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.
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.
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.
- Conditions
- Protrusion of Lumbar Intervertebral Disc
- 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 group | Role | What they receive |
|---|---|---|
| Exposed group | Long term curative effect of electroacupuncture treatment of lumbar intervertebral disc herniation in exposure group Receives: Other: Electro-acupuncture | |
| control group | Long 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.
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
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
SF-36 quality of life questionnaire
Measured: Follow-up after treatment,period of about a year
Oswestry functional disorder questionnaire
Measured: Follow-up after treatment,period of about a year
Secondary outcomes (2)
Patient satisfaction rating scale
Measured: Follow-up after treatment,period of about a year
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.
- First posted7 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protrusion of Lumbar Intervertebral DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Jian Xin, The Third Affiliated Hospital of Beijing University of Chinese Medicine
- Investigators
- Guo Sheng Jun, undergraduate, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese MedicineWang Yi Li, undergraduate, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese MedicineLi Dan, doctor, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese MedicineZhou Pei Juan, master, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese MedicineSong Jia Shan, doctor, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese MedicineLiu Ya Ru, master, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese MedicineSong Yu Hui, undergraduate, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese MedicineLi Zhao Qiang, undergraduate, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02824887
- Acronym / sponsor ID
- 40083459-X
- Conditions
- Protrusion of Lumbar Intervertebral Disc
- Keywords
- Electroacupuncture, Deep needling, Lumbar disc herniation five points, Long term effect, Prospective cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Other: Electro-acupunctureLong term curative effect of electroacupuncture treatment of lumbar intervertebral disc herniation in exposure group |
| control group | – | Other: Conventional treatment of Western MedicineLong term efficacy of conventional treatment of lumbar disc herniation in the control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-acupunctureElectro acupuncture deep needling protrusion of lumbar intervertebral disc the five acupoints | Other | Exposed group |
| Conventional treatment of Western MedicineRoutine non operative treatment of Western Medicine | Other | control group |
Primary outcome
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
VAS
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
SF-36 quality of life questionnaire
Time frame: Follow-up after treatment,period of about a year
Oswestry functional disorder questionnaire
Time frame: Follow-up after treatment,period of about a year
2 secondary outcomes
Patient satisfaction rating scale
Time frame: Follow-up after treatment,period of about a year
Influencing factors questionnaire
Time frame: Follow-up after treatment,period of about a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo Sheng Jun, undergraduate principal investigator
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Wang Yi Li, undergraduate principal investigator
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Li Dan, doctor principal investigator
The Third Affiliated Hospital of Beijing University of Chinese Medicine
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.