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Assessing Possible Additive Effects of tDCS and Mirror Therapy Treatments for Phantom Pain

Primary Purpose

Phantom Limb Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Mirror therapy
Sponsored by
Loewenstein Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 or older
  2. Underwent unilateral lower limb amputation in the past 3 months. A
  3. Reported average phantom pain of 4 or more in the past week.
  4. No change in other medications 1 week prior to enrollment, not including SOS.
  5. Able understand the purpose of the study and to provide informed consent.

Exclusion Criteria:

1. Ferromagnetic metal in the head or neck.

  1. Epilepsy or prior seizures within the last 1 year.
  2. Suffering from severe depression
  3. History of unexplained fainting or loss of consciousness

Sites / Locations

  • Loewenstein HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Experimental

Arm Label

Mirror therapy

Mirror therapy + sham tDCS

Mirror therapy + active tDCS

Arm Description

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)

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 26, 2019
Last Updated
August 27, 2019
Sponsor
Loewenstein Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04071275
Brief Title
Assessing Possible Additive Effects of tDCS and Mirror Therapy Treatments for Phantom Pain
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 22, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loewenstein Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mirror therapy
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Mirror therapy + sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Mirror therapy + active tDCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Visual Analog Scale (VAS)
Description
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
Secondary Outcome Measure Information:
Title
McGill total score
Description
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
Title
McGill sensory sub-score
Description
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
Title
Changes in the worst pain
Description
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
Title
Changes in the average pain
Description
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
Title
Changes in the VAS score
Description
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
Title
Changes in short-form McGill total score
Description
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
Title
Changes in short-form McGill sensory sub-score
Description
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
Title
Changes in the worst pain
Description
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
Title
Changes in the average pain
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nitza Segal, M.A
Phone
9729542471155
Email
nitza@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Roi Treister, PhD
Phone
972-533-839935
Email
rtreister@univ.haifa.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitza Segal, M.A
Organizational Affiliation
Leowenstein Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Loewenstein Hospital
City
Ra'anana
ZIP/Postal Code
43100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitza Segal, M.A.
Phone
972542471155
Email
nitza@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing Possible Additive Effects of tDCS and Mirror Therapy Treatments for Phantom Pain

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