Efficacy and Safety of Electro-thumbtack Needle Therapy for Patients With Chronic Neck Pain: a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Proportion of participants with an at least 50% decrease in NRS-NP from baseline.
研究概览
简要总结
This prospective trial will be a single-center, participant-blinded, randomized controlled trial. It is reported in previous studies that both acupuncture and transcutaneous electrical nerve stimulation are effective in reducing neck pain comparing to placebo or exercise. Taking into account the convenience of electro-thumbtack needle therapy shown in clinical practice, this study aims to evaluate the efficacy and safety of electro-thumbtack needle therapy for alleviating chronic neck pain compared with sham electro-thumbtack needle therapy.
详细描述
Chronic neck pain is a commonly experienced symptom that often influences work efficiency and life satisfaction for years. A total of 180 participants suffering mechanical chronic neck pain will be recruited and randomized into either electro-thumbtack needle therapy group or sham electro-thumbtack needle therapy group. All participants will receive the standardized neck exercise instruction at their first treatment session and will be asked to perform the exercise once every day during 4-week treatment. All assessments will be performed by the assessor and the assessment results will be all kept from the acupuncturist. The statistician will be involved in neither assessment nor treatment and will be blinded regarding intervention group code.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with neck pain with headaches or neck pain with movement coordination impairments according to the Orthopaedic Section of the American Physical Therapy Association (APTA);
- •Aaged 18-65 years;
- •History of neck pain for at least 3 months;
- •A score of ≥4 in Numerical Rating Scale for neck pain (NRS-NP) assessing the average neck pain intensity over last 7 days until the day of recruitment.
排除标准
- •Diagnosed with neck pain with mobility deficits or neck pain with radiating pain according to the Orthopaedic Section, APTA;
- •Known specific reason leading to neck pain such as tumor, immune disease, endocrine and metabolic disorders, neurological abnormalities, cervical vertebra fracture, cervical dislocation;
- •Acute neck pain or neck pain with radiating pain or upper limb symptoms;
- •Neck pain with sensory or motor disturbance;
- •Prior cervical spine surgery or congenital abnormalities;
- •Experiencing medical dispute litigation;
- •Have received acupuncture in last 30 days;
- •In need of analgesic, muscle relaxant, hormones, or bearing greater pain from another area;
- •Allergic to metal or adhesive tape, or carrying cardiac pacemaker, or skin damaged at selected acupoints;
- •Disable to communicate or critically ill;
- •Drug or alcohol dependent;
- •Currently or planning to be pregnant.
研究组 & 干预措施
Electro-thumbtack Needle Therapy (ETN) group
Electro-thumbtack needles (0.25×2 mm) will be inserted into acupoints of Dazhui (GV14), bilateral Wangu (GB12), bilateral cervical Jiaji (at C4 and C6 level), two Ashi points and bilateral Houxi (SI3) after sterilization. Then apply the gel electrodes and stimulation devices, turn on the device to produce a proper electric stimulation that the participant can tolerate.
干预措施: Electro-thumbtack Needle Therapy (Procedure)
Sham Electro-thumbtack Needle Therapy (ETN) group
Sham electro-thumbtack needles (0.25×0.2 mm) which are specially produced have blunt tips instead of sharp needle tip. They will be taped on acupoints of Dazhui (GV14), bilateral Wangu (GB12), bilateral cervical Jiaji (at C4 and C6 level), two Ashi points and bilateral Houxi (SI3) after sterilization. Then apply the gel electrodes and stimulation devices, produce a minimal level of electric stimulation for 30 seconds before turning off the device.
干预措施: Sham electro-thumbtack needle therapy (Procedure)
结局指标
主要结局
Proportion of participants with an at least 50% decrease in NRS-NP from baseline.
时间窗: week 4
Rate pain intensity by 11 numbers from 0 (no pain at all) to 10 (worst pain imaginable)
次要结局
- Change of NRS-NP from baseline.(week 4, 16, 28)
- Proportion of participants with an at least 50% decrease in NRS-NP from baseline.(week 16, 28)
- Degree of PGIC.(week 4, 28)
- Proportion of participants with an at least 25% decrease in NPQ from baseline and a "better" or "much better" for global effectiveness rating.(week 4, 16, 28)
- Change of NDI from baseline.(week 4, 16, 28)
- Proportion of participants with an at least 30% decrease in NRS-NP from baseline.(week 4, 16, 28)
- Change of NPQ from baseline.(week 4, 16, 28)
- Proportion of participants with an at least 10-point decrease in NDI from baseline.(week 4, 16, 28)
研究者
Shi Hangyu
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences