Chronic Low Back Pain (Non-specific, Uncomplicated)AA for CLBPNCT07829289
Auricular Acupressure for Chronic Low Back Pain in Postmenopausal Women
A study testing auricular acupressure in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by Chia Fen Wu at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Chronic Low Back Pain (Non-specific, Uncomplicated)
- What is being tested?
- auricular acupressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 50-65 years
- Chronic low back pain lasting longer than 12 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Auricular Acupressure for Chronic Low Back Pain and Related Symptoms in Postmenopausal Women
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.
- Being tested
- auricular acupressure, sham auricular acupressure
- Keywords
- menopausal symptom, chronic low back pain, auricular acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureDevice
The experimental group received auricular acupressure at the Shenmen, Sympathetic, Subcortes, and Lower Back Points for four weeks.
sham auricular acupressureDevice
the control group received auricular acupressure at the Stomach, Mouth, Duodenum, and Tonsil points for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupressure | Experimental | Not described Receives: Device: auricular acupressure |
| sham auricular acupressure | Sham comparator | Not described Receives: Device: sham auricular acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).
Secondary outcomes (1)
the Greene Climacteric Scale
The scale consists of 21 items that assess the severity of menopausal symptoms experienced during the past month. Each item is rated on a 4-point scale: 0 indicates "not at all," 1 indicates "occasionally," 2 indicates "frequently," and 3 indicates "all the time." The total score is calculated by summing the scores across all domains. Higher scores indicate greater severity of menopausal symptoms.
Measured: Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start14 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (Non-specific, Uncomplicated)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Fen Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chia Fen Wu, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829289
- Sponsor's protocol ID
- KMUHIRB-F(II)-20250375
- Acronym
- AA for CLBP
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent form and IRB-approved protocol did not include permission to share individual participant data with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auricular Acupressure for Chronic Low Back Pain and Related Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07829289
- Acronym / sponsor ID
- AA for CLBP / KMUHIRB-F(II)-20250375
- Keywords
- menopausal symptom, chronic low back pain, auricular acupressure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chia Fen WuUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupressure | Experimental | Device: auricular acupressure |
| sham auricular acupressure | Sham comparator | Device: sham auricular acupressure |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 50-65 years
- Chronic low back pain lasting longer than 12 weeks
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular acupressureThe experimental group received auricular acupressure at the Shenmen, Sympathetic, Subcortes, and Lower Back Points for four weeks. | Device | Auricular Acupressure |
| sham auricular acupressurethe control group received auricular acupressure at the Stomach, Mouth, Duodenum, and Tonsil points for four weeks. | Device | sham auricular acupressure |
Primary outcome
The Chinese Roland-Morris Disability Questionnaire
Time frame: Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).
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.
Brief Pain Invetory- Taiwan Form, BQT, BPI-T
Time frame: Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).
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.
1 secondary outcome
the Greene Climacteric Scale
Time frame: Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. The informed consent form and IRB-approved protocol did not include permission to share individual participant data with external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupressure in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by Chia Fen Wu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Chinese Roland-Morris Disability Questionnaire (time frame: Baseline(T0), immediately post-intervention (T1), 2-week follow-up (T2), and 4-week follow-up (T3).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.