Auricular Acupressure for Chronic Low Back Pain in Postmenopausal Women

NCT07829289 | Enrolling By Invitation

• 1 other identifier: KMUHIRB-F(II)-20250375
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Participants were recruited from two areas in southern Taiwan: the traditional Chinese medicine outpatient clinics at Kaohsiung Medical University Chung-Ho Memorial Hospital and Kaohsiung Municipal Siaogang Hospital, as well as community-based traditional Chinese medicine clinics. Individuals interested in participating were interviewed in the research office on the same day. The inclusion criteria were: (1) women aged 50-65 years and (2) low back pain lasting longer than 12 weeks.

Conditions

Chronic Low Back Pain (Non-specific, Uncomplicated)

Keywords

menopausal symptom; chronic low back pain; auricular acupressure

Outcome Measures

Primary Outcomes (2)

• The Chinese Roland-Morris Disability Questionnaire

  The questionnaire consists of 24 self-reported items assessing the impact of low back pain on daily functioning. Each item is answered as either "Yes" or "No," with "Yes" scored as 1 and "No" scored as 0. Higher total scores indicate greater functional disability.

  Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).

• Brief Pain Invetory- Taiwan Form, BQT, BPI-T

  The scale consists of two sections with a total of 11 items. The first section, pain severity, consists of four items that assess the severity of pain in individuals with low back pain. The second section, pain interference, consists of seven items that assess the extent to which pain interferes with daily functioning. Each item is rated on an 11-point numeric rating scale ranging from 0 to 10, with 0 indicating no impact and 10 indicating extreme impact. Scores of 1-4 indicate mild severity, scores of 5-6 indicate moderate severity, and scores of 7 or higher indicate severe severity. Higher scores indicate greater pain severity or greater interference with daily functioning.

  Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).

Secondary Outcomes (1)

• the Greene Climacteric Scale

  Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).

Study Arms (2)

Auricular Acupressure

EXPERIMENTAL

Device: auricular acupressure

sham auricular acupressure

SHAM COMPARATOR

Device: sham auricular acupressure

Interventions

auricular acupressure DEVICE

The experimental group received auricular acupressure at the Shenmen, Sympathetic, Subcortes, and Lower Back Points for four weeks.

Auricular Acupressure

sham auricular acupressure DEVICE

the control group received auricular acupressure at the Stomach, Mouth, Duodenum, and Tonsil points for four weeks.

sham auricular acupressure

Eligibility Criteria

• Age: 50 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 50-65 years
• Chronic low back pain lasting longer than 12 weeks

You may not qualify if:

• Unable to read
• Cardiovascular conditions, including cardiac arrhythmia, heart failure, or coronary artery disease
• Malignant tumor
• Infection or open skin lesion on or around the ear
• Previous lumbar spine surgery

Sponsors & Collaborators

• Chia Fen Wu: lead

Study Sites (1)

100 Shih-Chuan 1st Rd.

Kaohsiung City, Sanmin District, 80708, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Women aged 50-65 years with physician-diagnosed nonspecific low back pain lasting longer than 12 weeks were recruited from traditional Chinese medicine outpatient clinics at two medical centers and community clinics in southern Taiwan. After providing written informed consent and completing baseline assessments, participants were randomly assigned to the intervention or control group using computer-generated allocation sequences concealed in opaque, sealed envelopes. A qualified traditional Chinese medicine nurse administered the assigned four-week auricular acupressure intervention. The Greene Climacteric Scale, Chinese Brief Pain Inventory, and Roland-Morris Disability Questionnaire were administered at baseline, immediately after the intervention, and at two- and four-week follow-ups.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 21, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)