Non Invasive Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)

January 29, 2024 updated by: Aníbal Báez Suárez, University of Las Palmas de Gran Canaria

Effectiveness and Safety of NXsignal Applied Surface Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The design of this study is a randomised, triple blind clinical trial with placebo control.

The size of the sample will be 42 participants who come to referral hospitals. They will be randomized in two groups: control or experimental.

The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention.

The variables of the study will be collected at two time points: before the intervention and at the end of the intervention.

The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p <0.05

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Palmas, Las
      • Las Palmas De Gran Canaria, Palmas, Las, Spain, 35016
        • Recruiting
        • Aníbal Báez Suárez
        • Sub-Investigator:
          • Raquel Medina Ramirez, PhD
        • Contact:
        • Principal Investigator:
          • Roque González Díez, PhD
        • Sub-Investigator:
          • Eloisa Navarro Gonzalez, PhD
        • Sub-Investigator:
          • Pilar Loscos Gil, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-invasive Neuromodulation
Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Device: Non-invasive Neuromodulation

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain ( VAS)
Time Frame: Up to 6 month

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
Time Frame: Up to 6 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle balance
Time Frame: Up to 6 month

The Daniels scale or Daniels test is a tool used to measure the strength of muscles in the human body, especially in patients with neuromuscular disorders or localized injuries.

the scale itself follows a specific numbering, with six well-differentiated levels from 0 to 5. These are the following:

0: the muscle does not contract, complete paralysis.

  1. the muscle contracts, but there is no movement. The contraction can be palpated or visualized, but there is no movement.
  2. the muscle contracts and performs all the movement, but without resistance, since it cannot overcome gravity.
  3. the muscle can carry out the movement against gravity as the only resistance.
  4. the muscle contracts and performs the full movement, in full range, against gravity and against moderate manual resistance.
  5. the muscle contracts and performs the movement in full range against gravity and with maximum manual resistance
Up to 6 month
Sleep quality
Time Frame: Up to 6 month

The Medical Outcomes Study Sleep Scale questionnaire will be used. This instrument was designed to obtain subjective information on the quality and quantity of sleep in the last 4 weeks. It is composed of 12 Likert-type items with 6 degrees of response (from 1-always to 6-never) and grouped into the following categories:

  • Sleep disturbances
  • snoring
  • Waking up with shortness of breath or headache
  • Amount of sleep
  • Adequacy of sleep
  • Daytime sleepiness

For its interpretation, a gross estimate of the amount of sleep is obtained (item 2) and scores in the different subscales. The direct scores are transformed into a scale from 0 to 100, with no cut-off points; the higher the score, the greater the intensity of the concept evaluated.
Up to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Las Palmas de Gran Canaria

Investigators

  • Principal Investigator: Aníbal Báez-Suárez, PhD, University of Las Palmas de Gran Canaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

April 27, 2024

Study Completion (Estimated)

December 27, 2024

Study Registration Dates

First Submitted

September 12, 2021

First Submitted That Met QC Criteria

September 12, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NESAMAZ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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