Clinical Study on the Treatment of Neck and Shoulder Pain by Intensive Multi-acupuncture Method Based on the Principle of "Tendons Disease Pain-point Needling".
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 主要终点
- clinical efficacy evaluation criteria
研究概览
简要总结
In this study, the proposed subjects came from the Traditional Diagnosisand Treatment Center of Zhongshan Hospital of Zhejiang Province.78 patients with neck and shoulder pain who met the criteria were randomly divided into the control group (39 cases) and the experimental group (39 cases) in a ratio of 1:1.The control group used ordinary acupuncture methods,and the experimental group adopted intensive mtlti-acupuncture method for intervention.The treatment was carried out twice a week,with 4 times as a course of treatment,for a total of one couse of treatment.
The data of VAS NDI,Cervical Range of Motion Assessment,and Constant-Murley Score of the two grous were recorded at the baseline period,after the 2nd treatment,after the 4th treatment,and 2 weeks after the end of the treatment for follow-up.All data were statistically analyzed using SPSS27.0 software,and relevant differences were compared after treatment. In order to evaluate the effectiveness of intensive multi-acupuncture method in the treatment of neck and shoulder pain,and to promote the development and clinical application of"pain as adupoint" meridian stabbing method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the above diagnostic criteria for both Chinese and Western medicine;
- •Aged between 18 and 69 years, with no gender restriction; ③ Disease duration of more than 3 months, with no other treatment received within the past month; ④ Voluntarily participate in this study, comply with the physician's arrangements, cooperate with treatment, and sign the Informed Consent Form.
排除标准
- •Patients with severe life-threatening primary diseases such as severe cardiac, hepatic, renal, or hematopoietic system disorders, as well as those with psychiatric conditions;
- •Patients with pre-existing diseases that may affect the diagnosis of this condition, such as spinal cord injury, significant cervical disc herniation or spondylolisthesis, cervical compression fracture, whiplash injury, etc., as well as those complicated by visceral disorders presenting with similar symptoms; ③ Women who are pregnant or breastfeeding, for whom acupuncture treatment is not suitable;
- •Patients with a history of needle phobia, hemophobia, bleeding tendency, or coagulation disorders;
- •Patients with ulcers or suspected infection on the local body surface; ⑥ Patients who have received other treatments within the past two weeks that may potentially affect the observation of the study outcomes; ⑦ Patients with cognitive impairments who are unable to independently complete the relevant scale assessments or do so under the guidance of the researcher.
研究组 & 干预措施
intensive multi-acupuncture method group
Perpendicular or oblique insertion in the occipital region reaching the periosteal attachment of the superior/inferior nuchal lines; after the needle tip contacts the bone surface, perform mild lifting and thrusting to elicit a sour and distending sensation, with a depth ≤ 3 cm. In the posterior neck, insert along the paravertebral region adjacent to the spinous processes from C2 to T2 and the articular processes using a subperiosteal technique, advancing along the spinous processes with the depth controlled within 0.5 cm beneath the bone surface. In the infraspinous fossa of the scapula, insert perpendicularly toward the bone surface; along the scapular medial border, insert obliquely parallel to the ribs. In the anterior shoulder region, insert at the coracoid process area and the intertubercular groove of the humerus at a 45° oblique angle until the needle tip contacts the bone surface.The treatment is performed twice a week for a total of 4 treatments.
干预措施: Acupuncture (Procedure)
normal needling group
The points were selected with reference to the 2006 National Standard of the People's Republic of China(GB/T 12346-2006),"Acupoint Names and Localization".The patients were placed in the prone position, the acupoints were sterilized with 75% alcohol, and the needles were inserted vertically with the conventional needling method, to the extent that there was a sensation of acidity,numbness,heaviness, distension,or radiating to the surroundings, and the needles were left in place for 15 min. The treatments were carried out twice a week for a total of four treatments.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
clinical efficacy evaluation criteria
时间窗: Through study completion, an average of 1 year
It was evaluated according to the efficacy standard of neck and shoulder pain in the Guidelines for Clinical Research of New Chinese Medicines, and the NDI index was used as the benchmark: Efficacy index (N) = \[(pre-treatment score - post-treatment score) ÷ pre-treatment score\] × 100% * cure: the patient does not feel obvious back pain and other discomforts, N ≥ 90% * Effective: Effective: low back pain is significantly relieved, 60% ≤ N \< 90% ③ Effective: lower back pain is relieved, 30%≤N\<60%. ④ Ineffective: the patient's low back pain is not relieved, N\<30%. Total effective rate (%) = \[(number of cured + number of effective + number of effective) ÷ number of cases in each group\] × 100%.
次要结局
- Pain visual analog scale score(VAS)(Through study completion, an average of 1 year)
- Neck Disability Index (NDI) score(Through study completion, an average of 1 year)
- Cervical Range of Motion (CROM) scale(Through study completion, an average of 1 year)
- Constant-Murley Score (CMS) scale(Through study completion, an average of 1 year)
研究者
Yongliang Jiang
Chief Physician
Zhejiang Chinese Medical University