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

Primary Purpose

Non-specific Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yanqing Zhitong Ointment Acupoint application
placebo acupoint application
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Longhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
June 17, 2021
Last Updated
August 1, 2022
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05040243
Brief Title
Acupuncture Combined With Yanqing Zhitong Ointment Acupoint Application in Chronic Non-specific Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yanqing Zhitong Ointment Acupoint application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo acupoint application
Intervention Description
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 Measure Information:
Title
Lumbar JOA Scale
Description
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
Secondary Outcome Measure Information:
Title
Lumbar JOA Scale
Description
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
Title
Visual Analog Scoring (VAS)
Description
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
Title
Oswestry Dysfunction Index (ODI)
Description
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
Title
McGill Pain Questionnaire (MPQ)
Description
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
Title
Concise health scale SF-36
Description
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
Title
Tenderness threshold
Description
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
Title
Averaged electromyography, AEMG
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnostic of non-specific low back pain Aage from 18 to 65 Last for at least 12 weeks VAS between 4 and 7 No other treatment in the past 3 months Patients with no partial skin damage No other relevant treatment methods Sign informed consent and informed consent Exclusion Criteria: Pregnant women Suffer from diabetes With skin ulcers or contusion wounds Past history of severe allergy to transdermal preparations Complicated with serious diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JIAN PEI
Phone
18917763082
Email
longhuaacup@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIAN PEI
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Longhua Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PEI JIAN
Phone
18917763082
Email
longhuaacup@aliyun.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25893353
Citation
Maatta 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.
Results Reference
background
PubMed Identifier
25247896
Citation
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.
Results Reference
background
PubMed Identifier
9809733
Citation
NIH Consensus Conference. Acupuncture. JAMA. 1998 Nov 4;280(17):1518-24.
Results Reference
background
PubMed Identifier
22594099
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.
Results Reference
background
PubMed Identifier
28192789
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.
Results Reference
background

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

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