AzTrials
AzTrials

Protrusion of Lumbar Intervertebral DiscNCT02824887

Deep Needling Protrusion of Lumbar Intervertebral Disc the Five Acupoints

An observational study of Protrusion of Lumbar Intervertebral Disc, run by The Third Affiliated Hospital of Beijing University of Chinese Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Protrusion of Lumbar Intervertebral Disc
What is being tested?
Electro-acupuncture and Conventional treatment of Western Medicine
How many people
175 participants
Where
No sites listed yet
Study dates
Jun 2016to Sep 2019
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Meet the criteria for the diagnosis
  • The people whose age are between 18 to 75 years old.
  • Course of no more than 20 years.
  • TCM syndrome type belong to blood stasis, cold dampness syndrome, hot and humid, liver and kidney deficiency license.
  • Pathological classification belongs to unilateral disc herniation or bilateral slipped disc.
  • Signed informed consent will be.

Who cannot join

  • Patients with severe lumbar disc herniation with surgical indications.
  • Complicated by severe developmental spinal stenosis or other severe malformations.
  • Weak constitution, or pregnant women, etc.
  • Suffers from severe heart disease, high blood pressure, liver and kidney disease patients.
  • Skin damage, ulceration or skin disease.
  • Has a bleeding tendency in patients with hematologic diseases.
  • Psychiatric patients.

Trial locations and contacts

No sites are listed yet.

Zhao Jian Xin, doctor contact

13488876286

beijingzhaojianxin@163.com

Li Zhao Qiang, undergraduate contact

15110149610

xiaoqiang1014@sina.com

About this study

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

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.

Read the 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.

Being tested
Electro-acupuncture, Conventional treatment of Western Medicine
Keywords
Electroacupuncture, Deep needling, Lumbar disc herniation five points, Long term effect, Prospective cohort study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electro-acupunctureOther

    Electro acupuncture deep needling protrusion of lumbar intervertebral disc the five acupoints

  • Conventional treatment of Western MedicineOther

    Routine non operative treatment of Western Medicine

Study groups in NCT02824887
Study groupRoleWhat they receive
Exposed groupLong term curative effect of electroacupuncture treatment of lumbar intervertebral disc herniation in exposure group
Receives: Other: Electro-acupuncture
control groupLong term efficacy of conventional treatment of lumbar disc herniation in the control group
Receives: Other: Conventional treatment of Western Medicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. JOA

    Measured: 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

  2. VAS

    Measured: 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

  3. SF-36 quality of life questionnaire

    Measured: Follow-up after treatment,period of about a year

  4. Oswestry functional disorder questionnaire

    Measured: Follow-up after treatment,period of about a year

Secondary outcomes (2)
  1. Patient satisfaction rating scale

    Measured: Follow-up after treatment,period of about a year

  2. Influencing factors questionnaire

    Measured: Follow-up after treatment,period of about a year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionSep 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
175 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02824887
Sponsor's protocol ID
40083459-X
Status last verified
Jul 2016
First submitted
5 Jun 2016
Last updated
7 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Protrusion of Lumbar Intervertebral Disc, run by The Third Affiliated Hospital of Beijing University of Chinese Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhao Jian Xin, doctor (13488876286, beijingzhaojianxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

JOA (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in