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A randomized, open, parallel-controlled clinical trial evaluated the efficacy and safety of the intelligent non-invasive electro-acupuncture device in the treatment of patients with chronic nonspecific low back pain.

A randomized, open, parallel-controlled clinical trial evaluated the efficacy and safety of the intelligent non-invasive electro-acupuncture device in the treatment of patients with chronic nonspecific low back pain.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001561
Enrollment
Unknown
Registered
2026-06-23
Start date
2024-07-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic nonspecific low back pain

Interventions

Sponsors

Anhui Provincial Hefei, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 81 Years

Inclusion criteria

Inclusion criteria: 1) Age = 18 years old; 2) Patients with chronic nonspecific low back pain as diagnosed clinically; 3) Those who voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Within one week prior to enrollment, the participant was receiving other analgesic treatments or had other conditions that might affect the evaluation of acupuncture efficacy; 2) Not meeting the diagnostic criteria for NSLBP, or having concurrent spinal-related diseases (congenital deformity, spinal canal stenosis, lumbar tumor, lumbar tuberculosis, ankylosing spondylitis, lumbar fractures, etc., causing pain due to lumbar lesions); 3) Had undergone lumbar surgery; 4) Had poor general condition, severe cardiovascular and cerebrovascular, liver and kidney organ diseases, and/or had a history of coagulation dysfunction; 5) Had epilepsy, mental abnormalities, confusion, cognitive and communication disorders, or patients with spastic paralysis, abnormal neural stress response, or those with excessive mental tension and incompatibility; 6) Had acute suppurative inflammation or ulcers at the treatment site; 7) Had been intoxicated, overfed, underfed, overworked, extremely thirsty, excessive sweating, or excessive bleeding; 8) Had implanted implantable electronic medical devices such as cardiac pacemakers; 9) Had participated in other clinical trials related to acupuncture and massage for treating low back pain in the past two months; 10) Were pregnant or lactating women; 11) Other research personnel considered not suitable for participating in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Overall efficiency evaluation;

Secondary

MeasureTime frame
Visual Analogue Scale;Oswestry Disability Index;The effectiveness rate after the first treatment period;increasingly efficient;

Countries

China

Contacts

Public Contactxiaohongbo

Anhui Provincial Hefei, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

2845134995@qq.com13505696689

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026