Adjuvant Acupuncture for Severe Head Injury

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head Injury

Intervention / Treatment
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* Other: acupuncture
* Other: laser acupuncture
* Other: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>acupuncture on GV26 and 12 Well points | Other: acupuncture<br>* acupuncture on GV26 and 12 Well points<br>|
| Experimental: laser acupuncture<br>laser acupuncture on GV26 and 12 Well points | Other: laser acupuncture<br>* laser acupuncture on GV26 and 12 Well points<br>|
| Sham Comparator: control group<br>laser acupuncture without laser output in control group. | Other: control<br>* sham laser acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Coma Scale (GCS) | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Power (MP) | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture; laser acupuncture; traumatic brain injury