N/A
N=22
Investigation of the Efficacy of tDCS in the Treatment of Complex Regional Pain Syndrome (CRPS) Type 1
Reflex Sympathetic Dystrophy
Bottom Line
View on ClinicalTrials.gov: NCT01960400 ↗Enrolled (actual)
22
Serious AEs
36.4%
Results posted
Nov 2016
Primary outcome: Primary: Pain Severity — 22.18; 23.36; 18.00; 23.82 units on a scale — p=0.065
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial direct current stimulation (tDCS) (active or placebo) (Device); Graded motor imagery (GMI) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Université de Sherbrooke
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Severity |
22.18; 23.36; 18.00; 23.82 | 0.065 |
| SECONDARY Pain Catastrophizing |
24.09; 27.64; 16.64; 25.91 | 0.049 sig |
| SECONDARY Kinesiophobia |
44.09; 42.55; 40.36; 42.82 | 0.035 sig |
| SECONDARY State Anxiety |
41.91; 41.91; 35.91; 44.00 | 0.046 sig |
Summary
The efficacy of the current standard non-pharmacological treatments for complex regional pain syndrome (CRPS), a painful syndrome mostly occurring after musculoskeletal trauma, is suboptimal. It thus appears essential to examine new non-pharmacological therapeutic imagery (GMI) - a non-pharmacological approach with the highest level of evidence (level II). As suggested by the most recent clinical guideline 2, a potential solution would be to add an electrotherapeutic procedure - transcranial direct current stimulation (tDCS) - that may prove effective in modulating cortical excitability and reducing the effect of cortical reorganization on pain. Given the positive results previously obtained in patients with neuropathic pain, it is hypothesized that tDCS will prove to be an innovative add-on treatment method for CRPS patients, and help reduce pain and disability.
Eligibility Criteria
Inclusion Criteria
- Adults diagnosed with CRPS type 1, based on Bruehl's diagnostic criteria for research.
Exclusion Criteria
- Other painful conditions;
- Central nervous system disease;
- Other upper limb conditions;
- Diagnosis of psychiatric condition;
- Dyslexia and/or severe visual impairment;
- Presence of contraindication of tDCS (brain implant, history of severe cranial trauma, severe or frequent headaches, chronic skin conditions);
- Sympathetic blocks for less than one month;
- Pregnancy.
Data sourced from ClinicalTrials.gov (NCT01960400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.