Adjuvant Acupuncture for Severe Head Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01773291
First received: January 11, 2013
Last updated: December 22, 2015
Last verified: July 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 11, 2013
Results First Received: August 25, 2015
Last Updated: December 22, 2015
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 01, 2016