- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06785688
Energy Protector Aids for Improving the Lower Back Pain, Sports and Autonomic Nerve
January 14, 2025 updated by: Pei-Hung Liao, National Taipei University of Nursing and Health Sciences
The Effectiveness of Use an Energy Protector Aids for Improving the Lower Back Pain, Sports and Autonomic Nerve
The purpose of this study is to explore the impact of Protective gear irradiated by infrared rays intervention on back pain, motor protection and autonomic nerves.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
Before and after the experimental control study design, each case, using the Chinese version of the simple pain scale and autonomic nerve measurement and exercise protection knowledge as a research tool, before and after the test (3 months after using the protective gear), collected Lower back pain level: changes in pain intensity and pain effects, and changes in autonomic and motor protection knowledge before and after testing.
The research data uses SPSS for Windows 25.0 software package English version for data processing and analysis.
The main statistics are Independent t test, Pair samples t test, Chi-square test and Odds ratio etc.
It is expected that in the future, patients will be able to provide a safe and effective pain care and improve the quality of life, thereby reducing the recurrence rate of back pain and reducing the social cost of medical treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan
- National Taipei University of Nursing and Health Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
inclusion criteria were: (1) individuals aged 20 to 80 with self-determined lower back pain who scored 3 points or higher on a brief pain scale; and (2) individuals accustomed to using far infrared devices for lower back pain.
excluded criteria were: Unconscious individuals were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1 experiment(50)
Far-infrared Devices on Lower Back Pain keep 4times/week
|
irradiated by infrared rays back brace
|
|
Active Comparator: 1 control (50)
routine Nursing education after out patient department 60 people
|
irradiated by infrared rays back brace
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
back pain sereve & impact
Time Frame: contineous use back brace for 3 months
|
check back pain degree
|
contineous use back brace for 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2023
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
January 31, 2025
Study Registration Dates
First Submitted
May 22, 2023
First Submitted That Met QC Criteria
January 14, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 14, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 777(109-16)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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