NCT02824887

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

3.3 years

First QC Date

June 5, 2016

Last Update Submit

July 6, 2016

Conditions

Keywords

ElectroacupunctureDeep needlingLumbar disc herniation five pointsLong term effectProspective cohort study

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Exposed group

Long term curative effect of electroacupuncture treatment of lumbar intervertebral disc herniation in exposure group

Other: Electro-acupuncture

control group

Long term efficacy of conventional treatment of lumbar disc herniation in the control group

Other: Conventional treatment of Western Medicine

Interventions

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

Exposed group

Routine non operative treatment of Western Medicine

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Jian Xin, doctor

CONTACT

Li Zhao Qiang, undergraduate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

June 5, 2016

First Posted

July 7, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

July 7, 2016

Record last verified: 2016-07