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

Primary Purpose

Type I Complex Regional Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non-invasive Neuromodulation
Sponsored by
University of Las Palmas de Gran Canaria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type I Complex Regional Pain Syndrome focused on measuring physical therapy modality, Electric Stimulation Therapy, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aníbal Báez SuárezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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".
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

Secondary Outcome Measures

Muscle balance
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. the muscle contracts, but there is no movement. The contraction can be palpated or visualized, but there is no movement. the muscle contracts and performs all the movement, but without resistance, since it cannot overcome gravity. the muscle can carry out the movement against gravity as the only resistance. the muscle contracts and performs the full movement, in full range, against gravity and against moderate manual resistance. the muscle contracts and performs the movement in full range against gravity and with maximum manual resistance
Sleep quality
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.

Full Information

First Posted
September 12, 2021
Last Updated
August 3, 2023
Sponsor
University of Las Palmas de Gran Canaria
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1. Study Identification

Unique Protocol Identification Number
NCT05052736
Brief Title
Non Invasive Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)
Official Title
Effectiveness and Safety of NXsignal Applied Surface Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
October 27, 2023 (Anticipated)
Study Completion Date
April 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Las Palmas de Gran Canaria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Complex Regional Pain Syndrome
Keywords
physical therapy modality, Electric Stimulation Therapy, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-invasive Neuromodulation
Arm Type
Experimental
Arm Description
Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
Arm Title
Placebo Non-invasive Neuromodulation
Arm Type
Placebo Comparator
Arm Description
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7.
Intervention Type
Device
Intervention Name(s)
Non-invasive Neuromodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain ( VAS)
Description
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".
Time Frame
Up to 6 month
Title
Quick Dash Test
Description
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
Time Frame
Up to 6 month
Secondary Outcome Measure Information:
Title
Muscle balance
Description
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. the muscle contracts, but there is no movement. The contraction can be palpated or visualized, but there is no movement. the muscle contracts and performs all the movement, but without resistance, since it cannot overcome gravity. the muscle can carry out the movement against gravity as the only resistance. the muscle contracts and performs the full movement, in full range, against gravity and against moderate manual resistance. the muscle contracts and performs the movement in full range against gravity and with maximum manual resistance
Time Frame
Up to 6 month
Title
Sleep quality
Description
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.
Time Frame
Up to 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aníbal Báez-Suárez, PhD
Phone
+34 652077692
Email
anibal.baez@ulpgc.es
First Name & Middle Initial & Last Name or Official Title & Degree
Aníbal Báez-Suárez, PhD
Phone
+34652077692
Email
anibal.baez@ulpgc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aníbal Báez-Suárez, PhD
Organizational Affiliation
University of Las Palmas de Gran Canaria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aníbal Báez Suárez
City
Las Palmas De Gran Canaria
State/Province
Palmas, Las
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aníbal Báez Suárez, PhD
Phone
652077692
Email
anibal.baez@ulpgc.es
First Name & Middle Initial & Last Name & Degree
Roque González Díez, PhD
First Name & Middle Initial & Last Name & Degree
Eloisa Navarro Gonzalez, PhD
First Name & Middle Initial & Last Name & Degree
Pilar Loscos Gil, PhD
First Name & Middle Initial & Last Name & Degree
Raquel Medina Ramirez, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22022040
Citation
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Results Reference
result
PubMed Identifier
12595868
Citation
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.
Results Reference
result
PubMed Identifier
23171669
Citation
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.
Results Reference
result
PubMed Identifier
20693883
Citation
Bruehl S. An update on the pathophysiology of complex regional pain syndrome. Anesthesiology. 2010 Sep;113(3):713-25. doi: 10.1097/ALN.0b013e3181e3db38.
Results Reference
result
PubMed Identifier
27134626
Citation
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.
Results Reference
result
PubMed Identifier
12749974
Citation
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.
Results Reference
result
PubMed Identifier
28961359
Citation
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.
Results Reference
result
PubMed Identifier
18346583
Citation
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.
Results Reference
result

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

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