Electroacupuncture Frequency-related Effects on Chronic Low Back Pain in Older Adults: Triple-blind, 12-month Protocol for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Pain intensity - Numerical Rating Scale (NRS)
研究概览
简要总结
Background: Low back pain (LBP) is the most frequent complaint in the clinical practice. Electroacupuncture treatment may be effective, however, the evidence supporting this possibility is still limited, especially in older adults.
Methods: A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific low back pain will be randomly assigned into one of five groups: three electroacupuncture groups (low, high and alternating frequency), a control and a placebo group. The electroacupuncture will be applied twice a week (30 minutes per session) for 5 weeks. The primary clinical outcome will be pain intensity. The secondary outcomes include: quality of pain, physical functioning, perceived overall effect, emotional functionality, patient satisfaction and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed-up after 6 and 12 months to check the effects in the medium and long term.
Discussion: Results of this trial will help clarify the therapeutic effect of different frequencies of electroacupuncture for chronic low back pain in older adults and to determine the most effective electroacupuncture frequency.
详细描述
This study will be a randomized controlled clinical trial with blind evaluators and patients. The study will be conducted at the University of São Paulo (USP), approved by the Research Ethics Committee of the Medical School of USP (authorization No. 2.903.991) and financed with its own resources.
Participants will be recruited through radio ads, social networks and local newspapers. Individuals will be informed about the research proposal and treatment protocol, and those that are interested in participating will be selected according to the inclusion and exclusion criteria.
Patients will be eligible for inclusion if they are over 60 years of age, of either gender, with diagnosis of nonspecific LBP of more than 3 months duration, with or without radiating leg pain, with a minimum pain intensity score of 4 on the 11-point pain numerical rating scale (NRS - Brazilian Portuguese version), that can walk independently (with or without walking devices) and that agree to voluntarily participate in this study and sign the consent form.
Patients will be excluded if they have had previous surgery on the spinal column, have a known or suspected serious spinal pathology (e.g., cancer, vertebral fracture, spinal infection or cauda equina syndrome), a fear of needles, have participated in acupuncture treatment in the previous 30 days, if they are wheelchair users, or if they are unable to sign the consent form.
The protocol of this study is based on standards established under the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).
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)
盲法说明
Prior to the first treatment session, the random allocation sequence will be implemented by a researcher not involved in the patient recruitment or evaluation, and will be generated through the randomization.com program, where each number will match one of five study groups.
After the numbers are generated, they will be placed in sealed, brown envelopes and numbered in series, then given to the acupuncturist. This person will open them according to the numerical sequence, prior to the first session.
Patients will remain blind regarding the category of their allocation throughout the data collection period of the study. Additionally, the evaluators responsible for the data collection and the outcomes assessor will be blinded to the patient allocation. The acupuncturist, being responsible for the interventions, will be the only person not blind to the type of treatment to be performed.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 60 years of age
- •Either gender
- •Diagnosis of nonspecific low back pain of more than 3 months duration, with or without radiating leg pain, with a minimum pain intensity score of 4 on the 11-point pain numerical rating scale (NRS - Brazilian Portuguese version)
- •Walk independently (with or without walking devices)
- •Agree to voluntarily participate in this study and sign the consent form.
排除标准
- •Previous surgery on the spinal column
- •Have a known or suspected serious spinal pathology (e.g., cancer, vertebral fracture, spinal infection or cauda equina syndrome)
- •Fear of needles
- •Have participated in acupuncture treatment in the previous 30 days
- •Wheelchair users.
结局指标
主要结局
Pain intensity - Numerical Rating Scale (NRS)
时间窗: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
Will be measure using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Participants will be asked to rate their average pain levels in the 24 hours prior to the assessment.
Pain intensity - Pressure pain threshold (PPT)
时间窗: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
The PPT will be measured using a pressure algometer (EMG system, Brazil). The assessed region will be marked with a tape measure and a dermatographic pencil. Two points will be marked bilaterally: 5 cm to the right and left of the spinous process of L3 and L5. A control point will be marked on the anterior tibial muscle of the right leg, 5 cm lateral to the tuberosity of the tibia. The circular tip of the algometer will be positioned perpendicular to the participant's skin and gradually pressed until the participant reports that the pressure has become painful and unbearable. Three measurements will be taken at each point with an interval of 1 minute.
次要结局
- Physical functioning - Roland Morris Disability Questionnaire(prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment)
- Physical functioning - Five Times Sit to Stand Test(prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment)
- Perceived overall effect(prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment)
- Psychosocial factors(prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment)
- Emotional functionality - Anxiety(prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment)
- Quality of pain(prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment)
- Emotional functionality - Depression(prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment)
- Patient satisfaction(prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment)