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Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood

Primary Purpose

Pain, Neuropathic

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
scarmbler therapy
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Neuropathic focused on measuring Burn, pain scrambler

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Burn patients
  • severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS)

Exclusion Criteria:

  • cardiac arrest history
  • history of neurologi disease or brain surgery
  • unstable heart disease or presence of a cardiac pacemaker
  • pain resulting from other causes like as neuromuscular diseases
  • psychiatric disorder
  • diabetes mellitus
  • abnormal renal function
  • contraindication for MRI, or pregnancy.

Sites / Locations

  • Hangang Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

scarmbler treatment group

sham treatment group

Arm Description

Each Scrambler therapy with the MC5-A Calmare® therapy device (Competitive Technologies, Inc. Fairfield, USA ) was performed for 40 min daily (Monday through Friday) for 10 consecutive days. The experimental participants were received scarmbler therapy 10 times for 2 weeks. The stimulus was increased to the maximum intensity bearable by the individual patient without causing any additional pain or discomfort.

conservative management without scarmbler therapy

Outcomes

Primary Outcome Measures

neuropathic pain score
visual analog scale, Zero ("0") represented no pain and 10 represented unbearable symptoms

Secondary Outcome Measures

Cerebral blood volume
Cerebral blood volume(CBV) is a hemodynamic variable that is highly correlated with oxygen metabolism, representing the fraction of cerebral tissue volume occupied by blood at a given time point.

Full Information

First Posted
March 5, 2019
Last Updated
June 18, 2019
Sponsor
Hangang Sacred Heart Hospital
Collaborators
National Research Foundation of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03865693
Brief Title
Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood
Official Title
Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood Volume in Pain Network of Neuropathic Pain on Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
National Research Foundation of Korea

4. Oversight

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

5. Study Description

Brief Summary
Prevalence of chronic pain has been shown to be high after thermal injury. Post-burn neuropathic pain causes chronic disabilities that is often difficult to treat effectively. Pain Scrambler therapy is a patient-specific electrocutaneous nerve stimulation device. To study changes in the pain network associated with neuropathic pain, magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) in patients who had been injuried by burn. Participants (N=40, experimental 20 and control group 20) comprised patients with neuropathic pain after thermal injury. The subjects complained of severe neuropathic pain that was rated at least 5 on the visual analogue scale (VAS), despite treatments with gabapentin medication and other physical modalities. Each Scrambler therapy with the MC5-A Calmare® therapy device (Competitive Technologies, Inc. Fairfield, USA ) was performed for 40 min daily (Monday through Friday) for 10 consecutive days. The stimulus was increased to the maximum intensity bearable by the individual patient without causing any additional pain or discomfort. The intensity of neuropathic pain was measured using the visual analogue scale(VAS). Depressive mood was assessed using the Beck Depression Scale. Voxel-wise comparisons of relative CBV maps were made between before scrambler therapy and after 10 scrambler therapy sessions over the entire brain volume. The relationship between individual participant CBV(measured in voxels), BDS and VAS score was also examined. We observed decreased in the cerebral pain network of patients with burn injury. Scrambler therapy is a non-invasive, non-medicinal modality that significantly reduced burn-associated neuropathic pain. Scrambler therapy should be considered as a treatment option for burn survivors with severe neuropathic pain.
Detailed Description
The groups (scrambler therapy and sham therapy) were randomly assigned. All subjects were recruited in scrambler thrapy and sham stimulation. Main study outcomes included group differences in CBV changed and the the relationship between CBV changes and neuropathic pain intensity. These analyses were performed using the same framework of the general linear model, which was repeatedly applied to each voxel with the same coordinates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic
Keywords
Burn, pain scrambler

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
scarmbler treatment group
Arm Type
Experimental
Arm Description
Each Scrambler therapy with the MC5-A Calmare® therapy device (Competitive Technologies, Inc. Fairfield, USA ) was performed for 40 min daily (Monday through Friday) for 10 consecutive days. The experimental participants were received scarmbler therapy 10 times for 2 weeks. The stimulus was increased to the maximum intensity bearable by the individual patient without causing any additional pain or discomfort.
Arm Title
sham treatment group
Arm Type
Sham Comparator
Arm Description
conservative management without scarmbler therapy
Intervention Type
Device
Intervention Name(s)
scarmbler therapy
Intervention Description
Scrambler therapy is a patient-specific electrocutaneous nerve stimulation device.
Primary Outcome Measure Information:
Title
neuropathic pain score
Description
visual analog scale, Zero ("0") represented no pain and 10 represented unbearable symptoms
Time Frame
after 4 weeks scrambler therapy
Secondary Outcome Measure Information:
Title
Cerebral blood volume
Description
Cerebral blood volume(CBV) is a hemodynamic variable that is highly correlated with oxygen metabolism, representing the fraction of cerebral tissue volume occupied by blood at a given time point.
Time Frame
after 4 weeks scrambler therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Burn patients severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS) Exclusion Criteria: cardiac arrest history history of neurologi disease or brain surgery unstable heart disease or presence of a cardiac pacemaker pain resulting from other causes like as neuromuscular diseases psychiatric disorder diabetes mellitus abnormal renal function contraindication for MRI, or pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheong Hoon Seo, M.D.
Phone
+82 2 2639 5738
Email
chseomd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheong Hoon Seo, M.D.
Organizational Affiliation
Hangang Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
State/Province
Yeong-deungpo-Dong
ZIP/Postal Code
150-719
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheong Hoon Seo, M.D.
Phone
+82 2 2639 5738
Email
chseomd@gmail.com
First Name & Middle Initial & Last Name & Degree
So Young Joo, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
after review
Citations:
PubMed Identifier
27756587
Citation
Joo SY, Cho YS, Cho SR, Kym D, Seo CH. Effects of pain Scrambler therapy for management of burn scar pruritus: A pilot study. Burns. 2017 May;43(3):514-519. doi: 10.1016/j.burns.2016.09.028. Epub 2016 Oct 15.
Results Reference
background
PubMed Identifier
27041741
Citation
Majithia N, Smith TJ, Coyne PJ, Abdi S, Pachman DR, Lachance D, Shelerud R, Cheville A, Basford JR, Farley D, O'Neill C, Ruddy KJ, Sparadeo F, Beutler A, Loprinzi CL. Scrambler Therapy for the management of chronic pain. Support Care Cancer. 2016 Jun;24(6):2807-14. doi: 10.1007/s00520-016-3177-3. Epub 2016 Apr 4.
Results Reference
result
PubMed Identifier
35893347
Citation
Lee SY, Park CH, Cho YS, Kim L, Yoo JW, Joo SY, Seo CH. Scrambler Therapy for Chronic Pain after Burns and Its Effect on the Cerebral Pain Network: A Prospective, Double-Blinded, Randomized Controlled Trial. J Clin Med. 2022 Jul 22;11(15):4255. doi: 10.3390/jcm11154255.
Results Reference
derived

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Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood

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