Light Irradiation and Outcome for Neuropathic Pain

NCT03228160 | Unknown

• 1 other identifier: N201511030
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sympathetically Maintained Pain; Linear-Polarized Near-Infrared Irradiation; Stellate Ganglion; Heart Rate Variability; Autonomic Dysfunction Outcome

Outcome Measures

Primary Outcomes (2)

• Visual analogue scale (VAS: 0-100mm)

  A visual analogue scale (VAS: 0-100mm) representing pain intensity, where 0 represented no pain and 100 indicated unbearable pain. Participants are instructed to indicate a point on the scale corresponding to the pain intensity. The distance from the left end to the selected point is measured to calculate the pain score in millimeters.

  Baseline

• Visual analogue scale (VAS: 0-100mm)

  A visual analogue scale (VAS: 0-100mm) representing pain intensity, where 0 represented no pain and 100 indicated unbearable pain. Participants are instructed to indicate a point on the scale corresponding to the pain intensity. The distance from the left end to the selected point is measured to calculate the pain score in millimeters.

  Follow up at 3 months (end of intervention)

Secondary Outcomes (6)

• Short Form (36) Health Surve (SF-36)

  Baseline, follow up at 3 months after end of intervention

• Short Form (36) Health Surve (SF-36)

  Follow up at 3 months after end of intervention

• Disability of the Arm, Shoulder and Hand (DASH)

  Baseline, follow up at 3 months after end of intervention

• Disability of the Arm, Shoulder and Hand (DASH)

  Follow up at 3 months after end of intervention

• Heart rate variability (HRV) analysis

  Baseline, follow up at 3 months after end of intervention

Study Arms (2)

SGI irradiation

EXPERIMENTAL

Experimental group with active Linearly Polarized Near-Infrared light irradiation to stellate ganglion.

Other: Linearly Polarized Near-Infrared light Irradiation

Shame irradiation

SHAM COMPARATOR

Control group with shame Linearly Polarized Near-Infrared light irradiation to stellate ganglion.

Other: Linearly Polarized Near-Infrared light Irradiation

Interventions

Linearly Polarized Near-Infrared light Irradiation OTHER

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.

Also known as: Phototherapy

SGI irradiation; Shame irradiation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who age from 20 to 80 years and have a diagnosis of neuropathetic pain will be recruited from the chronic pain center at our hospital.

You may not qualify if:

• Patients who meted the following criteria are excluded:
• Diagnosis of glioblastoma,
• History of heart disease, serious arrhythmia or pacemaker user,
• Simmond disease or postpartum hypopituitarism,
• Habitual smoking or consumption of stimulant beverages such as tea, coffee, or alcohol, and
• Any other condition that is unsuitable for phototherapy by a doctor's evaluation.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

New Taipei City, 23561, Taiwan

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: July 24, 2017
• Study Start: October 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2024
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)