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Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood

Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood Volume in Pain Network of Neuropathic Pain on Burn Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03865693
Enrollment
40
Registered
2019-03-07
Start date
2019-07-01
Completion date
2020-11-30
Last updated
2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Neuropathic

Keywords

Burn, pain scrambler

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.

Interventions

DEVICEscarmbler therapy

Scrambler therapy is a patient-specific electrocutaneous nerve stimulation device.

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Hangang Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
neuropathic pain scoreafter 4 weeks scrambler therapyvisual analog scale, Zero (0) represented no pain and 10 represented unbearable symptoms

Secondary

MeasureTime frameDescription
Cerebral blood volumeafter 4 weeks scrambler therapyCerebral 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.

Countries

South Korea

Contacts

Primary ContactCheong Hoon Seo, M.D.
chseomd@gmail.com+82 2 2639 5738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026