Effects of Pain Scrambler Therapy for the Alterations of Cerebral Blood
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedJune 20, 2019
June 1, 2019
1.2 years
March 5, 2019
June 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
neuropathic pain score
visual analog scale, Zero ("0") represented no pain and 10 represented unbearable symptoms
after 4 weeks scrambler therapy
Secondary Outcomes (1)
Cerebral blood volume
after 4 weeks scrambler therapy
Study Arms (2)
scarmbler treatment group
EXPERIMENTALEach 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.
sham treatment group
SHAM COMPARATORconservative management without scarmbler therapy
Interventions
Scrambler therapy is a patient-specific electrocutaneous nerve stimulation device.
Eligibility Criteria
You may qualify if:
- Burn patients
- severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hangang Sacred Heart Hospital
Seoul, Yeong-deungpo-Dong, 150-719, South Korea
Related Publications (3)
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.
PMID: 27756587BACKGROUNDMajithia 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.
PMID: 27041741RESULTLee 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.
PMID: 35893347DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheong Hoon Seo, M.D.
Hangang Sacred Heart Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2019
First Posted
March 7, 2019
Study Start
July 1, 2019
Primary Completion
August 31, 2020
Study Completion
November 30, 2020
Last Updated
June 20, 2019
Record last verified: 2019-06