Phantom Limb Pain Clinical Trial
Official title:
Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
Verified date | December 2023 |
Source | Spaulding Rehabilitation Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
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).
Status | Active, not recruiting |
Enrollment | 132 |
Est. completion date | December 21, 2024 |
Est. primary completion date | March 27, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Able to provide informed consent to participate in the study. 2. Subject is older than 18 years. 3. Unilateral lower limb amputation. 4. Traumatic amputation greater than 1 year ago. 5. Chronic PLP for at least 3 months previous to enrollment in the study, experienced regularly for at least once a week. 6. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10). 7. If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study. Exclusion Criteria: 1. Pregnancy or trying to become pregnant in the next 2 months. 2. History of alcohol or drug abuse within the past 6 months as self-reported. 3. Presence of the following contraindication to transcranial direct current stimulation and transcranial magnetic stimulation - Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) - Implanted neck or head electronic medical devices (e.g., cochlear implants, vagus nerve stimulator) 4. History of chronic pain previous to the amputation. 5. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported 6. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease). 7. Uncontrolled Epilepsy or prior seizures within the last 1 year. 8. Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).* 9. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years. 10. History of neurosurgery, as self-reported. 11. Mirror Therapy in the previous 3 months |
Country | Name | City | State |
---|---|---|---|
Brazil | IMREA HCFMUSP - Rede Lucy Montoro | São Paulo | |
United States | Spaulding Rehabilitation Network Research Institute | Charlestown | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Spaulding Rehabilitation Hospital | Massachusetts Eye and Ear Infirmary |
United States, Brazil,
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* Note: There are 74 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the Visual Analog Scale for Phantom Limb Pain | The primary endpoint will be the severity of pain measured by changes in PLP from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome. | 4 weeks | |
Secondary | Changes in the Visual Analog Scale for Stump Pain | The endpoint will be the severity of pain measured by changes in Stump Pain from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Stump Pain scale is a simple 10- point scale (0 = ''no Phantom Limb Stump Pain'', 10 = ''Phantom Limb Stump Pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome. | 4 weeks | |
Secondary | Changes in the Visual Analog Scale for Phantom Limb Sensation | The endpoint will be the severity of pain measured by changes in Phantom Limb Sensation from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Sensation scale is a simple 10- point scale (0 = ''no Phantom Limb Sensation'', 10 = ''Phantom Limb Sensation as much as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome. | 4 weeks |
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N/A | |
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VR to Evaluate Phantom Limb Pain
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Study of Lower-limb Phantom Pain Syndrome Using Peripheral Nerve and Spinal Cord Stimulation
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Prosthesis With Sensations
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N/A |