An interventional study of Yanqing Zhitong Ointment Acupoint application and placebo acupoint application in Non-specific Low Back Pain, sponsored by Shanghai University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Shanghai University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
Shanghai University of Traditional Chinese Medicine is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
On the basis of conventional acupuncture treatment combined with acupoint application of Yanqing Zhitong Ointment. Acupuncture point:Weizhong,Shenshu,Dachangshu,Jaji,Ashi Acupoint application:Pain in the lumbar spine, Mingmen, Yaoyangguan, Shenshu (double), Ashi (6 points in total); Within 3 inches beside the spine on both sides of the waist, Shenshu (double), Dachangshu (double), Ashi (6 points in total); 3 inches away from the sides of the spine on both sides of the waist, Shenshu (double), Zhishi (double), Ashi (6 points in total). Stick to each point 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. Three times a week( Monday, Wednesday, and Friday). Course of treatment: each course lasts for 2 weeks, a total of 2 courses of continuous treatment.
Other: Yanqing Zhitong Ointment 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.
Other: placebo 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.
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.
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.
Time frame: Change from baseline JOA at 4weeks
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.
Time frame: Change from baseline JOA at 2weeks and follow up 2weeks
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.
Time frame: Change from baseline VAS at 2weeks ,4 weeks and follow up 2weeks
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.
Time frame: Change from baseline ODI at 2weeks ,4 weeks and follow up 2weeks
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.
Time frame: Change from baseline MPQ at 2weeks ,4 weeks and follow up 2weeks
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.
Time frame: Change from baseline SF-36 at 2weeks ,4 weeks and follow up 2weeks
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.
Time frame: Change from baseline tenderness threshold at 2weeks ,4 weeks and follow up 2weeks
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).
Time frame: Change from baseline AEMG at 2weeks ,4 weeks and follow up 2weeks
Started Jul 2021 (actual). Primary completion is estimated for Dec 2022, 17 months after the start.
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