Phantom Limb PainNCT04071275
Assessing Possible Additive Effects of tDCS and Mirror Therapy Treatments for Phantom Pain
A study testing transcranial Direct Current Stimulation (tDCS) and Mirror therapy in people with Phantom Limb Pain, run by Loewenstein Hospital at 1 site in Israel.
Trial summary
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. 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?
- transcranial Direct Current Stimulation (tDCS) and Mirror therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Apr 2018to 30 Nov 2019
- 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
Who may be able to join
- Age 18 or older
- Underwent unilateral lower limb amputation in the past 3 months. A
- Reported average phantom pain of 4 or more in the past week.
- No change in other medications 1 week prior to enrollment, not including SOS.
- Able understand the purpose of the study and to provide informed consent.
Who cannot join
- 1. Ferromagnetic metal in the head or neck.
- Epilepsy or prior seizures within the last 1 year.
- Suffering from severe depression
- History of unexplained fainting or loss of consciousness
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Hospital
Raanana, 43100
Nitza Segal, M.A., 972542471155, nitza@clalit.org.il
About this study
Official title: Does Transcranial Direct Current Stimulation (tDCS) Improve the Effect of Mirror Therapy? A Double-blind Randomized Controlled Study in Patients With Phantom Limb Pain.
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.
Read the detailed description
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.
- Conditions
- Phantom Limb Pain
- Being tested
- transcranial Direct Current Stimulation (tDCS), Mirror therapy
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS)Device
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy | Active comparator | 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) Receives: Other: Mirror therapy |
| Mirror therapy + sham tDCS | Sham comparator | 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. Receives: Device: transcranial Direct Current Stimulation (tDCS); Other: Mirror therapy |
| Mirror therapy + active tDCS | Experimental | 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. Receives: Device: transcranial Direct Current Stimulation (tDCS); Other: Mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between baseline week and 4 weeks after the end of the treatment
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: between baseline week and 12 weeks after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start22 Apr 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagay Amir, Loewenstein Hospital
- Investigators
- Nitza Segal, M.A, Study chair, Leowenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071275
- Sponsor's protocol ID
- MOH_3107-2018-003552
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Transcranial Direct Current Stimulation (tDCS) Improve the Effect of Mirror Therapy? A Double-blind Randomized Controlled Study in Patients With Phantom Limb Pain.
- ClinicalTrials.gov ID
- NCT04071275
- Acronym / sponsor ID
- MOH_3107-2018-003552
- Conditions
- Phantom Limb Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 22 Apr 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy | Active comparator | Other: Mirror therapySubjects 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) |
| Mirror therapy + sham tDCS | Sham comparator | Device: transcranial Direct Current Stimulation (tDCS), Other: Mirror therapySubject 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. |
| Mirror therapy + active tDCS | Experimental | Device: transcranial Direct Current Stimulation (tDCS), Other: Mirror therapySubject 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Underwent unilateral lower limb amputation in the past 3 months. A
- Reported average phantom pain of 4 or more in the past week.
- No change in other medications 1 week prior to enrollment, not including SOS.
- Able understand the purpose of the study and to provide informed consent.
Key exclusion criteria (4 listed)
- 1. Ferromagnetic metal in the head or neck.
- Epilepsy or prior seizures within the last 1 year.
- Suffering from severe depression
- History of unexplained fainting or loss of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial Direct Current Stimulation (tDCS)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. | Device | Mirror therapy + active tDCS, Mirror therapy + sham tDCS |
| Mirror therapyMirror 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. | Other | Mirror therapy, Mirror therapy + active tDCS, Mirror therapy + sham tDCS |
Primary outcome
The Visual Analog Scale (VAS)
Time frame: between baseline week and 4 weeks after the end of the treatment
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.
9 secondary outcomes
McGill total score
Time frame: between baseline week and 4 weeks after the end of the treatment
McGill sensory sub-score
Time frame: between baseline week and 4 weeks after the end of the treatment
Changes in the worst pain
Time frame: between baseline week and 4 weeks after the end of the treatment
Changes in the average pain
Time frame: between baseline week and 4 weeks after the end of the treatment
Changes in the VAS score
Time frame: between baseline week and 12 weeks after the end of the treatment
Changes in short-form McGill total score
Time frame: between baseline week and 12 weeks after the end of the treatment
Changes in short-form McGill sensory sub-score
Time frame: between baseline week and 12 weeks after the end of the treatment
Changes in the worst pain
Time frame: between baseline week and 12 weeks after the end of the treatment
Changes in the average pain
Time frame: between baseline week and 12 weeks after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitza Segal, M.A study chair
Leowenstein Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation (tDCS) and Mirror therapy in people with Phantom Limb Pain, run by Loewenstein Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitza Segal, M.A (9729542471155, nitza@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analog Scale (VAS) (time frame: between baseline week and 4 weeks after the end of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2019.