Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients

NCT04930146 | Unknown

• 1 other identifier: 202100683A3
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic brain injury (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the Jing-points on TBI patients still unknown. In our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of Jing-point puncture to improve consciousness and neurological function in patients with TBI. In addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of TBI patients.

Conditions

Traumatic Brain Injury (TBI)

Keywords

Traumatic brain injury, TBI; Bloodletting; acupuncture

Outcome Measures

Primary Outcomes (5)

• GCS(Glasgow Coma Scale)

  To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death.

  4 weeks

• Barthel index

  To assess the activities of daily life.

  4 weeks

• Muscle power

  To assess the recovery of muscle power.

  4 weeks

• mGOS(Modified Glasgow Outcome Score)

  To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome.

  4 weeks

• RTS (Revised Trauma Score)

  To assess the physiologic condition of patients. The Revised Trauma Score is made up of a three categories: Glasgow Coma Scale, systolic blood pressure, and respiratory rate. The score range is 0-12. A lower score indicates a higher severity of injury.

  4 weeks

Secondary Outcomes (1)

• Meridian energy assessment

  4 weeks

Study Arms (4)

Intervention group (Severe)

EXPERIMENTAL

A patient's Glasgow Coma Score (GCS) between 5-8 1. Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. 2. Evaluating the meridian energy by M.E.A.D

Other: acupuncture and bloodletting

Control group (Severe)

NO INTERVENTION

A patient's Glasgow Coma Score (GCS) between 5-8 1. Conventional treatment. 2. Evaluating the meridian energy by M.E.A.D

Intervention group (Moderate)

EXPERIMENTAL

A patient's Glasgow Coma Score (GCS) between 9-13 1. Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. 2. Evaluating the meridian energy by M.E.A.D

Other: acupuncture and bloodletting

Control group (moderate)

NO INTERVENTION

A patient's Glasgow Coma Score (GCS) between 9-13 1. Conventional treatment. 2. Evaluating the meridian energy by M.E.A.D

Interventions

acupuncture and bloodletting OTHER

bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments.

Intervention group (Moderate); Intervention group (Severe)

Eligibility Criteria

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

You may qualify if:

• Patient with moderate to severe head injury are admitted to the ICU (Intensive Care Unit). patient with stable vital sign and the GCS (Glasgow coma volume) between 5-13 will be included.
• Patient with normal consciousness and no cognitive or motor function disease before brain injury.
• Patient aged between 20 to 80 years old and is willing to sign the consent (the agent can sign on behalf of patient).

You may not qualify if:

• Patients who are vital sign unstable and with severe complication.
• Patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on.
• Pregnant patients.
• Any other conditions deemed unsuitable by the physician in charge.
• Patients (agent of the patient) who did not sign the consent.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Acupuncture Therapy; Bloodletting

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Phlebotomy; Punctures

Study Officials

• wei Ling Chou

  Chang Gung Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei Ling Chou

CONTACT

+886 975360906; wenni1207@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 18, 2021
• Study Start: June 8, 2021
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)