Adjuvant Acupuncture for Severe Head Injury

NCT ID: NCT01773291

Last Updated: 2016-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-07-31

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.

Conditions

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Head Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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acupuncture

acupuncture on GV26 and 12 Well points

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

acupuncture on GV26 and 12 Well points

laser acupuncture

laser acupuncture on GV26 and 12 Well points

Group Type EXPERIMENTAL

laser acupuncture

Intervention Type OTHER

laser acupuncture on GV26 and 12 Well points

control group

laser acupuncture without laser output in control group.

Group Type SHAM_COMPARATOR

control

Intervention Type OTHER

sham laser acupuncture

Interventions

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acupuncture

acupuncture on GV26 and 12 Well points

Intervention Type OTHER

laser acupuncture

laser acupuncture on GV26 and 12 Well points

Intervention Type OTHER

control

sham laser acupuncture

Intervention Type OTHER

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen-Long Hu, MS

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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DeFina PA, Fellus J, Thompson JW, Eller M, Moser RS, Frisina PG, Schatz P, Deluca J, Zigarelli-McNish M, Prestigiacomo CJ. Improving outcomes of severe disorders of consciousness. Restor Neurol Neurosci. 2010;28(6):769-80. doi: 10.3233/RNN-2010-0548.

Reference Type BACKGROUND
PMID: 21209492 (View on PubMed)

Jennett B, Adams JH, Murray LS, Graham DI. Neuropathology in vegetative and severely disabled patients after head injury. Neurology. 2001 Feb 27;56(4):486-90. doi: 10.1212/wnl.56.4.486.

Reference Type BACKGROUND
PMID: 11222792 (View on PubMed)

Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8.

Reference Type RESULT
PMID: 16720934 (View on PubMed)

Related Links

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Other Identifiers

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103-5150C

Identifier Type: OTHER

Identifier Source: secondary_id

CMRPG8B1211

Identifier Type: -

Identifier Source: org_study_id

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