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Adjuvant Acupuncture for Severe Head Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773291
First Posted: January 23, 2013
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
  Purpose
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.

Condition Intervention
Head Injury Other: acupuncture Other: laser acupuncture Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjuvant Acupuncture Therapy in Patients With Severe Head Injury: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Glasgow Coma Scale (GCS) [ Time Frame: 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:
  • Muscle Power (MP) [ Time Frame: 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.



Enrollment: 24
Study Start Date: January 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture
acupuncture on GV26 and 12 Well points
Other: acupuncture
acupuncture on GV26 and 12 Well points
Experimental: laser acupuncture
laser acupuncture on GV26 and 12 Well points
Other: laser acupuncture
laser acupuncture on GV26 and 12 Well points
Sham Comparator: control group
laser acupuncture without laser output in control group.
Other: control
sham laser acupuncture

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773291


Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Wen-Long Hu, MS Chang Gung Memorial Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01773291     History of Changes
Other Study ID Numbers: CMRPG8B1211
103-5150C ( Other Identifier: Chang Gung Medical Foundation Institutional Review Board )
First Submitted: January 11, 2013
First Posted: January 23, 2013
Results First Submitted: August 25, 2015
Results First Posted: November 2, 2015
Last Update Posted: January 28, 2016
Last Verified: July 2015

Keywords provided by Chang Gung Memorial Hospital:
Acupuncture; laser acupuncture; traumatic brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases