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Investigation of the Efficacy of tDCS in the Treatment of Complex Regional Pain Syndrome (CRPS) Type 1

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ClinicalTrials.gov Identifier: NCT01960400
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : November 16, 2016
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yannick Tousignant-Laflamme, Université de Sherbrooke

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Reflex Sympathetic Dystrophy
Interventions Device: transcranial direct current stimulation (tDCS) (active or placebo)
Device: Graded motor imagery (GMI)
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GMI + tDCS GMI + Sham TDCS
Hide Arm/Group Description

Graded motor imagery (GMI) + tDCS

tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization.

Graded motor imagery (GMI) + sham tDCS

tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization.

Period Title: Overall Study
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title GMI + tDCS GMI + Sham TDCS Total
Hide Arm/Group Description

Graded motor imagery (GMI) + tDCS

tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization.

Graded motor imagery (GMI) + sham tDCS

tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization.

Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
10
  90.9%
21
  95.5%
>=65 years
0
   0.0%
1
   9.1%
1
   4.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
40.91  (10.76) 52.83  (12.81) 46.87  (13.06)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
8
  72.7%
6
  54.5%
14
  63.6%
Male
3
  27.3%
5
  45.5%
8
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Pain Severity
Hide Description

The choice of outcome measures was performed in accordance with Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) guidelines (Dworkin et al., 2005). All instruments were used before (T0) and after 6 weeks of treatment (T1).

The primary outcome measure was pain severity as measured with the Brief pain inventory short-form (BPI-sf) (Poundja et al., 2007). The BPI-sf includes four questions on pain levels, where subjects were asked to rate intensity on a scale of 0 (no pain) to 10 (worst possible pain) for: (1) pain at its worst in the last 24 hours; (2) pain at its least in the last 24 hours; (3) pain on average in the last 24 hours; (4) pain right now. The total score ranges from 0 to 40 (sum of the four subscales). The higher the score, the greater the severity of the pain is severe.

Time Frame Before (T0) and after treatment (6 weeks) (T1)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS + GMI Placebo tDCS + GMI
Hide Arm/Group Description:

tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.

tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes.

tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).

tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes.

Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Before treatment (T0) 22.18  (7.43) 23.36  (6.19)
After treatment (T1) 18.00  (9.20) 23.82  (5.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active tDCS + GMI, Placebo tDCS + GMI
Comments For the severity of pain, the calculations have revealed that only this pain now had an acceptable statistical power, of 77.1% after treatment (T1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments

The statistical signifiance level : p<0.05. After treatment (T1) Pain severity p=0.065

Sub-scale:

  • Present pain p=0.046*
  • Average pain p=0.381
  • Most intense pain p=0.064
  • Least intense pain p=0.142
Method ANOVA
Comments To assess the effectiveness of interventions (inter-group differences), a mixed-model ANOVA (time X group interaction) was used.
2.Secondary Outcome
Title Pain Catastrophizing
Hide Description

The Pain catastrophizing scale (PCS) (Sullivan et al., 1995) was used to evaluate the feelings, thoughts, and emotions related to pain catastrophizing of the patient. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness.

* The scores ranging from 0 to 52 points (sum of the tree subscales), with higher scores representing stronger pain catastrophizing (Sullivan et al., 1995).

Time Frame Before (T0) and after treatment (6 weeks) (T1)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS + GMI Placebo tDCS + GMI
Hide Arm/Group Description:

tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.

tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes.

tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).

tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes.

Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Before treatment (T0) 24.09  (10.98) 27.64  (10.36)
After treatment (T1) 16.64  (10.68) 25.91  (11.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active tDCS + GMI, Placebo tDCS + GMI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments interaction group X time
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Kinesiophobia
Hide Description The Tampa Scale of kinesiophobia (TSK) (Kori et al., 1990) was used to assess fear of movement and injury/(re)injury. The TSK questionnaires consist of 17 items. Each item, composed of a statement, is scored by the patient on a 4-point Likert scale of 1 (strongly disagree) to 4 (strongly agree). The total scores range from 17 to 68, with higher scores representing stronger fear-avoidance beliefs (Clark, Kori, Brockel, 1996).
Time Frame Before (T0) and after treatment (6 weeks) (T1)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS + GMI Placebo tDCS + GMI
Hide Arm/Group Description:

tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.

tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes.

tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).

tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes.

Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Before treatment (T0) 44.09  (8.60) 42.55  (8.59)
After treatment (T1) 40.36  (8.23) 42.82  (8.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active tDCS + GMI, Placebo tDCS + GMI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments interaction group X time
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title State Anxiety
Hide Description The State-Trait Anxiety Inventory (STAI) was used to assess the state of anxiety at the moment (Spielberg et al., 1983). The total score is obtained by adding the scores for all 20 questions range from 20 to 80; the higher the result is, the higher is the anxiety about an event.
Time Frame Before (T0) and after treatment (6 weeks) (T1)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS + GMI Placebo tDCS + GMI
Hide Arm/Group Description:

tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.

tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes.

tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).

tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes.

Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Before treatment (T0) 41.91  (14.43) 41.91  (17.61)
After treatment (T1) 35.91  (12.19) 44.00  (15.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active tDCS + GMI, Placebo tDCS + GMI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments interaction group X time
Method ANOVA
Comments [Not Specified]
Time Frame Adverse events were collected each week of the intervention (six weeks). A questionnaire on adverse effects was done after six weeks of treatment (T1). No follow-up was done after the end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GMI + Active tDCS GMI + Placebo tDCS
Hide Arm/Group Description Graded motor imagery (GMI) + active tDCS Graded motor imagery (GMI) + placebo tDCS
All-Cause Mortality
GMI + Active tDCS GMI + Placebo tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GMI + Active tDCS GMI + Placebo tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/11 (45.45%)      3/11 (27.27%)    
Musculoskeletal and connective tissue disorders     
Fasciculation *  1/11 (9.09%)  1 0/11 (0.00%)  0
Nervous system disorders     
Light headache *  3/11 (27.27%)  3 2/11 (18.18%)  2
Skin and subcutaneous tissue disorders     
Increase pain   5/11 (45.45%)  5 3/11 (27.27%)  3
Burning sensation *  4/11 (36.36%)  4 3/11 (27.27%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GMI + Active tDCS GMI + Placebo tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Yannick Tousignant-Laflamme
Organization: Université de Sherbrooke
Phone: 819-821-8000 ext 72912
Responsible Party: Yannick Tousignant-Laflamme, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01960400     History of Changes
Other Study ID Numbers: 12-116
First Submitted: September 24, 2013
First Posted: October 10, 2013
Results First Submitted: October 28, 2015
Results First Posted: November 16, 2016
Last Update Posted: February 6, 2017