Effect of Regular Electrotherapy in Patients With Chronic Non-specific Neck Pain and Low-back Pain: a Randomized Controlled Double-blinded Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- change in numeric pain rating scale at 8 weeks compared to baseline
研究概览
简要总结
This randomized controlled double-blinded pilot trial was performed in the Medical University of Vienna, Department of Special Anesthesia and Pain Medicine between 2015 and 2018. Aim of the study was to assess the effect of regular electrotherapy applied on the spinal cord of patients with chronic non-specific neck pain and/or low-back pain. The hypothesis was that subjective feeling of pain, range of motion of the cervical and lumbar region, as well as the activity in daily living improved after weekly electrotherapy sessions for 30 min each.
详细描述
Chronic neck pain and low-back pain are common causes for the decrease in quality of life. Unfortunately, efficacy of medical therapy is limited (Maher et al, 2017), and evidence for the efficacy of transcutaneous electrical nerve stimulation (TENS) therapy for both chronic neck pain (Martimbianco et al, 2019), as well as for chronic low-back pain (Khadilkar et al, 2008) is scarce .
With the aim to assess the effectiveness of regular electrotherapy in chronic pain patients applied via a mat covering the whole spinal cord, and thus allowing deeper current penetration into the tissue compared to conventional TENS, male and female patients with chronic neck pain or low back pain aged 18 years or over were enrolled in this study.
After informed consent, patients were randomly divided in three groups: Group 1 (verum) received right after device calibration suprathreshold electrotherapy on the whole back for 30 min weekly, Group 2 (Control) received device calibration without consequent electrotherapy, Group 3 (Control of Control) just lay on the mat without receiving device calibration nor electrotherapy.
Electrotherapy was applied using a mat covering the whole spinal cord called "StimaWELL". Therefore, all the patients were asked to put off the clothes and lay supine on the mat for 30 min in each session.
Primary outcome was the subjective pain sensation measured with the numeric pain rating scale (NRS). Secondary outcomes were cervical and lumbar range of motion and activities in daily living.
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
- Double (Participant, Investigator)
盲法说明
Randomization was performed using a Computer based randomization program. The physician regulating the electrotherapy device was the only one who was unmasked. The others (physician recruiting the patients, physician investigating the patients at the beginning and in the end of the enrollment, nurses) as well as the patients were blinded. The team was instructed to keep conversations to a minimum required.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic neck pain and/or low back pain longer than 3 month
- •Minimum numeric pain rating scale equal or > 5
排除标准
- •Change in pain medication within 4 weeks prior or during the enrollment (except intake of rescue medication)
- •Additional pain therapies within 4 weeks prior or during the enrollment
- •Pregnancy
- •Previous experience in TENS
- •Cardiac arrythmia/previous cardiac operation/implanted cardiac devices
- •Infection or malignancies affecting the spinal cord/previous spine operation
- •Severe radicular pain with acute paralysis in the extremities
- •Ongoing pension application
研究组 & 干预措施
Therapy
Patients receiving suprathreshold electrotherapy in weekly intervals for a Duration of 30 min each. Device calibration with determination of the individual threshold was performed prior to the application of electrical current.
干预措施: StimaWELL (Device)
Control
Patients receiving device calibration without consequent electrotherapy.
干预措施: StimaWELL (Device)
Control of control
Patients lay on the mat without receiving device calibration nor electrotherapy.
结局指标
主要结局
change in numeric pain rating scale at 8 weeks compared to baseline
时间窗: 8 weeks
Change from baseline subjective pain sensation from 0 (no pain) to 10 (maximum pain) at 8 weeks
次要结局
- change in cervical range of motion at 8 weeks compared to baseline(8 weeks)
- change in lumbar range of motion at 8 weeks compared to baseline(8 weeks)
- Change in activity in daily living influenced by neck pain at 8 weeks compared to baseline(8 weeks)
- Change in activity in daily living influenced by low back pain at 8 weeks compared to baseline(8 weeks)
研究者
Dr. Asami Naka
Sponsor-Investigator
Medical University of Vienna