A Randomized Controlled Trial of Auricular Thumbtack Needle Therapy Combined With Conventional Treatment and Median Nerve Electrical Stimulation on Consciousness Recovery Prognosis and Family Satisfaction in Craniocerebral Injury Patients With Consciousness Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Awakening Rate of Patients with Consciousness Disorder After Traumatic Brain Injury (TBI)
Study Overview
Brief Summary
This study aims to evaluate the effects of auricular press needle therapy, combined with conventional treatment and median nerve electrical stimulation, on promoting arousal and neurological recovery in patients with disorders of consciousness after traumatic brain injury.
Sixty patients with a Glasgow Coma Scale (GCS) score of 4-8 were enrolled and randomly assigned in a 1:1 ratio to a control group or an experimental group (30 patients each). Both groups received standard conventional treatment (including surgery when indicated, medications, nutritional support, acupuncture, and complication prevention) combined with median nerve electrical stimulation. The experimental group received auricular press needle therapy (at Heart, Shenmen, Sympathetic, and Subcortex acupoints) on top of the same interventions, and family members were trained to perform daily acupoint massage.
The GCS score and Coma Recovery Scale-Revised (CRS-R) score were assessed at baseline, 4 weeks, 6 weeks, and 8 weeks after the start of intervention, and the arousal rate was recorded. The Glasgow Outcome Scale (GOS) was used to evaluate prognosis at 1 month after the end of treatment, and family satisfaction was assessed using a Likert scale at 8 weeks post-intervention. Data were analyzed using SPSS Statistics 27.0, with statistical significance set at p < 0.05.
Detailed Description
This was a single-center, parallel-group, randomized controlled trial. Patients were stratified by injury severity according to the Glasgow Coma Scale (GCS 4-6 versus 7-8) and randomized 1:1 using a computer-generated sequence produced by an independent statistician.
Allocation was concealed with sequentially numbered opaque sealed envelopes opened only after informed consent had been signed by legal guardians.
Blinding of patients, families, and therapists was not feasible due to the visible auricular needles and stimulation device. Outcome assessors remained blinded throughout; they received uniform training, used scoring forms without intervention information, and were regularly supervised.
Both groups received conventional treatment (surgery when indicated, medication, nutritional support, acupuncture, and complication prevention) plus right median nerve electrical stimulation twice daily for 8 weeks (40 Hz, 300 ms pulse width, intensity gradually increased to 20 mA). The experimental group additionally received auricular press needle therapy at Heart, Shenmen, Sympathetic, and Subcortex acupoints (disposable sterile needles, 3 days on/1 day off cycle, repeated throughout the 8 weeks), with family members trained to massage the points three times daily for 10 minutes.
All staff completed standardized training and passed competency checks. Weekly supervision by a senior neurosurgeon ensured treatment fidelity, data integrity, and family compliance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 86 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Disorder of consciousness following traumatic brain injury
- •Stable vital signs with no evidence of active bleeding
- •Glasgow Coma Scale (GCS) score between 4 and 8 (inclusive)
- •No severe vital organ dysfunction and normal cardiac function
- •Time from injury to enrollment ≤ 10 days
- •No prior history of traumatic brain injury, epilepsy, or pregnancy
Exclusion Criteria
- •Presence of other critical illnesses (e.g., severe cardiovascular, hepatic, or renal disease)
- •Known allergy to the electrodes or adhesive patches used in electrical stimulation
- •Lack of cooperation or refusal by the patient's legal guardian/family members
Outcomes
Primary Outcomes
Awakening Rate of Patients with Consciousness Disorder After Traumatic Brain Injury (TBI)
Time Frame: 8 weeks after the start of the intervention (which is the end of the full intervention course for the study).
1. Description Primary outcome is awakening rate at 8 weeks post-intervention in TBI patients with consciousness disorder (GCS 4-8). "Awakening" = independent eye-opening ≥30s, or clear responses (limb retraction, simple verbal answers) to verbal/pain stimuli, confirmed by 2 attending physicians. 2. Time Frame 8 weeks after intervention start (end of full course). 3. Assessment Method Record weekly awakening status during 8-week intervention; Count awakened patients in Arm 1 (control) and Arm 2 (experimental) at week 8; Calculate rate: (Awakened patients / Total patients per group) × 100%. 4. Rationale Awakening is core rehabilitation goal for these patients, directly reflecting intervention efficacy in consciousness recovery. More intuitive and clinically meaningful than other indicators (e.g., GCS) for evaluating core therapeutic effect.
Secondary Outcomes
- Change in Glasgow Coma Scale (GCS) Score(Baseline (pre-intervention), 4 weeks, 6 weeks, 8 weeks post-intervention.)
Investigators
Li Hai
Chief Therapist, Department of Rehabilitation
First Affiliated Hospital of Gannan Medical University