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Adjuvant Acupuncture for Severe Head Injury

Primary Purpose

Head Injury

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
laser acupuncture
control
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Injury focused on measuring Acupuncture; laser acupuncture; traumatic brain injury

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

acupuncture

laser acupuncture

control group

Arm Description

acupuncture on GV26 and 12 Well points

laser acupuncture on GV26 and 12 Well points

laser acupuncture without laser output in control group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 11, 2013
Last Updated
December 22, 2015
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01773291
Brief Title
Adjuvant Acupuncture for Severe Head Injury
Official Title
Adjuvant Acupuncture Therapy in Patients With Severe Head Injury: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury
Keywords
Acupuncture; laser acupuncture; traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm Description
acupuncture on GV26 and 12 Well points
Arm Title
laser acupuncture
Arm Type
Experimental
Arm Description
laser acupuncture on GV26 and 12 Well points
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
laser acupuncture without laser output in control group.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
acupuncture on GV26 and 12 Well points
Intervention Type
Other
Intervention Name(s)
laser acupuncture
Intervention Description
laser acupuncture on GV26 and 12 Well points
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
sham laser acupuncture
Primary Outcome Measure Information:
Title
Glasgow Coma Scale (GCS)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Muscle Power (MP)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Long Hu, MS
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21209492
Citation
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.
Results Reference
background
PubMed Identifier
11222792
Citation
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.
Results Reference
background
PubMed Identifier
16720934
Citation
Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8.
Results Reference
result
Links:
URL
http://www.intechopen.com/books/acupuncture-clinical-practice-particular-techniques-and-special-issues/acupuncture-for-disorders-of-consciousness-a-case-series-and-review
Description
Acupuncture for Disorders of Consciousness - A Case Series and Review
URL
http://dx.doi.org/10.15344/2394-4978/2015/121
Description
Efficacy of Stimulation at the Jing-Well Points of Meridians

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Adjuvant Acupuncture for Severe Head Injury

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