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Phantom Limb Pain clinical trials

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NCT ID: NCT02784548 Completed - Phantom Limb Pain Clinical Trials

Virtual Reality for Phantom Limb Pain

Start date: October 2, 2017
Phase: N/A
Study type: Interventional

This study will develop a virtual reality-based treatment for phantom limb pain among Veterans and test it against the most established behavioral therapy for phantom limb pain, mirror therapy.

NCT ID: NCT02589080 Completed - Phantom Limb Pain Clinical Trials

Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis

EPIONE
Start date: January 2015
Phase: N/A
Study type: Interventional

Amputation of a limb may result from trauma or surgical intervention. The amputation traumatically alters the body image, but often leaves sensations that refer to the missing body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain (PLP). Both peripheral and central nervous system factors have been implicated as determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and psychological factors (emotional stress). Recent evidence suggests that PLP may be intricately related to neuroplastic changes in the cortex, and that these changes may modulated by providing sensory input to the stump or amputation zone. A non-invasive clinical trial will test the effectiveness of non-invasive pressure sensory feedback build into a hand prosthesis to alleviate phantom limb pain.

NCT ID: NCT02569918 Completed - Phantom Limb Pain Clinical Trials

Use of Hand Prosthesis With Surface Electrical Stimulation for Treatment of Phantom Limb Pain

EPIONE
Start date: February 2015
Phase: N/A
Study type: Interventional

Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective. Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback. The aim of the proposed research is to create natural, meaningful sensations through providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.

NCT ID: NCT02519907 Active, not recruiting - Phantom Limb Pain Clinical Trials

Surface Electrical Stimulation for Treatment of Phantom Limb Pain

EPIONE
Start date: September 2015
Phase: N/A
Study type: Interventional

Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective. Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback. The aim of the proposed research is to create natural, meaningful sensations through providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.

NCT ID: NCT02506608 Completed - Phantom Limb Pain Clinical Trials

Use of Hand Prosthesis With Direct Nerve Stimulation for Treatment of Phantom Limb Pain

EPIONE
Start date: June 2015
Phase: N/A
Study type: Interventional

Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective. Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback. The aim of the proposed research is to create natural, meaningful sensations through providing sensory feedback (i.e. surface or neural electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.

NCT ID: NCT02496351 Recruiting - Clinical trials for Peripheral Vascular Diseases

TENS for Phantom Limb Pain Prevention Following Major Amputation

Start date: May 2015
Phase: N/A
Study type: Interventional

A growing body of literature indicates that up to 80% of amputees may have phantom limb pain (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. The etiology and pathophysiology of PLP are poorly understood. Some studies suggest a somatosensory cortex reorganization. Transcutaneous Electrical Nerve Stimulation (TENS) is a analgesic technique. TENS apply a low voltage electrical current through the skin using surface electrodes in order to stimulate afferent nerve fibbers. Because of the lack of evidence to support any treatment for PLP, interest has turned to preventing it instead. The aim of this study is to assess if the early use of TENS in the immediately postoperative of major limb amputation due to peripheral vascular disease, should decrease the PLP incidence. TENS should interfere in the mechanism of PLP production to level of the pain fibers conduction.

NCT ID: NCT02493842 Recruiting - Phantom Limb Pain Clinical Trials

Direct Nerve Stimulation for Treatment of Phantom Limb Pain

EPIONE
Start date: June 2015
Phase: N/A
Study type: Interventional

Background: Phantom limb pain (PLP) develops in 50-80% of subjects who have a limb amputated. It is not well known what causes PLP to develop and the current treatments have been shown to be largely ineffective. Resent research, however, have indicated that cortical reorganizing occurring after amputation of the cortex areas related to the missing limb may be related to the development of PLP. Furthermore, the research indicated that by providing meaningful sensory input coming from the phantom limb the PLP may be alleviated and the cortical organization normalized. Aim: The CIP described in the current application, is part of a the EU-project "EPIONE", which aims to investigate if and how cortical normalization and PLP alleviation can be induced by providing phantom limb sensations (sensations which seems to originate from the missing limb) in hand amputated subjects. Method: In the current study, which will take place at Aalborg University Hospital (AUH), 2-4 hand amputated subjects experiencing severe PLP will implanted with interneural nerve electrodes in the arm stump for up to one year. Therapy will be evaluated in two stages, first during a standardized four week phase where the subject receives daily therapy. If the therapy is shown to be effective, therapy may be reinitiated during a second longer therapy phase. During the therapy sessions, selective nerve stimulation will be performed. The amputee will experience this as sensations (movement, touch, temperature, vibration etc.) originating from the phantom limb. While implanted, we will investigate how well we can induce these sensations and we will provide a stimulation therapy, which consist of stimulation activities which requires the subject to focus on the evoked sensations. Prior to, during a and following therapy a series of assessments (standardized across all EPIONE partners to enable comparison) will be conducted to relate therapy with PLP, cortical organization, the mental state etc. of the subject. Expected outcome: The stimulation therapy is expected to alleviate PLP and induce cortical normalization. The experience we gain might be used for deriving clinical guidelines on how to treat PLP.

NCT ID: NCT02488668 Completed - Phantom Limb Pain Clinical Trials

Surface Electrical Stimulation for Treatment of Phantom Limb Pain

EPIONE
Start date: June 2015
Phase: N/A
Study type: Interventional

Phantom limb pain (PLP) is a frequent consequence of amputation, and it is notoriously difficult to treat. Amputation usually follows traumatic injuries or surgery following vascular diseases, diabetes, osteomyelitis or tumours in cases where the loss of the limb is required for the survival of the patient. The loss of a limb or other body parts is usually followed by the sensation that the lost body part is still present and can be felt. These phenomena are called, respectively, phantom awareness and phantom sensation. In 50-80% of amputees neuropathic pain develops in the lost limb also referred to as phantom limb pain (PLP). PLP can be related to a certain position or movement of the phantom limb, and might be elicited or worsened by a range of physical factors (e.g. changes in the weather or pressure on the residual limb) and psychological factors (e.g. emotional stress). It is well known that most treatments available for PLP today, such as pharmacological, surgical, anaesthetic, psychological and other, are ineffective. Today it is believed that phantom limb pain may be related to changes in the cortex of the brain. There is evidence that these changes may be modulated - or even reversed - by providing sensory input to the stump or amputation zone. For example, cortical reorganization and alleviation of phantom limb pain has been observed in amputees following intense use of a hand prosthesis. However, there is no consistent knowledge on which type of peripheral sensory feedback may be effective in affecting the cortical plasticity or on how to best apply the sensory feedback. The aim of the proposed research is to create natural, meaningful sensations through providing non-invasive sensory feedback (i.e. surface electrical stimulation) and the effectiveness to alleviate phantom limb pain and restore the cortical neuroplastic changes.

NCT ID: NCT02487966 Active, not recruiting - Phantom Limb Pain Clinical Trials

Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)

Start date: July 2015
Phase: N/A
Study type: Interventional

This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham tDCS and sham MT (covered mirror).

NCT ID: NCT02383979 Recruiting - Phantom Limb Pain Clinical Trials

Perioperative Mirror Therapy and Phantom Limb Pain

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Mirror therapy will consist of observing the unaffected limb reflected in a mirror positioned in the midline to block the view of the affected limb. All therapy sessions will be supervised by a physical therapist with the exception of weekends when the patients will continue therapy on an independent basis. In an effort to objectively demonstrate cortical reorganization associated with mirror therapy, patients can elect to participate in a functional MRI (fMRI) portion of the study. The fMRI would be evaluated prior to initiating the experimental or control therapy (Due to the sensitive timeline in this population and its effect on recruitment, we have amended the protocol to allow recruitment and enrollment to take place even if the timeline does not allow for the fMRI to be executed 2 weeks prior to amputation. Though this would be ideal, we will accept subjects that are only available for day before amputation scans), just before the operative procedure, at four weeks post-operation and then again at one year. All subjects will be evaluated at 4 weeks, 8 weeks (functional physical therapy (PT) tests only) 12 weeks, and 12 months postoperatively to determine 1) the incidence, severity and functional impact of phantom limb pain 2)the ability to meet various specialists' endpoints, to include participation in physical therapy, and 3) overall quality of life which the patients can describe subjectively. This therapy could have a dramatic impact on the long term prognosis of amputees whether due to trauma, metabolic conditions, tumor, or peripheral vascular disease. This protocol will include performing fMRIs on a cohort of healthy, active duty, age matched, male personnel to create reference data to compare the fMRI data of study participants.