Health TrialsbyHealthPanel

Efficacy of Electroacupuncture Combined With Auricular Acupressure for Chronic Low Back Pain.

ConditionsChronic Low Back Pain (CLBP)Lumbar Spondylosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

Chronic low back pain (CLBP) due to lumbar spondylosis is a leading cause of disability, significantly impacting the quality of life in middle-aged and elderly populations. While electroacupuncture (EA) and auricular acupressure (AA) are recognized as safe, non-pharmacological therapies, high-quality clinical evidence specifically evaluating their combined effects on CLBP patients with TCM "Kidney Yin deficiency" syndrome remains limited.This randomized controlled trial aims to evaluate the efficacy and safety of combining EA with AA (utilizing Vaccaria segetalis seeds) compared to EA combined with sham AA. The study will focus on 76 eligible patients at Le Van Thinh Hospital. Primary objectives are to measure changes in pain intensity (VAS) and functional improvement (ODI) at three intervals: baseline (T0), after 7 days (T1), and upon completion of the 14-day intervention (T2). The findings are expected to provide an evidence-based foundation for an integrated treatment approach to manage chronic lumbar pain effectively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 40 and 70 years.

Low back pain persisting for ≥ 12 weeks.

Pain intensity: 30 ≤ VAS ≤ 70.

Disability index: ODI ≥ 10%.

Disqualifiers

Contraindications to auricular acupressure (e.g., ear skin infection) or electroacupuncture (e.g., pregnancy, severe heart failure, surgical indications, pacemakers, metal implants).

Specific causes of low back pain (e.g., infection, tumor, osteoporosis, ankylosing spondylitis, fracture).

Disc herniation with surgical indications (e.g., muscle atrophy, severe limb weakness, or sphincter dysfunction).

Currently participating in other interventional studies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electroacupuncture

    Device

    Using sterile, single-use 0.30x25mm needles, the investigator will perform acupuncture at Jiaji L2-S1 (Ex-B2), Shenshu (BL23), Weizhong (BL40), Sanyinjiao (SP6), and Fuliu (KI7). A reinforcing method will be applied with perpendicular insertion at a depth of 0.4 - 0.8 cm. After achieving the 'Deqi' sensation, needles will be connected to a KWD-808-I device to deliver a biphasic spike pulse (continuous wave) at a frequency of 100Hz for 20 minutes, with intensity adjusted to patient tolerance.

  • Auricular Acupressure

    Device

    Using Vaccaria segetalis seeds at Shenmen (TF4), Subcortex (AT4), Lumbar spine (AH9), Kidney (CO10). The seeds are applied using skin-colored adhesive patches. The acupuncturist will manually press each ear point for 5 minutes during the electroacupuncture session (total 20 mins). Frequency: 1 session/day, 5 sessions/week, for 2 weeks.

  • Sham Auricular Acupressure

    Device

    Using the exact same Vaccaria segetalis seeds and identical adhesive patches to ensure participants cannot visually or physically tell the difference from the real treatment. Seeds are placed at non-specific points: Anus (HX5), Shoulder (SF4), Lung (CO14), Tooth (LO1). The acupuncturist will manually press each point for 5 minutes (total 20 mins). Frequency: 1 session/day, 5 sessions/week, for 2 weeks.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 2 interventions
Group B: Sham Comparator GroupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

The change of the Visual Analog Scale (VAS) Score

Change in Pain Intensity measured by the Visual Analog Scale (VAS) Pain intensity will be assessed using a Visual Analogue Scale (VAS). It consists of a 100 mm horizontal line, without graduations, anchored at each end by descriptors: "0 mm" indicating "no pain" and "100 mm" indicating "worst possible pain". Pain Classification: Patients will be classified into 4 categories based on their measured VAS scores: 0 mm (No pain), 1 - 30 mm (Mild pain), 31 - 70 mm (Moderate pain), and 71 - 100 mm (Severe pain, including very severe and worst possible pain).

Time frame
Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).

Secondary outcomes

1

The change of the Oswestry Disability Index (ODI) percentage

Functional disability assessed using the full 10-item questionnaire (including Pain intensity, Personal care, Lifting, Walking, Sitting, Standing, Sleeping, Sex life, Social life, and Traveling). Each item is scored from 0 to 5, and the total score is converted to a percentage (0-100%). Higher percentages indicate greater functional disability.

Time frame
Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2).
2

Incidence of intervention-related adverse events

The study will closely monitor and document any unexpected adverse events associated with the procedure. These include bleeding, needle breakage, intolerable pain, vasovagal response (needle fainting), allergic contact dermatitis at the seed application site, or subcutaneous hemorrhage.

Time frame
Monitored continuously throughout the 14-day intervention period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Medicine and Pharmacy at Ho Chi Minh City

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: