The Effect of Noxipoint™ Therapy Versus Physical Therapy With Transcutaneous Electrical Never Stimulation on Chronic Cervical Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change of Brief Pain Index (BPI) At Its Worst from baseline to 4 weeks
研究概览
简要总结
Chronic cervical pain is a common problem in rehabilitation clinic, but the treatment is time consuming and the effect unsatisfactory. Noxipoint® Therapy, developed by Dr. Charles C. Koo, is a unique electrical stimulation precisely on corresponding "Noxipoints®" of each injured soft tissue, with specific duration and intensity of TENS that induce C-fiber nerve ending sensation. Each application typically last for 2 to 5 minutes. Based on observations of the clinical application, Noxipoint® Therapy appears to relieve chronic neck and shoulder pain significantly with lasting effect, and effectively improves the range of motion. However, large-scale double-blinded, randomized control study on the therapy is not available yet.
The purpose of this study is to compare the effect of Noxipoint® Therapy and physical therapy (including the current TENS application) on patients with chronic neck pain. This study is a prospective stratified randomized control trial. Eighty subjects with chronic cervical pain will be recruited from the Rehabilitation Department or the Physical Therapy Center of National Taiwan University Hospital (NTUH). The qualified subjects will be stratified and randomly allocated into two arms, 40 persons in each:
- Physical Therapy group (PT)
- Noxipoint Therapy group (NT) Subjects in either group will be treated for up to 6 sessions within 3 weeks, about 1.5 hours per session. The treatment will terminate after six sessions or earlier if the patient shows no symptoms.
Subjects will be evaluated before and after the first treatment session and followed up at about 4 weeks, 8 weeks, and 12 weeks after the first treatment.
Outcome measures are (1) the pain scale in the Brief Pain Index, (2) cervical Range of Motion (ROM), (3) Quality of Life (QoL) measured with the Interference of Pain to Life section in the Brief Pain Index (BPI) and (4) ultrasound elastogram. Pain scale, ROM and QoL measures will be taken before and after the first treatment session, and at 4 weeks, 8 weeks and 12 weeks after the first session. Elastogram will be taken before the first treatment, and about four weeks after the first treatment.
Statistics: The effects of PT and NT will be compared based on two-sample hypothesis testing methods. All the estimated P-values are two tailed.
详细描述
Purpose To compare the effect of Noxipoint™ Therapy and physical therapy on subjects with chronic neck pain.
Background There are many interventions for managing the chronic neck pain. The approaches include physical therapy, medication and local corticoid injection, of which physical therapy (PT) is the most prevalent treatment. Transcutaneous electrical nerve stimulation (TENS) is one of the regular treatments of PT and usually used in chronic neck pain as an adjunct therapy. However, the application of TENS, including the location, duration and intensity of stimulation, is only loosely defined and largely decided by physical therapists and thus vary substantially from one application to another.
In spite of the long history of TENS uses, the results of existing studies, including randomized controlled trials (RCTs), have been inconclusive, with some showing benefits of TENS, and others showing none. Moreover, the studies that cite some positive effect of TENS over placebo also found that the effect does not last in the long run. The only conclusion that could be drawn is that TENS sometimes relieves pain in the short term.
Noxipoint™ Therapy, a particular combination of precise location, intensity and duration of electrical stimulation, invented by Charles Koo, the Co-PI of this protocol, may relieve general muscular-skeletal pain and recover the muscle function permanently. Based on observations of clinical application of Noxipoint Therapy on the neck and the shoulder pain, Noxipoint Therapy showed rapid relief and lasting effect several months after the treatment. However, a large-scale randomized control study is not available yet.
The key point of Noxipoint Therapy is that the location of stimulation is the determining factor of the efficacy of the pain treatment. In addition, the intensity, wave pattern and duration of stimulation also play important roles. The patient's compliance with the instruction to avoid stressing the newly recovered muscle/tissue during the "rest period" is also mandatory.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 to 70 years of age
- •Diagnosed as chronic cervical pain syndrome (ICD9: 723.1)
- •Having no less than 6 months of the pain history
- •The pain level >＝ 5 in BPI
- •with trigger points.
排除标准
- •cervical spondylosis
- •local corticoid injection within last two weeks
- •signs of psychosomatic illness
- •unwilling to be randomized
- •pregnant woman
研究组 & 干预措施
Physical therapy arm (PT)
- The TENS device used: FDA K071951
- Patients will be treated with standard physical therapy, including the electrical stimulation. Manual therapy, cold/heat therapy or exercise will be applied at the discretion of the physical therapist for about 60 minutes in each session. Patient education and self-care instructions will be provided. TENS will also be performed in each session for about 30 minutes based on the typical PT guidelines, which will serve both as a part of the standard of care and as a placebo equivalent. It will typically be set at Normal/Modulate mode and 120 Hertz rate.
干预措施: Noxipoint Therapy (NT) (Procedure)
Noxipoint Therapy arm (NT)
Patients will be treated with TENS following Noxipoint Therapy guidelines as highlighted below:
- The TENS device used: FDA K071951
- TENS is calibrated to allow for maximum range in the specifications.
- A pair of electrode pads is placed at the corresponding pair of Noxipoints of the injured muscle/soft tissue, for about 2- 5 minutes during each application.
- The electrical stimulation is set to induce the C-fiber response based on the feedback of the patient.
- If the corresponding pain is not eliminated or reduced after a couple of applications on correct Noxipoints, apply an ice pack for about 10-15 minutes on site before and during the next Noxipoint stimulation.
干预措施: Physical therapy(PT) (Procedure)
结局指标
主要结局
Change of Brief Pain Index (BPI) At Its Worst from baseline to 4 weeks
时间窗: About 4 weeks after the initial treatment
BPI At Its Worst will be assessed before the first treatment and followed up at 4 weeks after the start.
次要结局
- Change of BPI-Average from baseline to the follow-up at 8 weeks(8 weeks after the initial treatment)
- Change of BPI-Right-Now from baseline to the follow-up at 4 weeks(4 weeks after the initial treatment)
- Change of BPI-Right-Now from baseline to the follow-up at 8 weeks(8 weeks after the initial treatment)
- Change of BPI Average from baseline to the follow-up at 4 weeks(4 weeks after the initial treatment)
- Change of BPI-Average from baseline to the follow-up at 12 weeks(12 weeks after the initial treatment)
- Change of QoL(Quality of life) from baseline to the follow-up at 8 weeks(8 weeks after the initial treatment)
- Change of QoL(Quality of life) from baseline to the follow-up at 12 weeks(12 weeks after the initial treatment)
- Change of the normalized Range of motion(ROM) of the neck from baseline to follow-up at 4 weeks(About 4 weeks after the initial session)
- Change of BPI-Right-Now from baseline to the follow-up at 12 weeks(12 weeks after the initial treatment)
- Change of BPI At Its Worst from baseline to 12 weeks(12 weeks after the initial treatment)
- Change of QoL(Quality of life) from baseline to the follow-up at 4 weeks(4 weeks after the initial treatment)
- Change of Brief Pain Index (BPI) At Its Worst from baseline to 8 weeks(About 4 weeks after the initial treatment)