Deep Needling Protrusion of Lumbar Intervertebral Disc the Five Acupoints

• Conditions: Protrusion of Lumbar Intervertebral Disc
• Interventions: Other: Electro-acupuncture; Other: Conventional treatment of Western Medicine

• Registration Number: NCT02824887
• Lead Sponsor: The Third Affiliated Hospital of Beijing University of Chinese Medicine

Brief 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.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-05
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-06
• Last Update Submitted: 2016-07-06
• Study First Posted: 2016-07-07
• Last Update Posted: 2016-07-07
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 175

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed group	Electro-acupuncture	Long term curative effect of electroacupuncture treatment of lumbar intervertebral disc herniation in exposure group
control group	Conventional treatment of Western Medicine	Long term efficacy of conventional treatment of lumbar disc herniation in the control group

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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