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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Université de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Yannick Tousignant-Laflamme, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01960400
First received: September 24, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Complex Regional Pain Syndrome Type 1 (CRPS)
Device: tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Efficacy of Transcranial Direct Current Stimulation (tDCS) Added to the Graded Motor Imagery (GMI) in the Treatment of Complex Regional Pain Syndrome (CRPS) Type 1

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • The global impression of change [ Time Frame: after end of treatment, 1 and 3 months follow-up ] [ Designated as safety issue: No ]
    Patient Global Impression of Change


Secondary Outcome Measures:
  • The clinical pain and global physical function [ Time Frame: after end of treatment, 1 and 3 months follow-up ] [ Designated as safety issue: Yes ]
    short form Brief Pain Inventory

  • The perception of the specific function of the upper limb [ Time Frame: after end of treatment, 1 and 3 months follow-up ] [ Designated as safety issue: No ]
    Disabilities of the Arm, Shoulder and Hand questionnaire on functional disability

  • The perception of the specific function of the lower limb [ Time Frame: after end of treatment, 1 and 3 months follow-up ] [ Designated as safety issue: No ]
    Lower extremity version of the Impairment Sum Score

  • The impact of pain on health-related quality of life [ Time Frame: after end of treatment, 1 and 3 months follow-up ] [ Designated as safety issue: No ]
    sf-12


Other Outcome Measures:
  • Cortical reorganization [ Time Frame: before and 3 months after the treatment ] [ Designated as safety issue: Yes ]
    Each participant will undergo MRI / fMRI examinations. MRI will enable us to obtain high-resolution images of the various brain structures, which will provide information regarding both cortical thickness and the density of the white and grey matter. fMRI will capture images while the subject is performing a motor activity with the affected limb and will be compared to the opposite (healthy) hemisphere. These images will be reconstructed to highlight the activation sites throughout the brain. These will allow us to measure how brain structures and function are changed following tDCS and GMI treatments, and whether these cortical alterations correlate to the observed clinical changes at post-intervention.


Estimated Enrollment: 28
Study Start Date: April 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GMI + tDCS
Graded motor imagery (GMI) + tDCS
Device: 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.
Other Name: Transcranial direct current stimulation
Placebo Comparator: GMI + sham TDCS
Graded motor imagery (GMI) + sham tDCS

Detailed Description:

Executive summary: The efficacy of the current standard rehabilitation treatments for complex regional pain syndrome (CRPS), a painful syndrome mostly occurring after musculoskeletal trauma, is suboptimal. For instance, the first line of treatment in rehabilitation, progressive motor imagery (GMI), only induces a 50% improvement in symptoms. Although such improvement is interesting, further solutions should be sought to enhance clinical outcomes. It is thus essential to explore new options of therapy. A potential solution to enhance clinical outcomes would be to add an electrotherapeutic procedure, such as transcranial direct current stimulation (tDCS). Given the positive results previously obtained in patients with neuropathic pain, we hypothesize that tDCS will induce functional and structural reorganization in the cortex and lead to better pain relief. The cortical reorganization frequently observed in CRPS patients mainly involves a shrinkage of cortical map of the affected limb on primary and secondary somatosensory cortex. Interestingly, therapies that aim to reverse the cortical reorganization are often associated with a decrease in pain. Therefore, combining GMI and tDCS could lead to added pain relief compared to traditional GMI treatments alone. Furthermore, neuroimaging before and after the procedures could help us explain if and how this is achieved. Objectives: Thus, the primary objective of this research is to study the therapeutic efficacy of tDCS in the treatment of CRPS type 1 in addition to the current best evidence-based rehabilitation treatment, GMI. The second objective is to study, through MRI/fMRI, how brain structures and functions are changed following tDCS and GMI treatments, and whether these changes correlate to clinical changes.

Methodology: To achieve the first objective, we will recruit adults diagnosed with CRPS type 1 via established collaborations with different physicians from our university affiliated hospital. Participants will be randomly allocated into one of the two treatment groups A) experimental group, which will receive the GMI and tDCS stimulation; B) control group, which will receive GMI and sham [placebo] tDCS stimulation. GMI treatment is composed of a three-phase protocol, each lasting two weeks. The GMI treatments 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. Sample size estimates (β:80%,α 5%) show that 15 subjects/group will be necessary.

Anticipated results and impact of the proposed project: This project will allow us to investigate the therapeutic efficacy of an innovative approach to the treatment of CRPS, primarily for the purpose of enhancing the clinical outcomes of GMI. In the event of positive results, we will be able to further examine the therapeutic benefits of this modality in a larger clientele and even in other populations (i.e., patients with chronic low back pain). In addition, our results may contribute to the creation of a clinical practice guide, since there currently is insufficient evidence-based data to establish guidelines regarding the non-pharmacological treatment of CRPS. Finally, MRI/fMRI analysis will help us to capture the phenomenon of tDCS-driven cortical reorganization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960400

Contacts
Contact: Emilie Lagueux, O.T. Ph.D(c) 819-346-1110 ext 12436 emilie.lagueux@usherbrooke.ca

Locations
Canada, Quebec
Recruiting
Sherbrooke, Quebec, Canada
Contact: Emilie Lagueux, O.T. Ph.D(c)    819-346-1110 ext 12436    emilie.lagueux@usherbrooke.ca   
Principal Investigator: Yannick Tousignant-Laflamme, Ph.D.         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Yannick Tousignant-Laflamme, PhD Université de Sherbrooke
Principal Investigator: Patricia Bourgault, PhD Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Yannick Tousignant-Laflamme, PT Ph.D., Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01960400     History of Changes
Other Study ID Numbers: 12-116
Study First Received: September 24, 2013
Last Updated: October 8, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
Complex regional pain syndrome type 1 (CRPS)
Transcranial direct current stimulation (tDCS)
Graded motor imagery (GMI)
Magnetic resonance imaging (MRI)
Functional magnetic resonance imaging (fMRI)

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Syndrome
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014