Evaluation of Laser Acupuncture on Health Promotion of Sub-health People

NCT ID: NCT04325945

Last Updated: 2020-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2021-12-31

Brief Summary

Background: Suboptimal health status (SHS) is a dynamic state wherein people have not been diagnosed with a disease but tend to develop diseases. People with SHS often experience fatigue and other nonspecific symptoms. Early TCM-based interventions in people with SHS can prevent them from developing chronic diseases, thereby reducing the burden on health insurance systems. No study has explored the effects of laser acupuncture (LA) on people with SHS.

Material and Methods: Thirty SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled and assigned into a experiment group and a control group randomly in the first year protocol. One week before the start of the experiment, we will use questionnaires and mobile cloud-based devices to assess the physical status, such as blood pressure, body mass index, waist girth, hips girth, blood oxygen saturation, physical activity, pulse signal, autonomic nervous function, and sleep patterns. The subjects in the treatment groups received LA and those in control group received sham LA for 15 minutes per session twice a week for 8 weeks (16 sessions totally). All questionnaires, physical status and objective sleep parameters will be assessed in treatment group and control group after the 16th session. In the second year protocol, seventy SHS subjects will be enrolled and same procedure will be performed as the first year protocol.

Detailed Description

Background: Suboptimal health status (SHS) is a dynamic state. The term refers to an existing condition of ill health that could lead to a pathological condition but could also be eliminated, enabling the individual in question to return to a state of good health.

Traditional Chinese medicine (TCM) emphasizes the importance of health care and the idea that preventive treatment for diseases is superior to curative treatment. Therefore, TCM intervention will be eliminated SHS becoming to a chronic disease. According to previous studies, people with SHS without sports habits have 8 times risk of developing hypertension. In addition, people with SHS have more rates of sleep disorders, which are associated with obstructive sleep apnea due to decreased oxygen maturation during sleep, than healthy subjects.

A cloud TCM health-care model, which is combined with constitution patterns in TCM and physiological parameters, applied to Taiwanese with SHS. Taiwanese with SHS, no matter yang deficiency, Ying deficiency or Phlegm-stasis patterns, have decreased cardiac parasympathetic activity and high frequency change in pulse power spectrum analysis at right Chi. This phenomenon implied that people with SHS reduced convergence of the ministerial fire in the gate of life and then developed a disharmonic status between "Heart" and "Kidney" in TCM. This theory can explain why SHS has sleep disorders and prehypertension.

Laser acupuncture (LA) has been used in preventive diseases and many effects. Modern researches showed LA improved insomnia, circulation, analgesia and metabolism. However, it is still lacking evidences of objective parameters of sleep and there are no studies about TCM patterns change in SHS by LA.

In this study, the effects of 8 weeks' LA intervention on people with SHS presented with pre-hypertension and/or sleep disorders by a cloud health-care system combined with TCM patterns and physiological parameters will be investigated by 2-years protocols. The result will be helpful to establish the role of LA for preventive medicine in Taiwan.

Hypothesis: Regular LA intervention can improve sleep quality and regulate blood pressure and autonomic nervous function of sub-healthy people. Moreover, combining the cloud-based TCM body constitution and physical healthcare system can help sub-healthy people manage their own health better.

Material and Methods: Thirty SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled and will be assigned into a experiment group and a control group randomly in the first year protocol. One week before the start of the experiment, we will use questionnaires and mobile cloud-based devices to assess the physical status, such as blood pressure, body mass index, waist girth, hips girth, blood oxygen saturation, physical activity, pulse signal, autonomic nervous function, and sleep patterns. The subjects in the treatment groups received LA and those in control group received sham LA for 15 minutes per session twice a week for 8 weeks (16 sessions totally). All questionnaires will assessed in treatment group and control group before the first session and after the 16th session. In addition, we using mobile cloud-based devices to assess the physical status, such as blood pressure, blood oxygen saturation, physical activity, pulse signal, tongue examination, and autonomic nervous function before and after each sessions. Furthermore, sleep patterns will assessed for at least 2 days.

In the second year protocol, seventy SHS subjects with pre-hypertension or/and insomnia or/and obesity will be enrolled. and assigned into a experiment group and a control group randomly. The evaluation methods are the same as the first year protocol. Besides, we will build up the cloudy system to present body constitution scores and objective parameters. The auto-feedback function will be established in the second year protocol.

Conditions

Suboptimal Health Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Laser acupuncture

808nm low level laser therapy

Group Type: EXPERIMENTAL

Low level laser therapy

Intervention Type: DEVICE

808nm low level laser therapy on acupuncture points

Sham laser acupuncture

no low level laser output but same device

Group Type: SHAM_COMPARATOR

Low level laser therapy

Intervention Type: DEVICE

808nm low level laser therapy on acupuncture points

Interventions

Low level laser therapy

808nm low level laser therapy on acupuncture points

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Measure blood pressure at rest 120-139 / 80-89 mmHg more than 3 times a week.

PSQI score greater than 5.

Body mass index (BMI) :24~30 Kg/m2

Exclusion Criteria

• Patients diagnosed with chronic diseases, such as hypertension, diabetes, chronic hepatitis, chronic kidney disease, chronic hyperlipidemia, coronary heart disease and other diseases that fall into the scope of chronic diseases of universal health insurance.

Diagnosis of mental illness.

Cancer patient

Pregnancy

People with significant inflammation at the time of participation.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

vghtpe user

Director, Center for Traditional Medicine, Principal Investigator, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yen-Ying Kung, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Traditional Medicine,Taipei Veterans General Hospital

Locations

Center for Traditional Medicine, Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yen-Ying Kung, MD

Role: CONTACT

yykung@vghtpe.gov.tw

886-2-28757453 ext. 215

Facility Contacts

Yenying Kung, MD

Role: primary

yykung@vghtpe.gov.tw

886-2-28730502

Other Identifiers

2020-01-026CCF

Identifier Type: -

Identifier Source: org_study_id