Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

August 10, 2021 updated by: Jian Pei,MD, Shanghai University of Traditional Chinese Medicine

Lu's Acupuncture Protocol for Chronic Neck Pain

Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical basis for the chronic neck pain treatment and evaluation of efficacy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

According to statistics, the incidence of chronic neck pain has significantly increased year by year, particularly tending to younger people, as social competition increase fiercely and the pace of people's daily work and life accelerate. Studying the effective treatment and prevention of chronic neck pain has obvious medical, social and economic significance. Purpose of this trial is to observe and objectively evaluate electroacupuncture (EA) therapy on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical basis for the chronic neck pain treatment and evaluation of efficacy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age of a subject is older than 18 and is younger than 65.
  2. With more than 3 months history of neck pain.
  3. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

  1. With serious protopathy or disease ofcardiovascular,liver,renal,gastrointestinal, hematological systems and so on.
  2. Psychotic，patients with allergic constitution or easily getting infected or bleeding.
  3. Patients have used drugs for preventing neck pain in the last four weeks.
  4. Pregnant women or women in lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: acupuncture
56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral cervical Jiaji (EX-B2),and two trigger points.Bilateral Jianzhongshu (SI15) and Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
Device: acupuncture
56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral Jiaji (EX-B2) of cervical positive reaction plane (taking two pairs). Besides, bilateral Jianzhongshu (SI15) and bilateral Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
Other Names:
  • electroacupuncture
OTHER: comprehensive treatment
Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS(Transcutaneous Electrical Nerve Stimulation) therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
Other: comprehensive treatment
Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
chronic neck pain-the Neck Pain Scale (NPQ)
Time Frame: 20 days(One course)
20 days(One course)
the short-form McGill Pain Questionnaire
Time Frame: 20 days(One course)
20 days(One course)
the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
Time Frame: 20 days(one course)
20 days(one course)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
chronic neck pain-the Neck Pain Scale (NPQ)
Time Frame: one month after a course.
one month after a course.
the short-form McGill Pain Questionnaire
Time Frame: one month after a course
one month after a course
the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
Time Frame: one months after a course
one months after a course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai University of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Longhua Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jian Pei, MD, Longhua Hospital
  • Principal Investigator: Qinhui Fu, MD, Longhua Hospital
  • Principal Investigator: Jia Yan, MM, Shanghai Univercity of TCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 64385700
  • ZYSNXD-CCHPGC-JD-007 (OTHER: Shanghai Municipal Commission of Health and Family Planning)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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