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

NCT01960400 | Completed Results DMC

• 1 other identifier: 12-116
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reflex Sympathetic Dystrophy

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Pain Severity

  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.

  Before (T0) and after treatment (6 weeks) (T1)

Secondary Outcomes (3)

• Pain Catastrophizing

  Before (T0) and after treatment (6 weeks) (T1)

• Kinesiophobia

  Before (T0) and after treatment (6 weeks) (T1)

• State Anxiety

  Before (T0) and after treatment (6 weeks) (T1)

Study Arms (2)

GMI + tDCS

ACTIVE COMPARATOR

Graded motor imagery (GMI) + tDCS

Device: transcranial direct current stimulation (tDCS) (active or placebo); Device: Graded motor imagery (GMI)

GMI + sham TDCS

PLACEBO COMPARATOR

Graded motor imagery (GMI) + sham tDCS

Device: transcranial direct current stimulation (tDCS) (active or placebo); Device: Graded motor imagery (GMI)

Interventions

transcranial direct current stimulation (tDCS) (active or placebo) DEVICE

TDCS was delivered according to the method described by Fregni et al. (2006) and the safety parameters related to tDCS application were respected (DaSilva et al., 2011). Direct current was delivered using a battery-driven constant current stimulator coupled to saline-soaked (0.9% NaCl) sponge electrodes (5 X 7 cm). Anodal stimulation was delivered over the M1; the anode was placed over C3 or C4 position in the 10/20 system for the EEG electrode position, contralateral to the affected limb, and the cathode over the opposite supraorbital area (i.e. ipsilateral to the affected limb). In the laboratory, a constant current of an intensity of 2 mA was applied for 20 min/day X 5 consecutive days during the first and the second weeks of GMI. To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.

Also known as: Transcranial direct current stimulation

GMI + sham TDCS; GMI + tDCS

Graded motor imagery (GMI) DEVICE

The treatment was performed using a software (Recognise™ online) provided by NOI group (http://www.noigroup.com/recognise). As an alternative to the software (for patients without an internet access), the patient could do the exercises with a Recognise™ Flash Cards set consists of 25 left and 25 right matching images (upper limb or lower limb). Using standardized procedures, inspired from the randomized controlled trial conducted by Moseley (2004, 2006), the participants performed the therapy at home, 10 minutes per session, 3x/day, 6 days/week, using the computer software and a mirror box (Lagueux et al., 2012).

GMI + sham TDCS; GMI + tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults diagnosed with CRPS type 1, based on Bruehl's diagnostic criteria for research.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Unknown Facility

Sherbrooke, Quebec, Canada

Location

MeSH Terms

Conditions

Reflex Sympathetic Dystrophy; Complex Regional Pain Syndromes

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr Yannick Tousignant-Laflamme
• Organization: Université de Sherbrooke

Yannick.Tousignant-Laflamme@USherbrooke.ca

819-821-8000

Study Officials

• Yannick Tousignant-Laflamme, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Patricia Bourgault, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT Ph.D.

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 10, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 6, 2017
• Results First Posted: November 16, 2016

Record last verified: 2016-12

Locations

CA (1)