Acupuncture for Severe Head Injury
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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 |
- 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 |
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| Contact: Sally Hsueh | (03) 3196200 ext 3703 | sally6869@cgmh.org.tw |
| Contact: Wen-Long Hu, MS | (07) 7317123 ext 2329 | oolonghu@gmail.com |
| Taiwan | |
| Kaohsiung Chang Gung Memorial Hospital | Recruiting |
| Kaohsiung, Taiwan, 833 | |
| Contact: Wen-Long Hu, MS +886-7-7317123 ext 2329 oolonghu@gmail.com | |
| 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 May 21, 2013