Trial record 5 of 368 for:    Open Studies | "Craniocerebral Trauma"

Acupuncture for Severe Head Injury

This study is currently recruiting participants. (see Contacts and Locations)
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
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

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
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014