Skip to content

Dose-response Effects of Electroacupuncture Intensity and Session Frequency in Acute Nonspecific Low Back Pain: A 2×2 Factorial Randomized Controlled Trial

Dose-response Effects of Electroacupuncture Intensity and Session Frequency in Acute Nonspecific Low Back Pain: A 2×2 Factorial Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000595
Enrollment
Unknown
Registered
2026-03-18
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Acute Nonspecific Low Back Pain

Interventions

The high-intensity, high-frequency EA group :The high-intensity electroacupuncture group will receive treatment at a frequency of three times per week.
The high-intensity, low-frequency EA group :The high-intensity electroacupuncture group will receive treatment at a frequency of one time per week.
The low-intensity, high-frequency EA group :The low-intensity electroacupuncture group will receive treatment at a frequency of three times per week.
The low-intensity, low-frequency EA group :The low-intensity electroacupuncture group will receive treatment at a frequency of one time per week.

Sponsors

The Third Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The diagnostic criteria for acute nonspecific LBP will be established in accordance with the Chinese Expert Consensus on the Diagnosis and Treatment of Acute/Chronic Non-Specific Low Back Pain24, the Chinese Clinical Guideline for the Diagnosis and Treatment of Non-Specific Low Back Pain25, and the European Guidelines for the Management of Acute Nonspecific Low Back Pain in Primary Care (COST B13 Working Group)26. 1.Duration of acute nonspecific LBP = 4 weeks. 2.Pain and discomfort of unknown etiology within the region below the costal margin, above the gluteal sulcus, and between the two midaxillary lines, excluding specific spinal pathologies and radicular pain, persisting for at least 1 day, unilateral or bilateral, with or without referred pain to the thigh (above the knee). 3.Clinical features of acute nonspecific LBP: acute onset, often associated with mechanical triggers such as heavy lifting or trunk twisting; pain is often of moderate to severe intensity, possibly accompanied by localized or diffuse tenderness; lumbar movement typically provokes pain, with or without radiation to the lower limbs. 4.No specific abnormalities detected on imaging studies. Inclusion Criteria 1.Diagnosis of acute nonspecific LBP confirmed by a specialist according to the aforementioned diagnostic criteria. 2.Duration of symptoms = 14 days. 3.Age between 18 and 65 years, inclusive, regardless of gender. 4.Pain localized between the T12 vertebra and the gluteal sulcus, primarily of mechanical origin or non-radicular referred pain (proximal to the knee). 5.Average pain intensity = 3 points on the Visual Analogue Scale(VAS) over the past 3 days. 6.Cognitively intact, able to understand and complete relevant questionnaires, and willing to provide informed consent.

Exclusion criteria

Exclusion criteria: 1.Specific LBP (e.g., secondary to neoplastic, infectious, metabolic, rheumatoid arthritis, or fracture-related causes) or presence of radicular symptoms. 2.Spinal deformities (including spondylolisthesis, spondylolysis, or scoliosis). 3.Extraspinal pathologies (e.g., vascular or genitourinary disorders). 4.History of lumbar spine surgery. 5.LBP accompanied by pain in more than two additional anatomical regions. 6.Pregnant or lactation. 7.Severe cardiopulmonary, cerebrovascular, hepatic, renal, or hematopoietic system diseases; malignancy; or systemic organ failure. 8.Bleeding tendency; presence of a cardiac pacemaker or other contraindications to EA; or inability to cooperate with treatment. 9.Significant emotional instability or presence of psychiatric symptoms that may interfere with study procedures. 10.Receipt of any acupuncture-related treatment within 2 weeks prior to enrollment.

Design outcomes

Primary

MeasureTime frame
The overall treatment response rate;

Secondary

MeasureTime frame
Change in visual analogue scale (VAS) scores from baseline at each post-intervention time point;Oswestry Disability Index (ODI);The Japanese Orthopaedic Association (JOA) ;The 36-Item Short-Form Health Survey (SF-36) ;

Countries

China

Contacts

Public ContactLiang Yi

Zhejiang Chinese Medical University

liangyiwww@126.com18057102850

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026