Deep Needling Protrusion of Lumbar Intervertebral Disc the Five Acupoints

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

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.

Study Overview

• Status: Unknown
• Conditions: Protrusion of Lumbar Intervertebral Disc
• Intervention / Treatment: Other: Electro-acupuncture; Other: Conventional treatment of Western Medicine

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 175

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with lumbar disc herniation from department of acupuncture and moxibustion in Third affiliated hospital of Beijing university of Chinese medicine

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed group; Long term curative effect of electroacupuncture treatment of lumbar intervertebral disc herniation in exposure group	Other: Electro-acupuncture; Electro acupuncture deep needling protrusion of lumbar intervertebral disc the five acupoints
control group; Long term efficacy of conventional treatment of lumbar disc herniation in the control group	Other: Conventional treatment of Western Medicine; Routine non operative treatment of Western Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
SF-36 quality of life questionnaire	Follow-up after treatment，period of about a year
Oswestry functional disorder questionnaire	Follow-up after treatment，period of about a year

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction rating scale	Follow-up after treatment，period of about a year
Influencing factors questionnaire	Follow-up after treatment，period of about a year

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Guo Sheng Jun, undergraduate, The Third Affiliated Hospital of Beijing University of Chinese Medicine; Principal Investigator: Wang Yi Li, undergraduate, The Third Affiliated Hospital of Beijing University of Chinese Medicine; Principal Investigator: Li Dan, doctor, The Third Affiliated Hospital of Beijing University of Chinese Medicine; Principal Investigator: Zhou Pei Juan, master, The Third Affiliated Hospital of Beijing University of Chinese Medicine; Principal Investigator: Song Jia Shan, doctor, The Third Affiliated Hospital of Beijing University of Chinese Medicine; Principal Investigator: Liu Ya Ru, master, The Third Affiliated Hospital of Beijing University of Chinese Medicine; Principal Investigator: Song Yu Hui, undergraduate, The Third Affiliated Hospital of Beijing University of Chinese Medicine; Principal Investigator: Li Zhao Qiang, undergraduate, The Third Affiliated Hospital of Beijing University of Chinese Medicine; Principal Investigator: Zhang Hai Xia, undergraduate, The Third Affiliated Hospital of Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: June 5, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (ESTIMATE): July 7, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Electroacupuncture; Prospective cohort study; Deep needling; Lumbar disc herniation five points; Long term effect
• Other Study ID Numbers: 40083459-X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED