MedPath

Adjuvant Acupuncture for Severe Head Injury

Not Applicable
Completed
Conditions
Head Injury
Interventions
Other: acupuncture
Other: control
Other: laser acupuncture
Registration Number
NCT01773291
Lead Sponsor
Chang Gung Memorial Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
acupunctureacupunctureacupuncture on GV26 and 12 Well points
control groupcontrollaser acupuncture without laser output in control group.
laser acupuncturelaser acupuncturelaser acupuncture on GV26 and 12 Well points
Primary Outcome Measures
NameTimeMethod
Glasgow Coma Scale (GCS)6 weeks

Eye response (E)

There are four grades starting with the most severe:

1. No eye opening

2. Eye opening in response to pain stimulus.

3. Eye opening to speech.

4. Eyes opening spontaneously Verbal response (V)

There are five grades starting with the most severe:

1. No verbal response

2. Incomprehensible sounds.

3. Inappropriate words.

4. Confused.

5. Oriented. Motor response (M)

There are six grades:

1. No motor response

2. Decerebrate posturing accentuated by pain

3. Decorticate posturing accentuated by pain

4. Withdrawal from pain

5. Localizes to pain

6. Obeys commands

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

Secondary Outcome Measures
NameTimeMethod
Muscle Power (MP)6 weeks

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

1. Flicker of movement only

2. Movement possible when assisted by gravity or gravity is eliminated

3. Movement possible against gravity but without imposed resistance

4. Weak movement possible against gravity

5. 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.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital

🇨🇳

Kaohsiung, Taiwan

© Copyright 2025. All Rights Reserved by MedPath