Deep Needling Protrusion of Lumbar Intervertebral Disc the Five Acupoints

Protrusion of Lumbar Intervertebral Disc Clinical Trial

Official title:

A Prospective Cohort Study of Electroacupuncture Deep Needling Protrusion of Lumbar Intervertebral Disc the Five Acupoints in the Treatment of Lumbar Disc Herniation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02824887
• Other study ID #: 40083459-X
• Status: Not yet recruiting
• Phase: N/A
• First received: June 5, 2016
• Last updated: July 6, 2016
• Start date: June 2016
• Est. completion date: September 2019

Study information

• Verified date: July 2016
• Source: The Third Affiliated Hospital of Beijing University of Chinese Medicine
• Contact: Zhao Jian Xin, doctor
• Phone: 13488876286
• Email: beijingzhaojianxin[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Compare the curative effects of electroacupuncture deep needling difference in efficacy of the conservative treatment for lumbar five point therapy and routine western medicine, to explore the efficacy and superiority, open a new way for the treatment of lumbar disc herniation.Through a comparative analysis of the data on the efficacy of different TCM Syndrome Types in the subgroup of patients with, to explore the effect of Electroacupuncture of deep needling and five lumbar acupoint therapy is most suitable for the TCM syndrome type.Through follow-up, patients in the two groups moment condition and the survival of the state was evaluated, explore the effect of electroacupuncture deep needling the long-term effects of five lumbar acupoint therapy for treatment of lumbar disc herniation and factors that may influence the recurrence of symptoms.

Description:

Beijing and North China area is lumbar protrusion of the intervertebral disc is the most prevalent area, much due to white-collar workers movement amount is small, the long-term bad posture, or do not move for a long time does not accept the ultraviolet radiation due to osteoporosis. The lumbar disc herniation in young people in a year of rapid growth trend, serious illness and severe low back pain even cannot move and accompanied by paralysis of the legs, hair is cool, weakness, intermittent claudication even muscle atrophy and neurological dysfunction, and so on. Some of them have already caused the degeneration of intervertebral disc or the phenomenon of aging. Recent studies show that only 10% - 20% of the lumbar disc herniation patients need surgical treatment, for does not have the surgery patients with, choice of a curative effect, quick effect and side effects of small, simple conservative treatment methods become many lumbar intervertebral disc herniation were urgent needs.Electroacupuncture and deeply needling five lumbar acupoint therapy is the person in charge of the project after more than 20 years of clinical experience put forward the innovation specific therapy is a novel method for the treatment and prognosis of lumbar protrusion of the intervertebral disc to carry out the innovative clinical research applications, both at home and abroad there is no precedent. The project team through a small range of clinical research and literature research have confirmed the efficacy of electro acupuncture treatment of lumbar disc herniation is reliable, but the long-term efficacy of acupuncture therapy has not been carried out. Therefore, combined with the cohort study of conventional medical practice without human intervention, the results of the study more in line with the actual advantages of the design prospective cohort study. Through long-term follow-up, with a large number of clinical evidence of electroacupuncture deep needling five lumbar acupoint therapy for treatment of lumbar disc herniation with conventional western medicine conservative treatment when compared to the differences in efficacy, treatment, recurrence rate, and to explore the long-term effect of lumbar disc herniation recurrence factors and this kind of therapy in the treatment of lumbar disc herniation.This project involved deep needling lumbar five points and long-term follow-up of the key contents and fit the lumbar disc herniation rate high, and recurrent episodes of the characteristics of the course of lingering, represents a concern in modern medical disease curative effect at the same time pay more attention to the development direction of the prognosis of the disease, with good prospects for clinical application. After 1 year, 175 patients visit and follow up the formation of the research results, will be able to EA deep needling lumbar five point therapy to provide high quality clinical evidence, and gradually formed this kind of special treatment as the core characteristics of traditional Chinese medicine treatment pattern, promote the hospital in clinical characteristics and advantages of the party to the development. And in order to attract patients with indications, the amplification of the unit's outpatient volume, to achieve indirect economic benefits. From the social point of view, this study explore drawn about the clinical results and the research process of the patients for rehabilitation guidance, will be of direct benefit to the patient's path choice, for long-term efficacy and prognosis of diseases and lay a good foundation, reduce disease recurrence to help patients to relieve pain, shorten the course of disease, saving the cost of medical treatment. At the same time, a large number of clinical cases of the subject group will be used to establish a database of patients with lumbar disc herniation, which is convenient for the retrospective study in the future. This study through the practice of training training a group with high data acquisition and doctor-patient communication skills and master the characteristics and effective treatment method for the researchers, will also become the support project subject to bear the backbone of the sustainable development.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Meet the criteria for the diagnosis

2. The people whose age are between 18 to 75 years old.

3. Course of no more than 20 years.

4. TCM syndrome type belong to blood stasis, cold dampness syndrome, hot and humid, liver and kidney deficiency license.

5. Pathological classification belongs to unilateral disc herniation or bilateral slipped disc.

6. Signed informed consent will be.

Exclusion Criteria:

1. Patients with severe lumbar disc herniation with surgical indications.

2. Complicated by severe developmental spinal stenosis or other severe malformations.

3. Weak constitution, or pregnant women, etc.

4. Suffers from severe heart disease, high blood pressure, liver and kidney disease patients.

5. Skin damage, ulceration or skin disease.

6. Has a bleeding tendency in patients with hematologic diseases.

7. Psychiatric patients.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Protrusion of Lumbar Intervertebral Disc

Intervention

Other:
• Electro-acupuncture
Electro acupuncture deep needling protrusion of lumbar intervertebral disc the five acupoints
• Conventional treatment of Western Medicine
Routine non operative treatment of Western Medicine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated Hospital of Beijing University of Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	JOA		through study completion, an average of 13 months;before treatment,after the sixth treatment,after 3 months of treatment ,after 6 months of treatment ,after 1 year of treatment	Yes
Primary	VAS		through study completion, an average of 13 months;before treatment,after the sixth treatment,after 3 months of treatment ,after 6 months of treatment ,after 1 year of treatment	Yes
Primary	SF-36 quality of life questionnaire		Follow-up after treatment,period of about a year	Yes
Primary	Oswestry functional disorder questionnaire		Follow-up after treatment,period of about a year	Yes
Secondary	Patient satisfaction rating scale		Follow-up after treatment,period of about a year	Yes
Secondary	Influencing factors questionnaire		Follow-up after treatment,period of about a year	Yes