The Impact of Jiaji Electroacupuncture and Scalp Electroacupuncture on Traumatic Spinal Cord Injury

NCT06509841 | Completed DMC

• 1 other identifier: 202401
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury (SCI), leads to functional deficits and complications like neurogenic bladder and deep vein thrombosis, imposing a global annual financial burden. This trial aims to compares Jiaji electroacupuncture (JEA) and scalp electroacupuncture (SEA) in SCI rehabilitation. This randomized controlled trial (RCT) compared JEA and SEA in SCI rehabilitation.

Conditions

Spinal Cord Injuries (SCI)

Keywords

spinal cord injury; electroacupuncture; Jiaji acupoint; scalp acupuncture; clinical efficacy

Outcome Measures

Primary Outcomes (3)

• ASIA Score

  The ASIA score for spinal cord injury, established by the American Spinal Injury Association, serves as a method to assess the severity of spinal cord injuries and functional recovery. It includes evaluations of the patient's neurological motor function, light touch sensation score, pinprick sensation score, and sphincter function performance. The ASIA score categorizes spinal cord injuries into five grades: 1/A, 2/B, 3/C, 4/D, and 5/E. A lower grade indicates a more severe injury, characterized by weaker motor and sensory scores, including light touch and pinprick sensation scores.

  0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)

• Modified Barthel Index

  The Modified Barthel Index Rating Scale is a tool used to assess adults' abilities to perform activities of daily living. It comprises 10 assessment items, including feeding, bathing, grooming, dressing, and controlling bowel and bladder movements. Each item is divided into different levels corresponding to various scores, with a maximum score of 100. A score of ≥60 indicates mild functional impairment, a score of 59-41 indicates moderate functional impairment, and a score of ≤40 indicates severe functional impairment.

  0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)

• Incidence of Complications

  Monitor whether patients experience severe bleeding, pressure ulcers, deep vein thrombosis, neurogenic bowel dysfunction, neurogenic bladder, nephropathy, pulmonary infections, traumatic encephalopathy, pain, and other complications during the treatment and follow-up periods. Record the number of patients with each type of complication. The incidence rate of complications is calculated as follows: (Total number of cases with a specific complication in each group) ÷ (Total number of patients in that group) × 100%.

  0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)

Study Arms (2)

Scalp electro-acupuncture

EXPERIMENTAL

Recruiting patients receiving electro-acupuncture at the Scalp points

Other: Electro-acupuncture at the scalp points

Jiaji electro-acupuncture

EXPERIMENTAL

Recruited patients receiving electro-acupuncture at the Jiaji points

Other: Electro-acupuncture at the Jiaji points

Interventions

Electro-acupuncture at the Jiaji points OTHER

Adopting treatments for the group that received electro-acupuncture at the Jiaji points, including: ① electro-acupuncture at the Jiaji points with continuous treatment for 8 weeks.

Jiaji electro-acupuncture

Electro-acupuncture at the scalp points OTHER

Adopting treatments for the group that received electro-acupuncture at the Scalp points, including: ① electro-acupuncture at the Scalp points with continuous treatment for 8 weeks.

Scalp electro-acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The duration of spinal cord injury must be between 3 to 6 months;
• The site of injury must be clearly defined;
• The cause of injury must be traumatic;
• Patients must be over 18 years of age;
• Patients must provide consent to participate in this study.

You may not qualify if:

• Unknown time or site of injury;
• Disagreement to participate in this study;
• Patients with contraindications for acupuncture intervention (such as skin lesions or rashes at potential acupuncture sites);
• Patients with cognitive or language impairments who are unable to cooperate with scale evaluations.

Sponsors & Collaborators

• Hangzhou Medical College: lead

Study Sites (1)

the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.

Hangzhou, Zhejiang, 311000, China

Location

Related Publications (9)

• Lucci VM, McGrath MS, Inskip JA, Sarveswaran S, Willms R, Claydon VE. Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial. Spinal Cord. 2020 Apr;58(4):430-440. doi: 10.1038/s41393-019-0381-2. Epub 2019 Nov 25.

  PMID: 31767947 BACKGROUND

• Dyson-Hudson TA, Kadar P, LaFountaine M, Emmons R, Kirshblum SC, Tulsky D, Komaroff E. Acupuncture for chronic shoulder pain in persons with spinal cord injury: a small-scale clinical trial. Arch Phys Med Rehabil. 2007 Oct;88(10):1276-83. doi: 10.1016/j.apmr.2007.06.014.

  PMID: 17908569 BACKGROUND

• Xiong F, Fu C, Zhang Q, Peng L, Liang Z, Chen L, He C, Wei Q. The Effect of Different Acupuncture Therapies on Neurological Recovery in Spinal Cord Injury: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2019 Oct 27;2019:2371084. doi: 10.1155/2019/2371084. eCollection 2019.

  PMID: 31772592 BACKGROUND

• Tang H, Guo Y, Zhao Y, Wang S, Wang J, Li W, Qin S, Gong Y, Fan W, Chen Z, Guo Y, Xu Z, Fang Y. Effects and Mechanisms of Acupuncture Combined with Mesenchymal Stem Cell Transplantation on Neural Recovery after Spinal Cord Injury: Progress and Prospects. Neural Plast. 2020 Sep 25;2020:8890655. doi: 10.1155/2020/8890655. eCollection 2020.

  PMID: 33061954 BACKGROUND

• Xiong F, Lu J, Pan H, Wang F, Huang Y, Liu Y, Li L, Zhang R, Wang Y, He C, Quan W. Effect of Specific Acupuncture Therapy Combined with Rehabilitation Training on Incomplete Spinal Cord Injury: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2021 Dec 26;2021:5671998. doi: 10.1155/2021/5671998. eCollection 2021.

  PMID: 34987595 BACKGROUND

• Jiang K, Sun Y, Chen X. Mechanism Underlying Acupuncture Therapy in Spinal Cord Injury: A Narrative Overview of Preclinical Studies. Front Pharmacol. 2022 Apr 7;13:875103. doi: 10.3389/fphar.2022.875103. eCollection 2022.

  PMID: 35462893 BACKGROUND

• Huang Y, He K, Fang D, Ni F, Qiu B, Liang K, Ma R. A bibliometric of research trends in acupuncture for spinal cord injury: Quantitative and qualitative analyses. Front Neurol. 2022 Sep 15;13:936744. doi: 10.3389/fneur.2022.936744. eCollection 2022.

  PMID: 36188361 BACKGROUND

• Fan Q, Cavus O, Xiong L, Xia Y. Spinal Cord Injury: How Could Acupuncture Help? J Acupunct Meridian Stud. 2018 Aug;11(4):124-132. doi: 10.1016/j.jams.2018.05.002. Epub 2018 May 30.

  PMID: 29753705 BACKGROUND

• Inzani F, Rindi G. Introduction to neuroendocrine neoplasms of the digestive system: definition and classification. Pathologica. 2021 Feb;113(1):1-4. doi: 10.32074/1591-951X-227.

  PMID: 33686304 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 19, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 30, 2025
• Last Updated: May 7, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)