Chronic Non-Specific Low Back PainNCT06682273
Thread-embedding Combined With Auricular Acupuncture for Non-specific Chronic Low Back Pain
A study testing Thread-embedding acupuncture and Auricular acupuncture in people with Chronic Non-Specific Low Back Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Low back pain (LBP) is a significant global health issue, with cases expected to rise by 36.4% by 2050. Chronic LBP (cLBP), lasting over three months, is mostly non-specific cLBP (cNLBP), posing a challenge for effective management. Common treatments include medication, exercise, and acupuncture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-Specific Low Back Pain
- What is being tested?
- Thread-embedding acupuncture and Auricular acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteVietnam
- Study dates
- 11 Nov 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with low back pain at the outpatient clinic.
- Diagnosed with non-specific low back pain persisting for more than 3 months, without radiation to the legs.
- Pain-NRS score ≥ 4 on a 10-point scale.
- Independent ambulation capability (with or without walking aids).
- Consent to participate in the study.
Who cannot join
- History of prior lumbar spine surgery.
- Known or suspected severe spinal conditions (e.g., cancer, vertebral fracture, spinal infection, or cauda equina syndrome).
- Signs of concurrent involvement of lumbar nerve roots, plexus, sciatic nerve, other leg nerves, or diagnosed polyneuropathy confirmed by electrodiagnosis.
- Presence of systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis.
- Unstable or untreated severe health conditions (such as end-stage renal disease, advanced liver failure, NYHA class IV heart failure).
- Alcohol abuse or substance dependence.
Show all 11Show fewer
- Use of anti-inflammatory medication within 2 weeks prior to enrollment.
- Acupuncture treatment within the past 4 weeks.
- Previous treatment with thread-embedding or auricular acupuncture for any condition.
- Damaged skin in the acupuncture area or history of hypersensitivity reactions to acupuncture.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combination of Thread-embedding and Auricular Acupuncture in the Treatment of Non-specific Chronic Low Back Pain
Low back pain (LBP) is a significant global health issue, with cases expected to rise by 36.4% by 2050. Chronic LBP (cLBP), lasting over three months, is mostly non-specific cLBP (cNLBP), posing a challenge for effective management. Common treatments include medication, exercise, and acupuncture.
This study explores the combined use of thread-embedding and auricular acupuncture for treating cNLBP, as combining these methods is thought to enhance effectiveness. Participants with cNLBP will be randomized into four groups to receive either the combination of both treatments, each treatment individually with a sham, or both shams. The study will last eight weeks, with four weeks of intervention and four weeks of follow-up. Treatment outcomes, including pain, disability, medication use, and quality of life, will be evaluated, along with monitoring for adverse effects.
Read the detailed description
Low back pain (LBP) is a major public health issue worldwide. In 2020, there were over half a billion cases of LBP globally, and by 2050, the total number of LBP cases is expected to increase by 36.4% worldwide. LBP accounts for 7.7% of total Years Lived with Disability, making it the largest contributor to the global disability burden.
When lasting three months or more, LBP is classified as chronic (cLBP). Most cLBP is non-specific cLBP (cNLBP). Managing cNLBP remains challenging. Recommended therapies include short-term medication, manipulation, supervised exercise, cognitive behavioral therapy, and multidisciplinary treatment. According to the Clinical Practice Guideline from the American College of Physicians, clinicians and patients should initially consider non-pharmacologic treatments, including acupuncture as one of the options.
There is evidence regarding the effectiveness of thread-embedding acupuncture (TEA) and auricular acupuncture (AA) in the treatment of cNLBP. TEA uses the principle of selecting points on the body, while AA involves selecting points on the ear. The difference in the point selection principles of these two methods has led clinicians to often combine them in hopes of enhancing treatment efficacy. However, evidence on the effectiveness of combining these two methods in treating cNLBP remains lacking. This study aims to clarify whether the combination of these methods is more effective than using them individually.
Eligible participants with cNLBP, defined as LBP lasting more than three months without any reasonable explanation and determined by a physician to be nonspecific, will be enrolled and subsequently randomized into four groups: receiving the combination of TEA and AA (TEA + AA group), receiving TEA and sham AA (TEA + sham AA group), receiving AA and sham TEA (AA + sham TEA group), and receiving sham TEA and sham AA (Sham both group), with a 1:1:1:1 allocation ratio.
The study will last for eight weeks, with four weeks of intervention and four weeks of follow-up. AA and sham AA will be administered weekly during the four-week intervention (four sessions). TEA and sham TEA will be administered every two weeks during the four-week intervention (two sessions). Data on treatment efficacy will include disability index, pain score, amount of analgesic medication needed, quality of life score, and global improvement. Additionally, adverse effects will be monitored and recorded.
- Conditions
- Chronic Non-Specific Low Back Pain
- Being tested
- Thread-embedding acupuncture, Auricular acupuncture, Sham thread-embedding acupuncture, Sham auricular acupuncture
- Keywords
- acupuncture, thread embedding acupuncture, auricular acupuncture, low back pain, traditional medicine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread-embedding acupunctureOther
Thread-embedding acupuncture is performed every week for 4 weeks, using a single Polydioxaone thread inserted into acupoints on the body through the needle. After the thread is inserted, the needle will be immediately withdrawn.
Auricular acupunctureOther
Auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into therapeutic points on the ear. The patches with the needle will remain in place for one week.
Sham thread-embedding acupunctureOther
Sham thread-embedding acupuncture is performed every week for 4 weeks, using the needle without thread inserted into acupoints on the body. After insertion, the needle will be immediately withdrawn, and no thread will be left in the body.
Sham auricular acupunctureOther
Sham auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into non-therapeutic points on the ear. The patches with the needle will remain in place for one week.
| Study group | Role | What they receive |
|---|---|---|
| TEA + AA | Experimental | Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with auricular acupuncture (AA) every week in 4 weeks (4 sessions). Receives: Other: Thread-embedding acupuncture; Other: Auricular acupuncture |
| TEA + sham AA | Active comparator | Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions). Receives: Other: Thread-embedding acupuncture; Other: Sham auricular acupuncture |
| AA + sham TEA | Active comparator | Auricular acupuncture (AA) every week in 4 weeks (4 sessions). Combined with sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions). Receives: Other: Auricular acupuncture; Other: Sham thread-embedding acupuncture |
| Sham both | Sham comparator | Sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions). Receives: Other: Sham thread-embedding acupuncture; Other: Sham auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index (ODI) percentage score
The Oswestry Disability Index (ODI) percentage score evaluates the impact of low back pain on various activities (sleeping, self-care, sex life, social life, and traveling) using six rating options (0 to 5). Participants select the most appropriate response, and the total score is calculated as a percentage of the maximum possible score (50 if all sections are completed). A score of zero indicates no disability, while a score of 100% implies significant disability.
Measured: Week 0, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes (5)
Change in pain score on the Numeric Rating Scale (NRS)
The pain score on the Numeric Rating Scale (NRS) is a subjective measure used to assess the intensity of pain experienced by an individual. Participants are asked to rate their pain on a scale from 0 to 10, where 0 represents no pain and 10 indicates the worst possible pain.
Measured: Week 0, Week 2, Week 4, Week 6, and Week 8
Change in the number of paracetamol tablets used
The number of paracetamol 500mg tablets used per week will be recorded.
Measured: Week 2, Week 4, Week 6, and Week 8
Change in the Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS-GH-10) score
The Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS-GH-10) is a 10-item assessment tool that includes ratings for four general items (health, quality of life, physical health, and mental health) and six additional items covering five health domains: physical function (1 item), fatigue (1 item), pain (1 item), emotional distress (1 item), and social health (2 items). Each question has five response options ranging from 1 to 5, except for the pain scale, which ranges from 0 to 10. The total score ranges from 9 to 55, with higher scores indicating better quality of life.
Measured: Week 0, Week 2, Week 4, Week 6, and Week 8
Global improvement rate
Global improvement is assessed through the patients global impression of change, using a 7-point scale: 1 = completely recovered, 2 = greatly improved, 3 = somewhat improved, 4 = no change, 5 = somewhat worse, 6 = significantly worse, and 7 = extremely worsened. Participants who score 1 or 2 are considered improved, those with scores of 3 to 5 are classified as unchanged, and scores of 6 or 7 indicate deterioration.
Measured: Week 2, Week 4, Week 6, and Week 8
Proportion of intervention-related adverse events
For thread-embedding acupuncture and sham thread-embedding acupuncture, anticipated adverse events include local discomfort, an increase in body temperature following treatment, local hematoma or subcutaneous bleeding, local swelling, induration, pain, redness, infection, abscess, itching, and anaphylaxis. Anticipated adverse events for auricular acupuncture and sham auricular acupuncture include pain at the insertion site, local discomfort, skin irritation (itching and redness), local inflammation and bleeding, chondritis, dizziness, nausea, and hypersensitivity reactions. Additionally, any unforeseen adverse events related to these procedures are documented and monitored.
Measured: Up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start11 Nov 2024
- Primary completion20 Feb 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-Specific Low Back PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tin Trong Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682273
- Sponsor's protocol ID
- 273HDDD-GD
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hunter RF, McDonough SM, Bradbury I, Liddle SD, Walsh DM, Dhamija S, Glasgow P, Gormley G, McCann SM, Park J, Hurley DA, Delitto A, Baxter GD. Exercise and Auricular Acupuncture for Chronic Low-back Pain: A Feasibility Randomized-controlled Trial. Clin J Pain. 2012 Mar-Apr;28(3):259-67. doi: 10.1097/AJP.0b013e3182274018.
PubMed 21753728Lee HJ, Choi BI, Jun S, Park MS, Oh SJ, Lee JH, Gong HM, Kim JS, Lee YJ, Jung SY, Han CH. Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial. Trials. 2018 Dec 12;19(1):680. doi: 10.1186/s13063-018-3049-x.
PubMed 30541604Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
PubMed 11074683Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J. 2010 Sep;19(9):1484-94. doi: 10.1007/s00586-010-1353-6. Epub 2010 Apr 17.
PubMed 20397032Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
PubMed 16320034Pham TL, Le NT, Nguyen TT, Chu H. Should thread-embedding and auricular acupuncture be combined rather than used individually for non-specific chronic low back pain?: A double-blinded, randomized, sham-controlled trial. Integr Med Res. 2025 Sep;14(3):101180. doi: 10.1016/j.imr.2025.101180. Epub 2025 Jun 13.
PubMed 40689022
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Thread-embedding and Auricular Acupuncture in the Treatment of Non-specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06682273
- Acronym / sponsor ID
- 273HDDD-GD
- Conditions
- Chronic Non-Specific Low Back Pain
- Keywords
- acupuncture, thread embedding acupuncture, auricular acupuncture, low back pain, traditional medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 12 Nov 2024 (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.
Low back pain (LBP) is a significant global health issue, with cases expected to rise by 36.4% by 2050. Chronic LBP (cLBP), lasting over three months, is mostly non-specific cLBP (cNLBP), posing a challenge for effective management. Common treatments include medication, exercise, and acupuncture.
This study explores the combined use of thread-embedding and auricular acupuncture for treating cNLBP, as combining these methods is thought to enhance effectiveness. Participants with cNLBP will be randomized into four groups to receive either the combination of both treatments, each treatment individually with a sham, or both shams. The study will last eight weeks, with four weeks of intervention and four weeks of follow-up. Treatment outcomes, including pain, disability, medication use, and quality of life, will be evaluated, along with monitoring for adverse effects.
Detailed description
Low back pain (LBP) is a major public health issue worldwide. In 2020, there were over half a billion cases of LBP globally, and by 2050, the total number of LBP cases is expected to increase by 36.4% worldwide. LBP accounts for 7.7% of total Years Lived with Disability, making it the largest contributor to the global disability burden.
When lasting three months or more, LBP is classified as chronic (cLBP). Most cLBP is non-specific cLBP (cNLBP). Managing cNLBP remains challenging. Recommended therapies include short-term medication, manipulation, supervised exercise, cognitive behavioral therapy, and multidisciplinary treatment. According to the Clinical Practice Guideline from the American College of Physicians, clinicians and patients should initially consider non-pharmacologic treatments, including acupuncture as one of the options.
There is evidence regarding the effectiveness of thread-embedding acupuncture (TEA) and auricular acupuncture (AA) in the treatment of cNLBP. TEA uses the principle of selecting points on the body, while AA involves selecting points on the ear. The difference in the point selection principles of these two methods has led clinicians to often combine them in hopes of enhancing treatment efficacy. However, evidence on the effectiveness of combining these two methods in treating cNLBP remains lacking. This study aims to clarify whether the combination of these methods is more effective than using them individually.
Eligible participants with cNLBP, defined as LBP lasting more than three months without any reasonable explanation and determined by a physician to be nonspecific, will be enrolled and subsequently randomized into four groups: receiving the combination of TEA and AA (TEA + AA group), receiving TEA and sham AA (TEA + sham AA group), receiving AA and sham TEA (AA + sham TEA group), and receiving sham TEA and sham AA (Sham both group), with a 1:1:1:1 allocation ratio.
The study will last for eight weeks, with four weeks of intervention and four weeks of follow-up. AA and sham AA will be administered weekly during the four-week intervention (four sessions). TEA and sham TEA will be administered every two weeks during the four-week intervention (two sessions). Data on treatment efficacy will include disability index, pain score, amount of analgesic medication needed, quality of life score, and global improvement. Additionally, adverse effects will be monitored and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TEA + AA | Experimental | Other: Thread-embedding acupuncture, Other: Auricular acupunctureThread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with auricular acupuncture (AA) every week in 4 weeks (4 sessions). |
| TEA + sham AA | Active comparator | Other: Thread-embedding acupuncture, Other: Sham auricular acupunctureThread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions). |
| AA + sham TEA | Active comparator | Other: Auricular acupuncture, Other: Sham thread-embedding acupunctureAuricular acupuncture (AA) every week in 4 weeks (4 sessions). Combined with sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions). |
| Sham both | Sham comparator | Other: Sham thread-embedding acupuncture, Other: Sham auricular acupunctureSham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with low back pain at the outpatient clinic.
- Diagnosed with non-specific low back pain persisting for more than 3 months, without radiation to the legs.
- Pain-NRS score ≥ 4 on a 10-point scale.
- Independent ambulation capability (with or without walking aids).
- Consent to participate in the study.
Key exclusion criteria (11 listed)
- History of prior lumbar spine surgery.
- Known or suspected severe spinal conditions (e.g., cancer, vertebral fracture, spinal infection, or cauda equina syndrome).
- Signs of concurrent involvement of lumbar nerve roots, plexus, sciatic nerve, other leg nerves, or diagnosed polyneuropathy confirmed by electrodiagnosis.
- Presence of systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis.
- Unstable or untreated severe health conditions (such as end-stage renal disease, advanced liver failure, NYHA class IV heart failure).
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 |
|---|---|---|
| Thread-embedding acupunctureThread-embedding acupuncture is performed every week for 4 weeks, using a single Polydioxaone thread inserted into acupoints on the body through the needle. After the thread is inserted, the needle will be immediately withdrawn. | Other | TEA + AA, TEA + sham AA |
| Auricular acupunctureAuricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into therapeutic points on the ear. The patches with the needle will remain in place for one week. | Other | AA + sham TEA, TEA + AA |
| Sham thread-embedding acupunctureSham thread-embedding acupuncture is performed every week for 4 weeks, using the needle without thread inserted into acupoints on the body. After insertion, the needle will be immediately withdrawn, and no thread will be left in the body. | Other | AA + sham TEA, Sham both |
| Sham auricular acupunctureSham auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into non-therapeutic points on the ear. The patches with the needle will remain in place for one week. | Other | Sham both, TEA + sham AA |
Primary outcome
Change in Oswestry Disability Index (ODI) percentage score
Time frame: Week 0, Week 2, Week 4, Week 6, and Week 8
The Oswestry Disability Index (ODI) percentage score evaluates the impact of low back pain on various activities (sleeping, self-care, sex life, social life, and traveling) using six rating options (0 to 5). Participants select the most appropriate response, and the total score is calculated as a percentage of the maximum possible score (50 if all sections are completed). A score of zero indicates no disability, while a score of 100% implies significant disability.
5 secondary outcomes
Change in pain score on the Numeric Rating Scale (NRS)
Time frame: Week 0, Week 2, Week 4, Week 6, and Week 8
Change in the number of paracetamol tablets used
Time frame: Week 2, Week 4, Week 6, and Week 8
Change in the Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS-GH-10) score
Time frame: Week 0, Week 2, Week 4, Week 6, and Week 8
Global improvement rate
Time frame: Week 2, Week 4, Week 6, and Week 8
Proportion of intervention-related adverse events
Time frame: Up to eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 21753728Hunter RF, McDonough SM, Bradbury I, Liddle SD, Walsh DM, Dhamija S, Glasgow P, Gormley G, McCann SM, Park J, Hurley DA, Delitto A, Baxter GD. Exercise and Auricular Acupuncture for Chronic Low-back Pain: A Feasibility Randomized-controlled Trial. Clin J Pain. 2012 Mar-Apr;28(3):259-67. doi: 10.1097/AJP.0b013e3182274018.
- Background: PubMed 30541604Lee HJ, Choi BI, Jun S, Park MS, Oh SJ, Lee JH, Gong HM, Kim JS, Lee YJ, Jung SY, Han CH. Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial. Trials. 2018 Dec 12;19(1):680. doi: 10.1186/s13063-018-3049-x.
- Background: PubMed 11074683Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
- Background: PubMed 20397032Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J. 2010 Sep;19(9):1484-94. doi: 10.1007/s00586-010-1353-6. Epub 2010 Apr 17.
- Background: PubMed 16320034Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
- Derived from this study: PubMed 40689022Pham TL, Le NT, Nguyen TT, Chu H. Should thread-embedding and auricular acupuncture be combined rather than used individually for non-specific chronic low back pain?: A double-blinded, randomized, sham-controlled trial. Integr Med Res. 2025 Sep;14(3):101180. doi: 10.1016/j.imr.2025.101180. Epub 2025 Jun 13.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Thread-embedding acupuncture and Auricular acupuncture in people with Chronic Non-Specific Low Back Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 24 Mar 2025. 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Oswestry Disability Index (ODI) percentage score (time frame: Week 0, Week 2, Week 4, Week 6, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682273, which also lists 6 linked publications.
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 24 Mar 2025.