Clinical trial NCT04525651: Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument
Official title: Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spondylosis
Keywords: digital acupuncture manipulation therapeutic instrument
cervical spondylosis
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

1. Neck pain with the diagnosis of cervical spondylotic radiculopathy;
2. Aged between 18-70 years;
3. Have not participated in any drug clinical trials within the last month;
4. Voluntarily joining this study with informed consents

Exclusion Criteria:

1. A history of cervical spine trauma or have received cervical spine surgery;
2. Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression;
3. Cervical spondylosis in urgent need of surgery;
4. Pregnant women and lactating women;
5. A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
6. Anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks

Primary outcomes:
measure: Visual Analogue scale（VAS）
timeFrame: Change from baseline VAS at 4weeks
measure: Visual Analogue scale（VAS）
timeFrame: Change from baseline VAS at 8weeks
Secondary outcomes:
measure: Neck Disability Index（NDI）
timeFrame: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)
measure: short form 36-item questionnaire, SF-36
timeFrame: Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: LongHua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jian Pei, Doctor
role: STUDY_CHAIR
References: