Chronic Low Back Pain (CLBP), Lumbar Spondylosis
Conditions
Keywords
Electroacupuncture, Auricular Acupressure, Kidney Yin Deficiency
Brief summary
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.
Detailed description
76 eligible patients with CLBP due to lumbar spondylosis (Kidney Yin deficiency syndrome) will be enrolled in this study. Participants will be randomly assigned to either the experimental or control group using a computer-generated randomization list (Microsoft Excel 365) with a 1:1 allocation ratio. Allocation concealment will be ensured using opaque, sealed envelopes. * The experimental group will receive 20 minutes of electroacupuncture combined with auricular acupressure at Shenmen (TF4), Subcortex (AT4), Lumbar spine (AH9), and Kidney (CO10) acupoints. * The control group will receive 20 minutes of electroacupuncture combined with sham auricular acupressure at Anus (HX5), Shoulder (SF4), Lung (CO14), and Tooth (LO1) acupoints. * Both groups will undergo interventions once a day, 5 times a week, for 2 weeks (total 10 sessions). Clinical outcomes including the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and adverse events will be evaluated at baseline (T0), day 7 (T1), and day 14 (T2).
Interventions
DEVICEElectroacupuncture
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.
DEVICEAuricular Acupressure
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.
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants in both groups receive identical patches and seeds, differing only in acupoint locations to ensure blinding. Outcome assessors and data analysts are blinded to group assignments. The acupuncturist, who also performs the seed pressing instead of the participants, is not blinded.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age between 40 and 70 years. * Low back pain persisting for ≥ 12 weeks. * Pain intensity: 30 ≤ VAS ≤ 70. * Disability index: ODI ≥ 10%. * Diagnosed with Lumbar Spondylosis by a physician, supported by clinical signs (mechanical pain) and imaging (X-ray or MRI showing degeneration). * Diagnosed with Kidney Yin deficiency syndrome by a certified TCM physician, exhibiting symptoms such as: lower back/knee soreness, afternoon fever/hot flashes, night sweats, tinnitus, dry mouth, red tongue, or rapid/fine pulse. * Voluntary consent to participate.
Exclusion criteria
* 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. * Currently taking medications that may affect study outcomes (painkillers, muscle relaxants, antidepressants, TCM drugs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of the Visual Analog Scale (VAS) Score | Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of the Oswestry Disability Index (ODI) percentage | Assessments are conducted before intervention and after each intervention week: Baseline (T0), Day 7 (T1), and Day 14 (T2). | 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. |
| Incidence of intervention-related adverse events | Monitored continuously throughout the 14-day intervention period. | 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. |
Countries
Vietnam
Outcome results
None listed