An interventional study of transcranial Direct Current Stimulation (tDCS) and Mirror therapy in Phantom Limb Pain, sponsored by Loewenstein Hospital. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-29.
Sponsored by Loewenstein Hospital · Not applicable, Interventional, and Treatment
In this study we will examine assess if treatment with transcranial Direct Current Stimulation (tDCS) improve the analgesic effects of mirror therapy for patients with phantom pain of lower extremity. The study will include 3 arms: only mirror therapy, mirror therapy + sham tDCS, and mirror therapy + active tDCS.
Phantom pain following amputation is difficult to treat, resulting in many patients who suffer. One of the mechanisms suspected to contribute to phantom pain is abnormal plasticity and reorganization of the cortex.
Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
It was hypothesize that combination of mirror therapy and tDCS treatment could result in additive effects. According to this hypothesis, the effects of the mirror therapy could be enhanced by the tDCS treatment. The aim of the current study is to investigate this hypothesis.
150 studies on the registry are indexed under Phantom Limb; 40 are open to participants now.
This study's planned enrollment of 60 is above the median of 28 across 115 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Loewenstein Hospital is the lead sponsor of 24 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be asked to perform specific movements (using the unaffected limb while watching its mirrored reflection for 20 minutes per day, for 10 treatment days, completed during two weeks (every weekday, excluding weekends)
Other: Mirror therapy
Subject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, a sham tDCS treatment will be applied.
Device: transcranial Direct Current Stimulation (tDCS) · Other: Mirror therapy
Subject will undergo the mirror therapy treatment, as in the first study arm. In addition, at the same time, an active tDCS treatment will be applied.
Device: transcranial Direct Current Stimulation (tDCS) · Other: Mirror therapy
tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
The Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) of the average Phantom Limb Pain in the past week will serve as primary measure. The primary outcome is the changes in the VAS score between baseline week and 4 weeks after the end of the treatment. VAS is a widely used, continuous measure of pain intensity, with scores ranging between 0-10, higher scores reflecting higher pain intensity.
Time frame: between baseline week and 4 weeks after the end of the treatment
McGill total score
Changes in short-form McGill total score between baseline week and 4 weeks after the end of the treatment. The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain. Scores are tabulated by summing values associated with each word. The short-form McGill Pain Questionnaire (SF-MPQ) is a shorter version of the original MPQ. The pain rating index has 2 subscales: 1. Sensory subscale with 11 words, and 2. Affective subscale with 4 words from the original MPQ. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity.
Time frame: between baseline week and 4 weeks after the end of the treatment
McGill sensory sub-score
Changes in short-form McGill sensory sub-score between baseline week and 4 weeks after the end of the treatment. The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain. Scores are tabulated by summing values associated with each word. The short-form McGill Pain Questionnaire (SF-MPQ) is a shorter version of the original MPQ. The pain rating index has 2 subscales: 1. Sensory subscale with 11 words, and 2. Affective subscale with 4 words from the original MPQ. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity.
Time frame: between baseline week and 4 weeks after the end of the treatment
Changes in the worst pain
Changes in the worst pain over the past week (taken from the Brief Pain Inventory (BPI questionnaire) between baseline week and 4 weeks after the end of the treatment. The scale rapidly assesses the severity of pain and its impact on functioning. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
Time frame: between baseline week and 4 weeks after the end of the treatment
Changes in the average pain
Changes in the average pain over the past week (taken from the Brief Pain Inventory (BPI questionnaire) between baseline week and 4 weeks after the end of the treatment. The scale rapidly assesses the severity of pain and its impact on functioning. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
Time frame: between baseline week and 4 weeks after the end of the treatment
Changes in the VAS score
Changes in the VAS score between baseline week and 12 weeks after the end of the treatment. VAS is a widely used, continuous measure of pain intensity, with scores ranging between 0-10, higher scores reflecting higher pain intensity.
Time frame: between baseline week and 12 weeks after the end of the treatment
Changes in short-form McGill total score
Changes in short-form McGill total score between baseline week and 12 weeks after the end of the treatment. The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain. Scores are tabulated by summing values associated with each word. The short-form McGill Pain Questionnaire (SF-MPQ) is a shorter version of the original MPQ. The pain rating index has 2 subscales: 1. Sensory subscale with 11 words, and 2. Affective subscale with 4 words from the original MPQ. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity.
Time frame: between baseline week and 12 weeks after the end of the treatment
Changes in short-form McGill sensory sub-score
Changes in short-form McGill sensory sub-score between baseline week and 12 weeks after the end of the treatment. The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain. Scores are tabulated by summing values associated with each word. The short-form McGill Pain Questionnaire (SF-MPQ) is a shorter version of the original MPQ. The pain rating index has 2 subscales: 1. Sensory subscale with 11 words, and 2. Affective subscale with 4 words from the original MPQ. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity.
Time frame: between baseline week and 12 weeks after the end of the treatment
Changes in the worst pain
Changes in the worst pain over the past week (taken from the Brief Pain Inventory (BPI questionnaire) between baseline week and 12 weeks after the end of the treatment. The scale rapidly assesses the severity of pain and its impact on functioning. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
Time frame: between baseline week and 12 weeks after the end of the treatment
Changes in the average pain
Changes in the average pain over the past week (taken from the Brief Pain Inventory (BPI questionnaire) between baseline week and 12 weeks after the end of the treatment. The scale rapidly assesses the severity of pain and its impact on functioning. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
Time frame: between baseline week and 12 weeks after the end of the treatment
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Loewenstein Hospital