Adjuvant Acupuncture for Severe Head Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Head Injury
• Intervention / Treatment: Other: acupuncture; Other: laser acupuncture; Other: control

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Wen-Long Hu, MS, Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1212/wnl.56.4.486.
• Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (Estimate): January 23, 2013

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Acupuncture; laser acupuncture; traumatic brain injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: CMRPG8B1211; 103-5150C (Other Identifier: Chang Gung Medical Foundation Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No