Acupuncture Combined With Yanqing Zhitong Ointment Acupoint Application in Chronic Non-specific Low Back Pain

Non-specific Low Back Pain Clinical Trial

Official title:

A Randomized Controlled Double-blind Study of Acupuncture Combined With Yanqing Zhitong Ointment Acupoint Application in the Treatment of Chronic Non-specific Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040243
• Other study ID #: ZYCCCX-1006
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2022
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: JIAN PEI
• Phone: 18917763082
• Email: longhuaacup[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Carry out a randomized controlled double-blind study, the acupuncture combined with placebo application group was compared with the acupuncture combined with Yanqing Zhitong ointment acupoint application group, 86 patients with chronic non-specific low back pain were included.

Description:

Treatment group(acupuncture combined with Yanqing Zhitong ointment acupoint sticking) Acupoints for manual acupuncture:Weizhong(BL40), Shenshu(BL23) ,Dachangshu(BL25) ,Geshu(BL17) ,Kunlun(BL60) ,Ashi point Acupoints for sticking:According to the location of pain, we select acupuncture points along the meridian

Controal group(acupuncture combined with placebo application) Interventions are same as Treatment Group.

Both groups were treated 3 times a week for 4 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diagnostic of non-specific low back pain

2. Aage from 18 to 65

3. Last for at least 12 weeks

4. VAS between 4 and 7

5. No other treatment in the past 3 months

6. Patients with no partial skin damage

7. No other relevant treatment methods

8. Sign informed consent and informed consent

Exclusion Criteria:

1. Pregnant women

2. Suffer from diabetes

3. With skin ulcers or contusion wounds

4. Past history of severe allergy to transdermal preparations

5. Complicated with serious diseases

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Low Back Pain

Intervention

Other:
• Yanqing Zhitong Ointment Acupoint application
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.
• placebo acupoint application
The control group was combined with placebo acupoint application on the basis of conventional acupuncture treatment. Placebo patch: colored and drug-free patch (composition: petrolatum, food coloring) Acupuncture, application of acupuncture points and treatment course were the same as those in the treatment group.

Locations

Country	Name	City	State
China	Longhua Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (5)

Garcia JB, Hernandez-Castro JJ, Nunez RG, Pazos MA, Aguirre JO, Jreige A, Delgado W, Serpentegui M, Berenguel M, Cantemir C. Prevalence of low back pain in Latin America: a systematic literature review. Pain Physician. 2014 Sep-Oct;17(5):379-91. Review. — View Citation

Määttä JH, Wadge S, MacGregor A, Karppinen J, Williams FM. ISSLS Prize Winner: Vertebral Endplate (Modic) Change is an Independent Risk Factor for Episodes of Severe and Disabling Low Back Pain. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1187-93. doi: 10.1097/BRS.0000000000000937. — View Citation

NIH Consensus Conference. Acupuncture. JAMA. 1998 Nov 4;280(17):1518-24. Review. — View Citation

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. — View Citation

Wen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar JOA Scale	The JOA scale for low back pain consists of the patient's subjective symptoms (0-9 points), clinical signs (0-6 points), daily activity limitation (0-24 points) and bladder function (normal 0 points, slight loss of control-3 points, severe loss of control) -6 points) Four parts, a total score of 29 points. The total score reflects the symptoms and dysfunction of low back pain, and the score indicates the severity of the dysfunction.	Change from baseline JOA at 4weeks
Secondary	Lumbar JOA Scale	The JOA scale for low back pain consists of the patient's subjective symptoms (0-9 points), clinical signs (0-6 points), daily activity limitation (0-24 points) and bladder function (normal 0 points, slight loss of control-3 points, severe loss of control) -6 points) Four parts, a total score of 29 points. The total score reflects the symptoms and dysfunction of low back pain, and the score indicates the severity of the dysfunction.	Change from baseline JOA at 2weeks and follow up 2weeks
Secondary	Visual Analog Scoring (VAS)	VAS is a pain scoring scale that is currently widely used in clinical practice. The scale uses a line segment or ruler with a length of 10 cm, and the subject makes corresponding marks on the line segment according to the subjective pain intensity.	Change from baseline VAS at 2weeks ,4 weeks and follow up 2weeks
Secondary	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.	Change from baseline ODI at 2weeks ,4 weeks and follow up 2weeks
Secondary	McGill Pain Questionnaire (MPQ)	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.	Change from baseline MPQ at 2weeks ,4 weeks and follow up 2weeks
Secondary	Concise health scale 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.	Change from baseline SF-36 at 2weeks ,4 weeks and follow up 2weeks
Secondary	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.	Change from baseline tenderness threshold at 2weeks ,4 weeks and follow up 2weeks
Secondary	Averaged electromyography, AEMG	Surface electromyography (sEMG) is the bioelectric change of neuromuscular activity recorded from the surface of the muscle through electrodes, which can objectively reflect the activity level and functional state of the muscle. The electromyographic biofeedback meter was used to measure the surface electromyographic signals of the paraspinal muscles on both sides during the lumbar flexion and extension exercise in the standing position, and calculate the average electromyographic value (AEMG).	Change from baseline AEMG at 2weeks ,4 weeks and follow up 2weeks