- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03228160
Light Irradiation and Outcome for Neuropathic Pain
Effects of Linearly Polarized Near-Infrared Irradiation in Patients With Sympathetically Maintained Neuropathic Pain Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sympathetically maintained pain (SMP) is defined as an aspect of pain which is maintained or mediated by sympathetic efferent activity including the action of circulating catecholamine and is often linked to the complex regional pain syndrome (CRPS). SMP has been categorized as a subset of neuropathic pain mediated by the underlying mechanism of peripheral sensitization referring to noradrenergic sensitization of peripheral afferent nociceptive fibers and a pathologically sympathetic-sensory coupling interaction between the efferent sympathetic and the afferent system. Besides, SMP is associated with vasomotor and sudomotor dysfunction through either peripheral integerized by an adrenoreceptor stimulated or central organized by sensitization. Therefore, modulation of sympathetic activity either by means of pharmacological analgesics or local sympathetic ganglion blockade may influence the pain course in patients with chronic pain and hyperalgesia that were suspected to be sympathetically maintained.
The pain associated with sympathetic activity can be relieved by blockage of efferent sympathetic nerves to the affected area. Stellate ganglion block (SGB), a local anesthetic blockade of sympathetic ganglia, has been advocated as an early intervention to achieve sympatholysis and its strong evidence had been identified. However, a success of SGB depends on the skilled invasive technique in application and several potential complications may be elucidated. Alternatively, the light irradiation near the stellate ganglion region (SGI) using either low-reactive level laser or linear-polarized near-infrared light irradiation had been used as a noninvasive method for local anesthetic sympathetic blockade. Furthermore, SGI can be safely and conveniently performed in clinical practice even when an anesthetic physician is not available, had been well tolerated by patients, and no thermal injury or side effects were reported by literatures.
SGI had been identified to offer similar effects of SGB for patients with neuropathic pain, including improving blood flow by dilating vessels and reducing pain by directly blocking afferent nociceptive signal traveling via sympathetic pathways. The irradiation effect on heart rate variability (HRV), which is an objectively non-invasive marker of the autonomic nervous system, had not yet been well established. If the pathogenesis of SMP is closely referred to some abnormality in the function of autonomic nerve system (ANS), it is more necessary to measure autonomic activity for validation rather than pain status, local temperature or peripheral blood flow. Whether the relieved pain level after SGI is associated to HRV changes remains unclear. Identifying the relationship between HRV and pain status following SGI allows the clinicians to set a prompt protocol of phototherapy using SGI, and to accurately follow the outcome of autonomic dysfunction in patients with SMP.
The purpose of this study was to demonstrate the sympatholytic and clinical effects of linear polarized near-infrared irradiation applied on stellate ganglion in patients with SMP.
An experimental design with two groups will be used and a double blind, prospective randomized control trial will be conducted at the chronic pain medicine center in the physical medicine and rehabilitation department. Potential patients will be recruited. The enrolled patients will be randomly assigned to the experimental group or the control group (CG) using a table of random numbers. Patients in the experimental group will receive a 6-week standard SGI treatment protocol (12 irradiation sessions), while those in the control group being undergo a sham irradiation during the same period. Both the investigators and the patients will be blinded to the group assignments. All outcome measures will be collected by a trained research assistant at the baseline admission prior to SGI therapy, before and after SGI at each irradiation session, and at the follow up admission immediately after the end of 6-week treatment period.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan, 23561
- Shuang Ho Hospital, Taipei Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SGI irradiation
Experimental group with active Linearly Polarized Near-Infrared light irradiation to stellate ganglion.
|
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.
Other Names:
|
Sham Comparator: Shame irradiation
Control group with shame Linearly Polarized Near-Infrared light irradiation to stellate ganglion.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale (VAS: 0-100mm)
Time Frame: Baseline
|
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)
Time Frame: Follow up at 3 months (end of intervention)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form (36) Health Surve (SF-36)
Time Frame: Baseline, follow up at 3 months after end of intervention
|
Assessment of quality of life
|
Baseline, follow up at 3 months after end of intervention
|
Short Form (36) Health Surve (SF-36)
Time Frame: Follow up at 3 months after end of intervention
|
Assessment of quality of life
|
Follow up at 3 months after end of intervention
|
Disability of the Arm, Shoulder and Hand (DASH)
Time Frame: Baseline, follow up at 3 months after end of intervention
|
Function evaluation of upper quarter
|
Baseline, follow up at 3 months after end of intervention
|
Disability of the Arm, Shoulder and Hand (DASH)
Time Frame: Follow up at 3 months after end of intervention
|
Function evaluation of upper quarter
|
Follow up at 3 months after end of intervention
|
Heart rate variability (HRV) analysis
Time Frame: Baseline, follow up at 3 months after end of intervention
|
HRV was measured using an ANSWatch wrist monitor (Taiwan Scientific Co., Taipei, Taiwan).
|
Baseline, follow up at 3 months after end of intervention
|
Heart rate variability (HRV) analysis
Time Frame: Follow up at 3 months after end of intervention
|
HRV was measured using an ANSWatch wrist monitor (Taiwan Scientific Co., Taipei, Taiwan).
|
Follow up at 3 months after end of intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201511030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complex Regional Pain Syndrome
-
University of Sao PauloUniversity of Sao Paulo General HospitalUnknownComplex Regional Pain Syndrome I of Upper LimbBrazil
-
Ruhr University of BochumUnknownComplex Regional Pain Syndrome Type I of the Upper LimbGermany
-
University of ZurichBalgrist University HospitalRecruitingComplex Regional Pain Syndrome I (CRPS I) | Complex Regional Pain Syndromes | Osteoarthritis Hand | Complex Regional Pain Syndrome Type II | Complex Regional Pain Syndrome Type I of the Upper Limb | Complex Regional Pain Syndrome I of Upper Limb | Complex Regional Pain Syndrome II of Upper Limb | Peripheral Nerve Injury Upper Limb and other conditionsSwitzerland
-
Hospital for Special Surgery, New YorkNot yet recruitingChronic Pain | Complex Regional Pain Syndrome | Causalgia | Complex Regional Pain Syndrome Type I | Complex Regional Pain Syndrome Type IIUnited States
-
Grünenthal GmbHTerminatedComplex Regional Pain Syndrome (CRPS)United States, Australia, France, Germany, Korea, Republic of, New Zealand, Spain
-
University of GroningenWithdrawnComplex Regional Pain Syndrome Type I of the Upper LimbNetherlands
-
The Cleveland ClinicMurdoch UniversityTerminatedComplex Regional Pain Syndrome (CRPS)United States
-
Stanford UniversityCompletedComplex Regional Pain Syndrome (CRPS)United States
-
Stanford UniversityCompleted
-
Grünenthal GmbHCompletedComplex Regional Pain Syndrome, Type IUnited States, Germany, United Kingdom
Clinical Trials on Linearly Polarized Near-Infrared light Irradiation
-
China Medical University HospitalNot yet recruiting
-
University of MiamiOffice of Naval Research (ONR)Completed
-
University College, LondonMoorfields Eye Hospital NHS Foundation TrustRecruiting
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Cerehealth Corp.Colorado Neurological Institute; Tug McGraw FoundationCompletedTBI (Traumatic Brain Injury)
-
Samueli Institute for Information BiologyWilliam Beaumont Army Medical CenterTerminated
-
Universidad de ValparaisoComisión Nacional de Investigación Científica y TecnológicaUnknownOpen Angle GlaucomaChile
-
Ohio State UniversityCompletedNeoplasms | Bone Diseases | Musculoskeletal Disease | Skull Base Neoplasms | Skull Neoplasms | Bone NeoplasmUnited States
-
Uludag UniversityCompletedKnowledge, Attitudes, Practice | ImageTurkey
-
Washington University School of MedicineNational Institute for Biomedical Imaging and Bioengineering (NIBIB)CompletedBreast Cancer | Breast Tumors | Cancer of Breast | Malignant Neoplasm of Breast | Cancer of the BreastUnited States