Trial Outcomes & Findings for Adjuvant Acupuncture for Severe Head Injury (NCT NCT01773291)

Results Overview

Eye response (E) There are four grades starting with the most severe: 1. No eye opening 2. Eye opening in response to pain stimulus. 3. Eye opening to speech. 4. Eyes opening spontaneously Verbal response (V) There are five grades starting with the most severe: 1. No verbal response 2. Incomprehensible sounds. 3. Inappropriate words. 4. Confused. 5. Oriented. Motor response (M) There are six grades: 1. No motor response 2. Decerebrate posturing accentuated by pain 3. Decorticate posturing accentuated by pain 4. Withdrawal from pain 5. Localizes to pain 6. Obeys commands The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

6 weeks

Results posted on

2016-01-28

Participant Flow

Patients with severe traumatic brain injury (Glasgow Coma Scale, GCS ≤ 8) admitted to neurosurgical intensive care unit (NSICU) were enrolled and randomly divided into three groups sequentially.

Exclusion criteria: dilated pupils without light reflex, unstable vital signs, serious complication during therapeutic course, serious multiple injuries, withdrawal by subject, physician decision, without informed consent.

Participant milestones

Participant milestones
Measure	Acupuncture acupuncture on Shuigou (GV26) and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points	Laser Acupuncture laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points	Control Group laser acupuncture without laser output in control group. control: sham laser acupuncture on GV26 and 12 Well points
Overall Study STARTED	8	9	7
Overall Study COMPLETED	7	9	6
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Acupuncture acupuncture on Shuigou (GV26) and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points	Laser Acupuncture laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points	Control Group laser acupuncture without laser output in control group. control: sham laser acupuncture on GV26 and 12 Well points
Overall Study Protocol Violation	1	0	0
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Adjuvant Acupuncture for Severe Head Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupuncture n=7 Participants acupuncture on GV26 and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points	Laser Acupuncture n=9 Participants laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points	Control Group n=6 Participants laser acupuncture without laser output in control group. control: sham laser acupuncture	Total n=22 Participants Total of all reporting groups
Age, Continuous	40.29 years STANDARD_DEVIATION 17.14 • n=5 Participants	49.11 years STANDARD_DEVIATION 16.86 • n=7 Participants	47.17 years STANDARD_DEVIATION 21.47 • n=5 Participants	45.77 years STANDARD_DEVIATION 17.82 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment Taiwan	7 participants n=5 Participants	9 participants n=7 Participants	6 participants n=5 Participants	22 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The GCS was measured before and after treatment during hospitalization.

Eye response (E) There are four grades starting with the most severe: 1. No eye opening 2. Eye opening in response to pain stimulus. 3. Eye opening to speech. 4. Eyes opening spontaneously Verbal response (V) There are five grades starting with the most severe: 1. No verbal response 2. Incomprehensible sounds. 3. Inappropriate words. 4. Confused. 5. Oriented. Motor response (M) There are six grades: 1. No motor response 2. Decerebrate posturing accentuated by pain 3. Decorticate posturing accentuated by pain 4. Withdrawal from pain 5. Localizes to pain 6. Obeys commands The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome.

Outcome measures

Outcome measures
Measure	Acupuncture n=7 Participants acupuncture on GV26 and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points	Laser Acupuncture n=9 Participants laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points	Control Group n=6 Participants laser acupuncture without laser output in control group. control: sham laser acupuncture on GV26 and 12 Well points
Glasgow Coma Scale (GCS)	3.14 units on a scale Standard Deviation 1.46	3.11 units on a scale Standard Deviation 3.02	4.67 units on a scale Standard Deviation 2.73

SECONDARY outcome

Timeframe: 6 weeks

Population: The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The MP was measured before and after treatment during hospitalization.

Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement 1. Flicker of movement only 2. Movement possible when assisted by gravity or gravity is eliminated 3. Movement possible against gravity but without imposed resistance 4. Weak movement possible against gravity 5. 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.

Outcome measures

Outcome measures
Measure	Acupuncture n=7 Participants acupuncture on GV26 and 12 Well points acupuncture: acupuncture on GV26 and 12 Well points	Laser Acupuncture n=9 Participants laser acupuncture on GV26 and 12 Well points laser acupuncture: laser acupuncture on GV26 and 12 Well points	Control Group n=6 Participants laser acupuncture without laser output in control group. control: sham laser acupuncture on GV26 and 12 Well points
Muscle Power (MP)	4.29 units on a scale Standard Deviation 4.46	4.33 units on a scale Standard Deviation 3.39	2.83 units on a scale Standard Deviation 3.49

Adverse Events

Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laser Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wen-Long Hu, Deputy Director, Department of Chinese Medicine

Kaohsiung Chang Gung Memorial Hospital

Phone: +886-7-7317123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place