Skip to main content
OpenTrials
Completed

NCT Number: NCT01773291

Adjuvant Acupuncture for Severe Head Injury

The purpose of this study is to determine the therapeutic effect of acupuncture on severe head injury under conventional treatment. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

About this study

Objective: To investigate the therapeutic effect of acupuncture on severe head injury under conventional treatment.

Methods: 90 subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less) are randomly divided into acupuncture, laser acupuncture and control group. We use restoring consciousness acupuncture (GV26 and 12 Well points) to treat the subjects 3 sessions per week under conventional treatment at Department of Neurosurgery. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' GCS and muscle power is measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less)
  • with informed consent

Exclusion criteria

  • dilated pupils without light reflex
  • serious complications during therapeutic course
  • interruption of therapeutic course
  • unfavored condition assessed by physician in charge
  • without informed consent

Treatment and study plan

Acupuncture

Other

acupuncture on GV26 and 12 Well points

Laser Acupuncture

Other

laser acupuncture on GV26 and 12 Well points

Control

Other

sham laser acupuncture

Primary outcomes

  1. Glasgow Coma Scale (GCS)

    Time frame: 6 weeks

    Eye response (E)

    There are four grades starting with the most severe:

    • No eye opening
    • Eye opening in response to pain stimulus.
    • Eye opening to speech.
    • Eyes opening spontaneously Verbal response (V)

    There are five grades starting with the most severe:

    • No verbal response
    • Incomprehensible sounds.
    • Inappropriate words.
    • Confused.
    • Oriented. Motor response (M)

    There are six grades:

    • No motor response
    • Decerebrate posturing accentuated by pain
    • Decorticate posturing accentuated by pain
    • Withdrawal from pain
    • Localizes to pain
    • Obeys commands

    The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome.

Secondary outcomes

  1. Muscle Power (MP)

    Time frame: 6 weeks

    Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement

    • Flicker of movement only
    • Movement possible when assisted by gravity or gravity is eliminated
    • Movement possible against gravity but without imposed resistance
    • Weak movement possible against gravity
    • Normal movement against gravity and against imposed resistance

    The 4 muscle groups were assessed on the 0 to 5 scale and scores were summed before and after treatment during hospitalization. The total score ranges from 0-20, with higher score indicating better outcome.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Adjuvant Acupuncture Therapy in Patients With Severe Head Injury: a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2013
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.