Trial Outcomes & Findings for Investigation of the Efficacy of tDCS in the Treatment of Complex Regional Pain Syndrome (CRPS) Type 1 (NCT NCT01960400)
NCT ID: NCT01960400
Last Updated: 2017-02-06
Results Overview
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.
COMPLETED
NA
22 participants
Before (T0) and after treatment (6 weeks) (T1)
2017-02-06
Participant Flow
Participant milestones
| Measure |
GMI + tDCS
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.
|
GMI + Sham TDCS
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of the Efficacy of tDCS in the Treatment of Complex Regional Pain Syndrome (CRPS) Type 1
Baseline characteristics by cohort
| Measure |
GMI + tDCS
n=11 Participants
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.
|
GMI + Sham TDCS
n=11 Participants
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
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
40.91 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
52.83 years
STANDARD_DEVIATION 12.81 • n=7 Participants
|
46.87 years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
|
Gender
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before (T0) and after treatment (6 weeks) (T1)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.
Outcome measures
| Measure |
Active tDCS + GMI
n=11 Participants
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.
|
Placebo tDCS + GMI
n=11 Participants
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.
|
|---|---|---|
|
Pain Severity
Before treatment (T0)
|
22.18 units on a scale
Standard Deviation 7.43
|
23.36 units on a scale
Standard Deviation 6.19
|
|
Pain Severity
After treatment (T1)
|
18.00 units on a scale
Standard Deviation 9.20
|
23.82 units on a scale
Standard Deviation 5.93
|
SECONDARY outcome
Timeframe: Before (T0) and after treatment (6 weeks) (T1)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).
Outcome measures
| Measure |
Active tDCS + GMI
n=11 Participants
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.
|
Placebo tDCS + GMI
n=11 Participants
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.
|
|---|---|---|
|
Pain Catastrophizing
Before treatment (T0)
|
24.09 units on a scale
Standard Deviation 10.98
|
27.64 units on a scale
Standard Deviation 10.36
|
|
Pain Catastrophizing
After treatment (T1)
|
16.64 units on a scale
Standard Deviation 10.68
|
25.91 units on a scale
Standard Deviation 11.42
|
SECONDARY outcome
Timeframe: Before (T0) and after treatment (6 weeks) (T1)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).
Outcome measures
| Measure |
Active tDCS + GMI
n=11 Participants
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.
|
Placebo tDCS + GMI
n=11 Participants
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.
|
|---|---|---|
|
Kinesiophobia
Before treatment (T0)
|
44.09 units on a scale
Standard Deviation 8.60
|
42.55 units on a scale
Standard Deviation 8.59
|
|
Kinesiophobia
After treatment (T1)
|
40.36 units on a scale
Standard Deviation 8.23
|
42.82 units on a scale
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: Before (T0) and after treatment (6 weeks) (T1)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.
Outcome measures
| Measure |
Active tDCS + GMI
n=11 Participants
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.
|
Placebo tDCS + GMI
n=11 Participants
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.
|
|---|---|---|
|
State Anxiety
Before treatment (T0)
|
41.91 units on a scale
Standard Deviation 14.43
|
41.91 units on a scale
Standard Deviation 17.61
|
|
State Anxiety
After treatment (T1)
|
35.91 units on a scale
Standard Deviation 12.19
|
44.00 units on a scale
Standard Deviation 15.38
|
Adverse Events
GMI + Active tDCS
GMI + Placebo tDCS
Serious adverse events
| Measure |
GMI + Active tDCS
n=11 participants at risk
Graded motor imagery (GMI) + active tDCS
|
GMI + Placebo tDCS
n=11 participants at risk
Graded motor imagery (GMI) + placebo tDCS
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Increase pain
|
45.5%
5/11 • Number of events 5 • 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.
|
27.3%
3/11 • Number of events 3 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fasciculation
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Nervous system disorders
Light headache
|
27.3%
3/11 • Number of events 3 • 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.
|
18.2%
2/11 • Number of events 2 • 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.
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
36.4%
4/11 • Number of events 4 • 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.
|
27.3%
3/11 • Number of events 3 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Yannick Tousignant-Laflamme
Université de Sherbrooke
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place