Neck PainsNCT01674387
Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain
A study testing acupuncture and comprehensive treatment in people with Neck Pains, run by Shanghai University of Traditional Chinese Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pains
- What is being tested?
- acupuncture and comprehensive treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of a subject is older than 18 and is younger than 65.
- With more than 3 months history of neck pain.
- Informed consent is signed by a subject or his lineal relation.
Who cannot join
- With serious protopathy or disease ofcardiovascular,liver,renal,gastrointestinal, hematological systems and so on.
- Psychotic，patients with allergic constitution or easily getting infected or bleeding.
- Patients have used drugs for preventing neck pain in the last four weeks.
- Pregnant women or women in lactation.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pains
- Being tested
- acupuncture, comprehensive treatment
- Keywords
- electroacupuncture therapy, neck pain, McGill Pain Questionnaire, Acupuncture Therapy, Electroacupuncture, Meridians
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Also called electroacupuncture
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.
comprehensive treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | 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. Receives: Device: acupuncture |
| comprehensive treatment | Other | 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. Receives: Other: comprehensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic neck pain-the Neck Pain Scale (NPQ)
Measured: 20 days(One course)
the short-form McGill Pain Questionnaire
Measured: 20 days(One course)
the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
Measured: 20 days(one course)
Secondary outcomes (3)
chronic neck pain-the Neck Pain Scale (NPQ)
Measured: one month after a course.
the short-form McGill Pain Questionnaire
Measured: one month after a course
the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
Measured: one months after a course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital
- Responsible party
- Principal investigator, Jian Pei,MD, Shanghai University of Traditional Chinese Medicine
- Investigators
- Jian Pei, MD, Study director, Longhua HospitalQinhui Fu, MD, Principal investigator, Longhua HospitalJia Yan, MM, Principal investigator, Shanghai Univercity of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674387
- Sponsor's protocol ID
- 64385700
- Other IDs
- ZYSNXD-CCHPGC-JD-007
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2012
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lu's Acupuncture Protocol for Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT01674387
- Acronym / sponsor ID
- 64385700
- Conditions
- Neck Pains
- Keywords
- electroacupuncture therapy, neck pain, McGill Pain Questionnaire, Acupuncture Therapy, Electroacupuncture, Meridians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Longhua Hospital
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Aug 2012 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Device: acupuncture56 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. |
| comprehensive treatment | Other | Other: comprehensive treatmentOther 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of a subject is older than 18 and is younger than 65.
- With more than 3 months history of neck pain.
- Informed consent is signed by a subject or his lineal relation.
Key exclusion criteria (4 listed)
- With serious protopathy or disease ofcardiovascular,liver,renal,gastrointestinal, hematological systems and so on.
- Psychotic，patients with allergic constitution or easily getting infected or bleeding.
- Patients have used drugs for preventing neck pain in the last four weeks.
- Pregnant women or women in lactation.
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 |
|---|---|---|
| acupunctureAlso: electroacupuncture56 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. | Device | acupuncture |
| comprehensive treatmentOther 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. | Other | comprehensive treatment |
Primary outcome
chronic neck pain-the Neck Pain Scale (NPQ)
Time frame: 20 days(One course)
the short-form McGill Pain Questionnaire
Time frame: 20 days(One course)
the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
Time frame: 20 days(one course)
3 secondary outcomes
chronic neck pain-the Neck Pain Scale (NPQ)
Time frame: one month after a course.
the short-form McGill Pain Questionnaire
Time frame: one month after a course
the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
Time frame: one months after a course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
Related trials for Neck Pains
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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.
Jian Pei, MD study director
Longhua Hospital
Qinhui Fu, MD principal investigator
Longhua Hospital
Jia Yan, MM principal investigator
Shanghai Univercity of TCM
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and comprehensive treatment in people with Neck Pains, run by Shanghai University of Traditional 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 11 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic neck pain-the Neck Pain Scale (NPQ) (time frame: 20 days(One course)). The study lists 3 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 11 Aug 2021.