Adjuvant Acupuncture for Severe Head Injury

Head Injury Clinical Trial

Official title:

Adjuvant Acupuncture Therapy in Patients With Severe Head Injury: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773291
• Other study ID #: CMRPG8B1211
• Secondary ID: 103-5150C
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: December 22, 2015
• Start date: January 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury

Intervention

Other:
• acupuncture
acupuncture on GV26 and 12 Well points
• laser acupuncture
laser acupuncture on GV26 and 12 Well points
• control
sham laser acupuncture

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8. — View Citation

DeFina PA, Fellus J, Thompson JW, Eller M, Moser RS, Frisina PG, Schatz P, Deluca J, Zigarelli-McNish M, Prestigiacomo CJ. Improving outcomes of severe disorders of consciousness. Restor Neurol Neurosci. 2010;28(6):769-80. doi: 10.3233/RNN-2010-0548. — View Citation

Jennett B, Adams JH, Murray LS, Graham DI. Neuropathology in vegetative and severely disabled patients after head injury. Neurology. 2001 Feb 27;56(4):486-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Coma Scale (GCS)	Eye response (E); There are four grades starting with the most severe: No eye opening; Eye opening in response to pain stimulus.; Eye opening to speech.; Eyes opening spontaneously Verbal response (V); There are five grades starting with the most severe: No verbal response; Incomprehensible sounds.; Inappropriate words.; Confused.; Oriented. Motor response (M); There are six grades: No motor response; Decerebrate posturing accentuated by pain; Decorticate posturing accentuated by pain; Withdrawal from pain; Localizes to pain; Obeys commands; The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome.	6 weeks	No
Secondary	Muscle Power (MP)	Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement; Flicker of movement only; Movement possible when assisted by gravity or gravity is eliminated; Movement possible against gravity but without imposed resistance; Weak movement possible against gravity; 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.	6 weeks	No

External Links

•   Acupuncture for Disorders of Consciousness - A Case Series and Review
•   Efficacy of Stimulation at the Jing-Well Points of Meridians