Adjuvant Acupuncture for Severe Head Injury
- Conditions
- Head Injury
- Interventions
- Other: acupunctureOther: controlOther: 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
- subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less)
- with informed consent
- 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
Group Intervention Description acupuncture acupuncture acupuncture on GV26 and 12 Well points control group control laser acupuncture without laser output in control group. laser acupuncture laser acupuncture laser acupuncture on GV26 and 12 Well points
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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