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

Not Applicable

• Conditions: Non-specific Low Back Pain
• Interventions: Other: Yanqing Zhitong Ointment Acupoint application; Other: placebo acupoint application

• Registration Number: NCT05040243
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-06-17
• Study Start: 2021-07-01
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-02
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Yanqing Zhitong Ointment Acupoint application	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.
Control Group	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.

Primary Outcome Measures

Name	Time	Method
Lumbar JOA Scale	Change from baseline JOA at 4weeks	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.

Secondary Outcome Measures

Name	Time	Method
Oswestry Dysfunction Index (ODI)	Change from baseline ODI at 2weeks ,4 weeks and follow up 2weeks	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.
McGill Pain Questionnaire (MPQ)	Change from baseline MPQ at 2weeks ,4 weeks and follow up 2weeks	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.
Lumbar JOA Scale	Change from baseline JOA at 2weeks and follow up 2weeks	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.
Visual Analog Scoring (VAS)	Change from baseline VAS at 2weeks ,4 weeks and follow up 2weeks	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.
Tenderness threshold	Change from baseline tenderness threshold at 2weeks ,4 weeks and follow up 2weeks	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.
Averaged electromyography, AEMG	Change from baseline AEMG at 2weeks ,4 weeks and follow up 2weeks	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).
Concise health scale SF-36	Change from baseline SF-36 at 2weeks ,4 weeks and follow up 2weeks	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.

Trial Locations

Locations (1)

Longhua Hospital; 🇨🇳 Shanghai, China