Cervical SpondylosisNCT04525651
Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument
A study testing Digital Acupuncture Manipulation Therapeutic Instrument and Manual Acupuncture in people with Cervical Spondylosis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The investigators design a randomized, control study to evaluate the therapeutic effect of digital acupuncture instrument in cervical spondylotic radiculopathy patients using the following outcomes: the Visual analogue scale(VAS), neck disability index scale (NDI) and short form 36-item questionnaire (SF-36). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Digital Acupuncture Manipulation Therapeutic Instrument and Manual Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neck pain with the diagnosis of cervical spondylotic radiculopathy;
- Aged between 18-70 years;
- Have not participated in any drug clinical trials within the last month;
- Voluntarily joining this study with informed consents
Who cannot join
- A history of cervical spine trauma or have received cervical spine surgery;
- Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression;
- Cervical spondylosis in urgent need of surgery;
- Pregnant women and lactating women;
- A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
- Anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Jian Pei, Doctor, 00862164385700 ext. 3534, jianpei99@hotmail.com
About this study
The investigators design a randomized, control study to evaluate the therapeutic effect of digital acupuncture instrument in cervical spondylotic radiculopathy patients using the following outcomes: the Visual analogue scale(VAS), neck disability index scale (NDI) and short form 36-item questionnaire (SF-36).
Read the detailed description
Based on the digital acupuncture manipulation therapeutic instrument developed in the previous stage, the acupuncture manipulation acquisition system is used to compare and analyze the analog waves output by the experts' acupuncture manipulation and the manipulative therapeutic apparatus in the system data analysis module, in order to verify the consistency of bioelectric signals of different reinforcing and reducing manipulation of acupuncture and experts' manipulation. The biocompatibility of shock wave was detected by Massachusetts General Hospital Needle sensation scale ((Massachusetts General Hospital Acupuncture Sensation Scale, MASS)). The visual analogue pain score ((Visual analogue scale, VAS)), neck disability index scale ((Neck Disability Index,NDI) and short form 36-item questionnaire (SF-36) were used to evaluate the clinical efficacy and safety of the instrument in the treatment of cervical pain in cervical Spondylotic radiculopathy, and the appropriate syndrome type of the scheme was studied.
- Conditions
- Cervical Spondylosis
- Being tested
- Digital Acupuncture Manipulation Therapeutic Instrument, Manual Acupuncture, Sham Acupuncture
- Keywords
- digital acupuncture manipulation therapeutic instrument, cervical spondylosis
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Acupuncture Manipulation Therapeutic InstrumentDevice
The device is based on the characteristics of traditional acupuncture manipulation of Shanghai School of Traditional Chinese Medicine, and absorbs the information of the techniques of famous experts, modulates the stimulation waveform of the electroacupuncture device by modulating the signal, and realizes the digitization of acupuncture technique information.
Manual AcupunctureOther
Manual acupuncture to acheive de qi.
Sham AcupunctureOther
Sham acupuncture to avoid de qi.
| Study group | Role | What they receive |
|---|---|---|
| Digital Acupuncture Instrument Group | Experimental | The needles will be stimulated manually to achieve de qi (a compositional sensation including soreness, numbness, distention and heaviness) and then paired electrodes from the digital acupuncture instrument will be attached to the needle handles and another two adjunct acupoints by the research assistant. The electric current will be increased until the needles begin to vibrate slightly. Receives: Device: Digital Acupuncture Manipulation Therapeutic Instrument |
| Manual Acupuncture Group | Active comparator | Patients in the MA group will undergo similar procedures as the EA group except that no current will be output from the instrument. Receives: Other: Manual Acupuncture |
| Sham Acupuncture Group | Sham comparator | Patients in the SA group will receive non-invasive acupuncture to avoid de qi. Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue scale（VAS）
A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.
Measured: Change from baseline VAS at 4weeks
Visual Analogue scale（VAS）
A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.
Measured: Change from baseline VAS at 8weeks
Secondary outcomes (2)
Neck Disability Index（NDI）
A scale that helps a patient to quantify neck disability.
Measured: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)
short form 36-item questionnaire, SF-36
a set of 36 questions abstracted from the much longer set of several hundred used in household interview surveys of the U.S. National Health Survey. The SF36 questions are a convenient abbreviation, used for screening purposes to assess the physical function, social function, role limitation, mental health, energy, vitality, pain, and subjective perception of health status. They have been tested and found to be valid and reliable.
Measured: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Jan 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies 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
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Pei, Doctor, Study chair, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525651
- Sponsor's protocol ID
- lhzj20200810
- Status last verified
- Sep 2021
- First submitted
- 11 Aug 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument
- ClinicalTrials.gov ID
- NCT04525651
- Acronym / sponsor ID
- lhzj20200810
- Conditions
- Cervical Spondylosis
- Keywords
- digital acupuncture manipulation therapeutic instrument, cervical spondylosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Aug 2020 (actual)
- 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.
The investigators design a randomized, control study to evaluate the therapeutic effect of digital acupuncture instrument in cervical spondylotic radiculopathy patients using the following outcomes: the Visual analogue scale(VAS), neck disability index scale (NDI) and short form 36-item questionnaire (SF-36).
Detailed description
Based on the digital acupuncture manipulation therapeutic instrument developed in the previous stage, the acupuncture manipulation acquisition system is used to compare and analyze the analog waves output by the experts' acupuncture manipulation and the manipulative therapeutic apparatus in the system data analysis module, in order to verify the consistency of bioelectric signals of different reinforcing and reducing manipulation of acupuncture and experts' manipulation. The biocompatibility of shock wave was detected by Massachusetts General Hospital Needle sensation scale ((Massachusetts General Hospital Acupuncture Sensation Scale, MASS)). The visual analogue pain score ((Visual analogue scale, VAS)), neck disability index scale ((Neck Disability Index,NDI) and short form 36-item questionnaire (SF-36) were used to evaluate the clinical efficacy and safety of the instrument in the treatment of cervical pain in cervical Spondylotic radiculopathy, and the appropriate syndrome type of the scheme was studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Digital Acupuncture Instrument Group | Experimental | Device: Digital Acupuncture Manipulation Therapeutic InstrumentThe needles will be stimulated manually to achieve de qi (a compositional sensation including soreness, numbness, distention and heaviness) and then paired electrodes from the digital acupuncture instrument will be attached to the needle handles and another two adjunct acupoints by the research assistant. The electric current will be increased until the needles begin to vibrate slightly. |
| Manual Acupuncture Group | Active comparator | Other: Manual AcupuncturePatients in the MA group will undergo similar procedures as the EA group except that no current will be output from the instrument. |
| Sham Acupuncture Group | Sham comparator | Other: Sham AcupuncturePatients in the SA group will receive non-invasive acupuncture to avoid de qi. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neck pain with the diagnosis of cervical spondylotic radiculopathy;
- Aged between 18-70 years;
- Have not participated in any drug clinical trials within the last month;
- Voluntarily joining this study with informed consents
Key exclusion criteria (6 listed)
- A history of cervical spine trauma or have received cervical spine surgery;
- Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression;
- Cervical spondylosis in urgent need of surgery;
- Pregnant women and lactating women;
- A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
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 |
|---|---|---|
| Digital Acupuncture Manipulation Therapeutic InstrumentThe device is based on the characteristics of traditional acupuncture manipulation of Shanghai School of Traditional Chinese Medicine, and absorbs the information of the techniques of famous experts, modulates the stimulation waveform of the electroacupuncture device by modulating the signal, and realizes the digitization of acupuncture technique information. | Device | Digital Acupuncture Instrument Group |
| Manual AcupunctureManual acupuncture to acheive de qi. | Other | Manual Acupuncture Group |
| Sham AcupunctureSham acupuncture to avoid de qi. | Other | Sham Acupuncture Group |
Primary outcome
Visual Analogue scale（VAS）
Time frame: Change from baseline VAS at 4weeks
A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.
Visual Analogue scale（VAS）
Time frame: Change from baseline VAS at 8weeks
A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.
2 secondary outcomes
Neck Disability Index（NDI）
Time frame: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)
short form 36-item questionnaire, SF-36
Time frame: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
Related trials for Cervical Spondylosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Recruiting
Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
Cervical Spondylosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
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, Doctor study chair
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Acupuncture Manipulation Therapeutic Instrument and Manual Acupuncture in people with Cervical Spondylosis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 4 inclusion and 6 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jian Pei, Doctor (00862164385700 ext. 3534, longhuaacup@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue scale（VAS） (time frame: Change from baseline VAS at 4weeks). The study lists 2 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 10 Sep 2021.