Acupuncture for Severe Head Injury

This study is currently recruiting participants.
Verified June 2012 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01773291
First received: January 11, 2013
Last updated: January 18, 2013
Last verified: June 2012
  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 for 6 weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is observed.


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: 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 and muscle power [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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 determine 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 for 6 weeks and the change of subjects' GCS and muscle power is observed.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773291

Contacts
Contact: Sally Hsueh (03) 3196200 ext 3703 sally6869@cgmh.org.tw
Contact: Wen-Long Hu, MS (07) 7317123 ext 2329 oolonghu@gmail.com

Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: Wen-Long Hu, MS    +886-7-7317123 ext 2329    oolonghu@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Wen-Long Hu, MS Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01773291     History of Changes
Other Study ID Numbers: CMRPG8B1211, 102-0071C
Study First Received: January 11, 2013
Last Updated: January 18, 2013
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
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014