NCT05052736

Brief Summary

Complex Regional Pain Syndrome (CRPS) / Complex Regional Pain Syndrome (CRPS) is a chronic neurological disorder that affects the extremities and is characterized by disabling pain, swelling, vasomotor instability, sudomotor abnormality, and impaired motor function; the duration and clinical magnitude is greater than expected, being divided into three stages of progression over time: Stage I: acute (0-3 months); Stage II: dystrophic (3-9 months); Stage 3: atrophic (9-18 months). The purpose of this study is to investigate the effect on complex pain syndrome using a conventional care protocol plus the application of non-invasive neuromodulation during compared to the effect of the same protocol plus placebo.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2022Dec 2026

First Submitted

Initial submission to the registry

September 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2026

Expected
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

September 12, 2021

Last Update Submit

August 21, 2025

Conditions

Type I Complex Regional Pain Syndrome

Keywords

physical therapy modalityElectric Stimulation Therapypain

Outcome Measures

Primary Outcomes (2)

  • Pain ( VAS)

    The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS). Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".

    Up to 6 month

  • Quick Dash Test

    The Quick DASH Upper Extremity Rating Scale for Upper Extremity can be completed by the patient in aid of the orthopedic surgeon. It consists of 11 items that assess the presence of symptoms and the functional capacity of the individual surveyed during the last week. A total of 11 questions must be answered for the questionnaire to calculate the functional situation accurately

    Up to 6 month

Secondary Outcomes (2)

  • Muscle balance

    Up to 6 month

  • Sleep quality

    Up to 6 month

Study Arms (2)

Non-invasive Neuromodulation

EXPERIMENTAL

Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

PLACEBO COMPARATOR

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.

Device: Non-invasive Neuromodulation

Interventions

Non-invasive NeuromodulationDEVICE

The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 20 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 millivolt and intensity 0.5 μA.

Non-invasive NeuromodulationPlacebo Non-invasive Neuromodulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the Budapest criteria for the clinical diagnosis of CRPS type I.
  • Age between 18 and 65.
  • Period between 0 and 6 months after the onset of the clinical picture.
  • Have signed the informed consent of their own free will.

You may not qualify if:

  • Have a diagnosis of CRPS type II.
  • Present type I CRPS in more than one limb.
  • Patients who have suffered a recurrence of CRPS type I.
  • Pregnancy or plans for it during the study.
  • Previous sympathectomy in the affected limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aníbal Báez Suárez

Las Palmas de Gran Canaria, Palmas, Las, 35016, Spain

RECRUITING

Related Publications (8)

  • Sebastin SJ. Complex regional pain syndrome. Indian J Plast Surg. 2011 May;44(2):298-307. doi: 10.4103/0970-0358.85351.

    PMID: 22022040RESULT

  • Wasner G, Schattschneider J, Binder A, Baron R. Complex regional pain syndrome--diagnostic, mechanisms, CNS involvement and therapy. Spinal Cord. 2003 Feb;41(2):61-75. doi: 10.1038/sj.sc.3101404.

    PMID: 12595868RESULT

  • Todorova J, Dantchev N, Petrova G. Complex regional pain syndrome acceptance and the alternative denominations in the medical literature. Med Princ Pract. 2013;22(3):295-300. doi: 10.1159/000343905. Epub 2012 Nov 16.

    PMID: 23171669RESULT

  • Bruehl S. An update on the pathophysiology of complex regional pain syndrome. Anesthesiology. 2010 Sep;113(3):713-25. doi: 10.1097/ALN.0b013e3181e3db38.

    PMID: 20693883RESULT

  • Ratti C, Nordio A, Resmini G, Murena L. Post-traumatic complex regional pain syndrome: clinical features and epidemiology. Clin Cases Miner Bone Metab. 2015 Jan-Apr;12(Suppl 1):11-6. doi: 10.11138/ccmbm/2015.12.3s.011. Epub 2016 Apr 7.

    PMID: 27134626RESULT

  • Sandroni P, Benrud-Larson LM, McClelland RL, Low PA. Complex regional pain syndrome type I: incidence and prevalence in Olmsted county, a population-based study. Pain. 2003 May;103(1-2):199-207. doi: 10.1016/s0304-3959(03)00065-4.

    PMID: 12749974RESULT

  • Elsamadicy AA, Yang S, Sergesketter AR, Ashraf B, Charalambous L, Kemeny H, Ejikeme T, Ren X, Pagadala P, Parente B, Xie J, Lad SP. Prevalence and Cost Analysis of Complex Regional Pain Syndrome (CRPS): A Role for Neuromodulation. Neuromodulation. 2018 Jul;21(5):423-430. doi: 10.1111/ner.12691. Epub 2017 Sep 29.

    PMID: 28961359RESULT

  • Albazaz R, Wong YT, Homer-Vanniasinkam S. Complex regional pain syndrome: a review. Ann Vasc Surg. 2008 Mar;22(2):297-306. doi: 10.1016/j.avsg.2007.10.006.

    PMID: 18346583RESULT

MeSH Terms

Conditions

Reflex Sympathetic DystrophyPain

Condition Hierarchy (Ancestors)

Complex Regional Pain SyndromesAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aníbal Báez-Suárez, PhD

    University of Las Palmas de Gran Canaria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aníbal Báez-Suárez, PhD

CONTACT

+34 652077692anibal.baez@ulpgc.es

Aníbal Báez-Suárez, PhD

CONTACT

+34652077692anibal.baez@ulpgc.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2021

First Posted

September 22, 2021

Study Start

March 28, 2022

Primary Completion

April 27, 2026

Study Completion (Estimated)

December 27, 2026

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations

ES(1)