be passed since the amputation: acute phantom limb pain cases should not be included in the study.
  • The patient subject should not have a significant cognitive impairment that prevents the patient from following instructions.
  • Subjects with abundant soft tissue on their stump will not be automatically excluded, however, an evaluation in the system is required to analyze if sufficient electromyography signals can be recorded.
  • Subjects for whom skin contact or muscle contraction are painful (NRS > 2) are not eligible for the study.
  • The subject should not have any condition associated with risk of poor protocol compliance.
  • The subject should not have any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgement.

Trial locations and contacts

9 sites in 7 countries.

9 sites in 7 countries

Sweden3 sites

  • Gåskolan, Ortopedtekniska avdelningen

    Gothenburg, Västergötland, 41285

  • Ortopedteknik, Region Örebro län

    Örebro, Närke, 701 16

  • Bräcke Diakoni

    Stockholm, Uppland, 17078

Other trials in Sweden

United States1 site

  • Shirley Ryan Ability Lab

    Chicago, Illinois, 60611

Other trials in United States

Canada1 site

  • Institue of Biomedical Engineering, University of New Brunswick

    Fredericton, New Brunswick, E3B 5A3

Other trials in Canada

Germany1 site

  • Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr - University Bochum (RUB)

    Bochum

Other trials in Germany

Ireland1 site

  • School of Psychology, National University of Ireland

    Galway, Connacht

Other trials in Ireland

Netherlands1 site

  • University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine

    Groningen, 9700 RB

Other trials in Netherlands

Slovenia1 site

  • University Rehabilitation Institute

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Phantom Motor Execution Via Myoelectric Pattern Recognition, Virtual and Augmented Reality, and Serious Gaming as a Treatment of Phantom Limb Pain

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.

Read the detailed description

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).

Being tested
Phantom Motor Execution, Phantom Motor Imagery
Medical subject headings
Phantom Limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phantom Motor ExecutionDevice

    Also called Neuromotus - PME

    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:

    1. Pain evaluation
    2. Placement of the electrodes and fiducial marker
    3. Practice of motor execution in Augmented Reality (AR)
    4. Gaming using phantom movements
    5. Practice of motor execution by matching random target postures of a virtual limb.

    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.

  • Phantom Motor ImageryDevice

    Also called Neuromotus - PMI

    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.

Study groups in NCT03112928
Study groupRoleWhat they receive
Phantom Motor Execution (PME)ExperimentalPhantom motor execution is decoded via myoelectric pattern recognition and promoted via serious gaming in virtual and augmented reality.
Receives: Device: Phantom Motor Execution
Phantom Motor Imagery (PMI)Active comparatorUse 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.
Receives: Device: Phantom Motor Imagery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28-40 weeks, depending on the frequency of the sessions.

Secondary outcomes (1)

  1. 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.

    Measured: 28-40 weeks, depending on the frequency of the sessions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start8 May 2017
  3. Primary completion12 Mar 2021
  4. Study completion20 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
International, multi-centre, double-blind, randomized, controlled clinical trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03112928
Sponsor's protocol ID
007733
Status last verified
Sep 2020
First submitted
10 Apr 2017
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27916234

  • 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.

    PubMed 24616655

  • 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.

    PubMed 39250328

  • 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.

    PubMed 35152915

  • 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.

    PubMed 30012784

Questions about this trial

What is this clinical trial studying?

A study testing Phantom Motor Execution and Phantom Motor Imagery in people with Phantom Limb Pain, run by Integrum at 9 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Sweden, United States, Canada, Germany, Ireland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session). (time frame: 28-40 weeks, depending on the frequency of the sessions.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03112928, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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