MedPath

Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain

Not Applicable
Active, not recruiting
Conditions
Non-specific Low Back Pain
Interventions
Other: Yanqing Zhitong Ointment Acupoint application
Other: Acupuncture
Registration Number
NCT06102291
Lead Sponsor
ZhanYJ
Brief 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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
150
Inclusion Criteria
  1. Diagnosed with non-specific low back pain
  2. Aage from 18 to 65
  3. VAS between 4 and 7
  4. No other treatment in the past 3 months
  5. No other simultaneous relevant treatment
  6. Voluntarily joining this study with informed consents
Exclusion Criteria
  1. Pregnant women
  2. With skin ulcers or contusion wounds
  3. Past history of severe allergy to transdermal preparations
  4. Complicated with serious diseases

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Acupoint application with Yanqing Zhitong OintmentYanqing 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
AcupunctureAcupunctureAcupoint 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
Primary Outcome Measures
NameTimeMethod
McGill pain questionnaireChange 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.

Secondary Outcome Measures
NameTimeMethod
Item Short Form Health Survey (SF-36)Change from baseline to Week 4 and Week 8

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.

McGill pain questionnaireChange from baseline to Week 8 (follow-up)

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.

Oswestry Dysfunction Index (ODI)Change from baseline to Week 4 and Week 8

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.

Tenderness thresholdChange from baseline to Week 4 and Week 8

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.

Trial Locations

Locations (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

🇨🇳

Shanghai, China

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, China
Yijun Zhan
Contact
+8618917699167
jenniferzhan_lhzj@163.com
© Copyright 2025. All Rights Reserved by MedPath