Non-specific Low Back PainNCT06102291
Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain
A study testing Yanqing Zhitong Ointment Acupoint application and Acupuncture in people with Non-specific Low Back Pain, run by ZhanYJ at 1 site in China.
Trial summary
This is a non-inferiority randomized controlled trial, recruiting 150 patients with chronic non-specific low back pain. The patients will be randomly assigned either to Yanqing Zhitong Ointment acupoint application group (Treatment Group) or the acupuncture group (Control Group) in a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Yanqing Zhitong Ointment Acupoint application and Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with non-specific low back pain
- Aage from 18 to 65
- VAS between 4 and 7
- No other treatment in the past 3 months
- No other simultaneous relevant treatment
- Voluntarily joining this study with informed consents
Who cannot join
- Pregnant women
- With skin ulcers or contusion wounds
- Past history of severe allergy to transdermal preparations
- Complicated with serious diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, 200032
About this study
Official title: Effect of Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain: a Non-inferiority Randomized Controlled Trial
This is a non-inferiority randomized controlled trial, recruiting 150 patients with chronic non-specific low back pain. The patients will be randomly assigned either to Yanqing Zhitong Ointment acupoint application group (Treatment Group) or the acupuncture group (Control Group) in a 1:1 ratio.
Read the detailed description
This is a non-inferiority randomized controlled trial, 150 patients with chronic non-specific low back pain were randomly assigned to acupoint application group and acupuncture group in a 1:1 ratio. The main acupoints are Ashi points, Shenshu(BL23), Guanyuanshu(BL26). The primary outcome measure is the change of McGill Pain Questionnaire (MPQ) before and after treatment.
- Conditions
- Non-specific Low Back Pain
- Being tested
- Yanqing Zhitong Ointment Acupoint application, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yanqing Zhitong Ointment Acupoint applicationOther
Yanqing Zhitong Ointment is a traditional external preparation of experiential prescription, which is an extract made by water extraction and concentration of Qingfengteng, Corydalis yanhusuo, Interleukin, Kansui, Asarum, etc. Clinical studies in the past ten years have preliminarily shown that it has the effects of warming meridians, promoting blood circulation, dredging collaterals and relieving pain, and has a definite effect.
AcupunctureOther
The main acupoints are Ashi points, Shenshu (BL23), Guanyuanshu (BL26). There are three sessions per week with each session lasting for 20 min. There will be 4 weeks of treatment for each participant in total.
| Study group | Role | What they receive |
|---|---|---|
| Acupoint application with Yanqing Zhitong Ointment | Experimental | Acupoint selection: Ashi points, Shenshu (BL23), Guanyuanshu (BL26) Operation: Stick to each acupoint for about 4 hours. If there is a burning sensation or obvious itching or other discomfort on the part after application, it can be removed in advance.
Treatment Duration: Three times a week( Monday, Wednesday, and Friday), for four weeks Receives: Other: Yanqing Zhitong Ointment Acupoint application |
| Acupuncture | Active comparator | Acupoint selection: Ashi points, Shenshu (BL23), Guanyuanshu (BL26) Operation: Disposable stainless steel needles (0.25mm×25mm) are used. The needles are retained for 20 mins afte Deqi.
Treatment Duration: Three times a week( Monday, Wednesday, and Friday), for four weeks Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill pain questionnaire
MPQ is a multi-factor pain score scale, which establishes a three-dimensional structure of the nature of pain. MPQ has a higher evaluation dimension and can evaluate the multi-dimensional factors of pain. The higher the score, the more severe the pain.
Measured: Change from baseline to Week 4
Secondary outcomes (4)
McGill pain questionnaire
MPQ is a multi-factor pain score scale, which establishes a three-dimensional structure of the nature of pain. MPQ has a higher evaluation dimension and can evaluate the multi-dimensional factors of pain. The higher the score, the more severe the pain.
Measured: Change from baseline to Week 8 (follow-up)
Oswestry Dysfunction Index (ODI)
ODI is a self-evaluation scale for dysfunction of patients with low back pain. It consists of 10 aspects including pain degree, personal living ability (washing, dressing), lifting, walking, sitting, standing, sleep influence, sex life, social activities and travel. Each aspect covers 6 options, with points ranging from 0 to 5 points. The lowest score indicates no abnormal dysfunction, and the highest score indicates severe dysfunction. The corresponding candidate content scores are added up in turn according to the scores, and the percentage of the total score in the highest score (50 points) of all content is obtained, which is called the Oswe-stry dysfunction index.
Measured: Change from baseline to Week 4 and Week 8
Item Short Form Health Survey (SF-36)
SF-36 is currently one of the most widely used universal health-related quality of life measurement tools in the world. SF-36 covers 8 dimensions for assessing health-related quality of life and a total of 36 content items. Each dimension includes: physical function (PF), role physical (RP), bodily pain (BP), General health (GH), vitality (VT), social function (SF), role-emotional (RE) and mental health (MH). SF-36 first calculates the original scores of the eight dimensions, and then obtains the final score after corresponding conversion. The final score is 0-100 points. The higher the final score, the better the health of the testee.
Measured: Change from baseline to Week 4 and Week 8
Tenderness threshold
Use the digital pressure pain meter to measure the pressure pain threshold of soft tissues and muscles, and conduct an objective and quantitative assessment of pain. It is used for auxiliary diagnosis and scientific research of pain in muscles and tendons.
Measured: Change from baseline to Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jul 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZhanYJ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ZhanYJ, Shanghai University of Traditional Chinese Medicine
- Investigators
- Yijun Zhan, Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102291
- Sponsor's protocol ID
- YD202218
- Status last verified
- May 2025
- First submitted
- 22 Oct 2023
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
PubMed 28192789Wen BL, Liu BY, Jin P, Wang XF, Xiang XX, Liu XF, Hu JQ, Lu F, He LY, Zhu WZ, Fang YG, Wang Y. Clinical research of acupoint application for "treatment of winter disease in summer" used to prevent and treat bronchial asthma in children. J Tradit Chin Med. 2012 Mar;32(1):31-9.
PubMed 22594099
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06102291
- Acronym / sponsor ID
- YD202218
- Conditions
- Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ZhanYJUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Oct 2023 (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.
This is a non-inferiority randomized controlled trial, recruiting 150 patients with chronic non-specific low back pain. The patients will be randomly assigned either to Yanqing Zhitong Ointment acupoint application group (Treatment Group) or the acupuncture group (Control Group) in a 1:1 ratio.
Detailed description
This is a non-inferiority randomized controlled trial, 150 patients with chronic non-specific low back pain were randomly assigned to acupoint application group and acupuncture group in a 1:1 ratio. The main acupoints are Ashi points, Shenshu(BL23), Guanyuanshu(BL26). The primary outcome measure is the change of McGill Pain Questionnaire (MPQ) before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupoint application with Yanqing Zhitong Ointment | Experimental | Other: Yanqing Zhitong Ointment Acupoint applicationAcupoint selection: Ashi points, Shenshu (BL23), Guanyuanshu (BL26) Operation: Stick to each acupoint for about 4 hours. If there is a burning sensation or obvious itching or other discomfort on the part after application, it can be removed in advance. Treatment Duration: Three times a week( Monday, Wednesday, and Friday), for four weeks |
| Acupuncture | Active comparator | Other: AcupunctureAcupoint selection: Ashi points, Shenshu (BL23), Guanyuanshu (BL26) Operation: Disposable stainless steel needles (0.25mm×25mm) are used. The needles are retained for 20 mins afte Deqi. Treatment Duration: Three times a week( Monday, Wednesday, and Friday), for four weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with non-specific low back pain
- Aage from 18 to 65
- VAS between 4 and 7
- No other treatment in the past 3 months
- No other simultaneous relevant treatment
Key exclusion criteria (4 listed)
- Pregnant women
- With skin ulcers or contusion wounds
- Past history of severe allergy to transdermal preparations
- Complicated with serious diseases
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 |
|---|---|---|
| Yanqing Zhitong Ointment Acupoint applicationYanqing Zhitong Ointment is a traditional external preparation of experiential prescription, which is an extract made by water extraction and concentration of Qingfengteng, Corydalis yanhusuo, Interleukin, Kansui, Asarum, etc. Clinical studies in the past ten years have preliminarily shown that it has the effects of warming meridians, promoting blood circulation, dredging collaterals and relieving pain, and has a definite effect. | Other | Acupoint application with Yanqing Zhitong Ointment |
| AcupunctureThe main acupoints are Ashi points, Shenshu (BL23), Guanyuanshu (BL26). There are three sessions per week with each session lasting for 20 min. There will be 4 weeks of treatment for each participant in total. | Other | Acupuncture |
Primary outcome
McGill pain questionnaire
Time frame: Change from baseline to Week 4
MPQ is a multi-factor pain score scale, which establishes a three-dimensional structure of the nature of pain. MPQ has a higher evaluation dimension and can evaluate the multi-dimensional factors of pain. The higher the score, the more severe the pain.
4 secondary outcomes
McGill pain questionnaire
Time frame: Change from baseline to Week 8 (follow-up)
Oswestry Dysfunction Index (ODI)
Time frame: Change from baseline to Week 4 and Week 8
Item Short Form Health Survey (SF-36)
Time frame: Change from baseline to Week 4 and Week 8
Tenderness threshold
Time frame: Change from baseline to Week 4 and Week 8
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 21 May 2025.
- Background: PubMed 28192789Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
- Background: PubMed 22594099Wen BL, Liu BY, Jin P, Wang XF, Xiang XX, Liu XF, Hu JQ, Lu F, He LY, Zhu WZ, Fang YG, Wang Y. Clinical research of acupoint application for "treatment of winter disease in summer" used to prevent and treat bronchial asthma in children. J Tradit Chin Med. 2012 Mar;32(1):31-9.
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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.
Yijun Zhan principal investigator
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yanqing Zhitong Ointment Acupoint application and Acupuncture in people with Non-specific Low Back Pain, run by ZhanYJ at 1 site in China.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 May 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 China. 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. 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?
McGill pain questionnaire (time frame: Change from baseline to Week 4). 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 NCT06102291, which also lists 2 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 21 May 2025.