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Trial registered on ANZCTR


Registration number
ACTRN12613000964718
Ethics application status
Approved
Date submitted
23/08/2013
Date registered
29/08/2013
Date last updated
29/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a Far-Infrared Ray Patch on Neck Pain Relief
Scientific title
Effects of a Far-Infrared Ray Patch on Neck Pain Relief
Secondary ID [1] 283075 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neck pain 289913 0
Condition category
Condition code
Musculoskeletal 290280 290280 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The far-infrared ray carbon fiber patch obtained from Linkwin Technology Co., LTD. The patch has a size of 16.5cm x 8.5cm. We put the patch on the participants' neck area for 30 minutes once for the experiment.
Intervention code [1] 287791 0
Treatment: Devices
Comparator / control treatment
The control group used a neck patch (ThermaCare, Pfizer Inc.) without far-infrared ray imported. ThermaCare neck patch has a size of 19cm x 7.5cm. We put it on the participants' neck area for 30 minutes once.
Control group
Active

Outcomes
Primary outcome [1] 290311 0
Neck pain relief is evaluated by Visual Analog Scale. We found that the patch without FIR reduce 45% in pain and the patch with FIR reduce 52% in pain.
Timepoint [1] 290311 0
After 30 minutes.
Secondary outcome [1] 304291 0
Neck area temperature of the control group and experimental group were 34.9 +/- 0.2 degrees Celsius and 35.1 +/- 0.1 degrees Celsius assessed using a Fluke Ti25 thermal imager.
Timepoint [1] 304291 0
After 30 minutes
Secondary outcome [2] 304328 0
The blood flow of the control group increased significantly to 152.5 +/- 12.1 PU detected by MoorLDI2-IR Laser Doppler Imager. And the experimental group increased significantly to 167.2 +/- 15.1 PU detected by MoorLDI2-IR Laser Doppler Imager.
Timepoint [2] 304328 0
After 30 minutes
Secondary outcome [3] 304329 0
The heart rate variability of the control group increased significantly to 79.5 +/- 23.8 ms and the heart rate of the experimental group increased to 79.8 +/- 24.9 ms. They were detected by ANSWatch TS-0411 (Taiwan Scientific Corp., Taiwan, Republic of China).
Timepoint [3] 304329 0
After 30 minutes

Eligibility
Key inclusion criteria
Neck pain for at least one month.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women and the neck wound such as surgical trauma.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5339 0
Taiwan, Province Of China
State/province [1] 5339 0

Funding & Sponsors
Funding source category [1] 287837 0
University
Name [1] 287837 0
Hungkuang University
Address [1] 287837 0
No. 1018, Sec. 6, Taiwan Boulevard, Shalu District, Taichung, 44302, Taiwan, R.O.C.
Country [1] 287837 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Yung-Sheng Lin
Address
Department of Applied Cosmetology and Master Program of Cosmetic Science, Hungkuang University, No. 1018, Sec. 6, Taiwan Boulevard, Shalu District, Taichung, 44302, Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 286562 0
None
Name [1] 286562 0
none
Address [1] 286562 0
none
Country [1] 286562 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study verified the FIR non-thermal neck pain relief effect. Compared to the control group without FIR, the FIR patch demonstrated brilliant improvements in skin warming capability, blood flow, and heart rate variability. This investigation revealed that the FIR patch has the capacity to reduce neck pain. This innovative FIR patch can provide complementary therapy to help solve neck pain disorders. This work was just a short-term experiment to show the advantages of FIR. A long term study to evaluate the non-thermal effect on neck disorder relief should be carried out.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42378 0
Prof Yung-Sheng Lin
Address 42378 0
Department of Applied Cosmetology and Master Program of Cosmetic Science, Hungkuang University, No. 1018, Sec. 6, Taiwan Boulevard, Shalu District, Taichung, 44302, Taiwan, R.O.C.
Country 42378 0
Taiwan, Province Of China
Phone 42378 0
+886-4-26318652 ext. 3684
Fax 42378 0
Email 42378 0
linys@sunrise.hk.edu.tw
Contact person for public queries
Name 42379 0
Prof Yung-Sheng Lin
Address 42379 0
Department of Applied Cosmetology and Master Program of Cosmetic Science, Hungkuang University, No. 1018, Sec. 6, Taiwan Boulevard, Shalu District, Taichung, 44302, Taiwan, R.O.C.
Country 42379 0
Taiwan, Province Of China
Phone 42379 0
+886-4-26318652 ext. 3684
Fax 42379 0
Email 42379 0
linys@sunrise.hk.edu.tw
Contact person for scientific queries
Name 42380 0
Prof Yung-Sheng Lin
Address 42380 0
Department of Applied Cosmetology and Master Program of Cosmetic Science, Hungkuang University, No. 1018, Sec. 6, Taiwan Boulevard, Shalu District, Taichung, 44302, Taiwan, R.O.C.
Country 42380 0
Taiwan, Province Of China
Phone 42380 0
+886-4-26318652 ext. 3684
Fax 42380 0
Email 42380 0
linys@sunrise.hk.edu.tw

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary