Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood

Pain, Neuropathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03865693
• Other study ID #: HangangSHH-3
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2019
• Source: Hangang Sacred Heart Hospital
• Contact: Cheong Hoon Seo, M.D.
• Phone: +82 2 2639 5738
• Email: chseomd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Pain, Neuropathic

Intervention

Device:
• scarmbler therapy
Scrambler therapy is a patient-specific electrocutaneous nerve stimulation device.

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul	Yeong-deungpo-Dong

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropathic pain score	visual analog scale, Zero ("0") represented no pain and 10 represented unbearable symptoms	after 4 weeks scrambler therapy
Secondary	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.	after 4 weeks scrambler therapy