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Spinal Cord Injuries (SCI)NCT06509841

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

A study testing Electro-acupuncture at the Jiaji points and Electro-acupuncture at the scalp points in people with Spinal Cord Injuries (SCI), run by Hangzhou Medical College at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries (SCI)
What is being tested?
Electro-acupuncture at the Jiaji points and Electro-acupuncture at the scalp points
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
1 May 2024to 30 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Hangzhou, Zhejiang, 311000

Other trials in China

About this study

Official title: The Impact of Jiaji Electroacupuncture and Scalp Electroacupuncture on Traumatic Spinal Cord Injury: A Randomized Controlled Trial

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.

Read the detailed description

The motor function score, light touch score, and pinprick sensation score of both groups showed significant improvement ( P < 0.001). When comparing Group A and Group B, there was no statistically significant difference in ASIA grade improvement at week 4 ( P > 0.05), but at week 8 and the 3-month follow-up, the proportion of ASIA grade improvement in Group A was significantly higher than that in Group B (week 8: 40.48% vs. 14.29%, P=0.007; 3-month follow-up: 47.62% vs. 21.43%, P = 0.012). At week 4, week 8, and the 3-month follow-up, Group A's motor function score, light touch score, pinprick sensation score, and MBI were all higher than those of Group B ( P < 0.05).

Being tested
Electro-acupuncture at the Jiaji points, Electro-acupuncture at the scalp points
Keywords
spinal cord injury, electroacupuncture, Jiaji acupoint, scalp acupuncture, clinical efficacy
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electro-acupuncture at the Jiaji pointsOther

    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.

  • Electro-acupuncture at the scalp pointsOther

    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.

Study groups in NCT06509841
Study groupRoleWhat they receive
Scalp electro-acupunctureExperimentalRecruiting patients receiving electro-acupuncture at the Scalp points
Receives: Other: Electro-acupuncture at the scalp points
Jiaji electro-acupunctureExperimentalRecruited patients receiving electro-acupuncture at the Jiaji points
Receives: Other: Electro-acupuncture at the Jiaji points

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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%.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 May 2024
  3. Primary completion1 Mar 2025
  4. Study completion30 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509841
Sponsor's protocol ID
202401
Status last verified
Jul 2022
First submitted
6 Jul 2024
Last updated
7 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31767947

  • 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.

    PubMed 17908569

  • 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.

    PubMed 31772592

  • 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.

    PubMed 33061954

  • 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.

    PubMed 34987595

  • 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.

    PubMed 35462893

  • 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.

    PubMed 36188361

  • 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.

    PubMed 29753705

  • 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.

    PubMed 33686304

Questions about this trial

What is this clinical trial studying?

A study testing Electro-acupuncture at the Jiaji points and Electro-acupuncture at the scalp points in people with Spinal Cord Injuries (SCI), run by Hangzhou Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ASIA Score (time frame: 0 week, 4 weeks, 8 weeks, and 3 months of follow-up (3 months after the end of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06509841, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.

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