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Light Irradiation and Outcome for Neuropathic Pain

NCT03228160 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-05-04

No results posted yet for this study

Summary

Background. Sympathetically maintained pain (SMP) can be effectively relieved by light irradiation to the area near stellate ganglion (SGI), which is applied as an alternative to sympathetic blockade. The clinical efficiency of SGI on heart rate variability (HRV) and its association with pain outcome need to be further identified.

Objectives. This study is aimed to identify the effects of SGI on pain, HRV indices, quality of life, and function outcomes.

Design. A prospective, double blind, randomized designed study Setting. An outpatient pain medicine clinic Subjects and Methods. A total of 44 patients will be enrolled and randomized to their allocations: the experimental group (EG, n=22) and control group (CG, n=22). All patients in EG will receive 12 sessions (twice a week) of standard SGI, while those in CG go through the same protocol except a shame irradiation is applied. Pain, HRV variables, quality of life, and function outcoms are measured before and after SGI in each session. All measures at the first-half and second-half courses are analyzed.

Conditions

  • Complex Regional Pain Syndrome

Interventions

OTHER

Linearly Polarized Near-Infrared light Irradiation

The SGI was carried out with the use of a linear-polarized near-infrared irradiation device, Minato Alphabeam Infrared Ray Therapy Unit (Minato Medical Science Co., Ltd., Hyogo, Japan), by a senior physical therapist. The maximum output was 3000 mW/cm² at wavelengths of 0.7 to 1.6 m-⁶, including a combination of red and near-infrared radiation. All patients in the experimental group received SGI under the conditions as follows: output, 90%; irradiation circle 1:2 (irradiation 3 seconds followed by 7-seconds pause); duration of irradiation, 10 min; and total irradiation energy density, 194.8 J/cm². The instrument in the control group with shame irradiation was the same as that in the experimental group with the exception that emitted radiation from device was inactive.

Sponsors & Collaborators

  • Taipei Medical University Shuang Ho Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2022-12-01
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228160 on ClinicalTrials.gov