Effectiveness of Dry Needling on Pain, Functional Disability, Postural Control and Pain Pressure Threshold in Patients With Chronic Nonspecific Low Back Pain: A Double-Blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain level
研究概览
简要总结
Low back pain is a major health problem that affects psychosocial, economical, functional and physical aspects of the patients' life. The aim of this study will be to investigate the effectiveness of dry needling on pain, functional disability, postural control and pain pressure threshold in patients with chronic nonspecific low back pain using a randomized controlled trial design.
Patients with chronic nonspecific low back pain will be randomly divided into two groups: Experimental group (dry needling and routine physical therapy) and control group (sham dry needling and routine physical therapy). Primary outcomes will be pain intensity and functional disability. Postural control and pain pressure threshold will be considered as secondary outcomes.
详细描述
Low back pain is a major health problem that affects psychosocial, economical, functional and physical aspects of the patients' life. Since patients with chronic low back pain have impaired postural control and this impairment can cause chronicity and recurrence of low back pain, it is important to evaluate the effectiveness of interventions on postural control in patients with low back pain. Previous studies have shown the effectiveness of dry needling on pain, functional disability and pain sensitivity in patients with low back pain. The effectiveness of dry needling on postural control is not fully known.
The aim of this study will be to investigate the effectiveness of dry needling on pain, functional disability, postural control and pain pressure threshold in patients with chronic nonspecific low back pain.
This study will be a double-blind randomized controlled trial. Forty patients with chronic nonspecific low back pain will be randomly divided into two groups: Experimental group (dry needling and routine physical therapy) and control group (sham dry needling and routine physical therapy). Primary outcomes will be pain intensity and functional disability. Postural control and pain pressure threshold will be considered as secondary outcomes. Outcomes will be assessed before and one week after the intervention.
All of the participants will be identified and recruited by posters and word-of-mouth from the university and the surrounding local communities. Eligible participants will be explained about the purpose and the examination involved in this investigation, and all eligible participants will sign a written informed consent before entering the study.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age between 18 to 45 years.
- •Moderate pain at rest (between 30 and 60 in NPRS).
- •Patients with trigger points in the lumbar multifidus muscle.
- •Patients have the ability to speak and read Persian.
排除标准
- •Currently taking anticoagulant medications
- •Specific low back pain (Neurogenic low back pain, Spinal stenosis, cauda equina syndrome, spondylolisthesis, and Presence of any signs or symptoms of non-musculoskeletal pathology e.g. cancer, infection and fracture in low back and lower extremities based on paraclinical findings)
- •Prior surgery to the lumbosacral spine
- •Inability to obtain prone lying
- •Severe malalignments in the cervical, thoracic, lumbar or pelvic region and the lower limbs
- •History of uncorrected vision impairment, vestibular, hearing or cognitive impairments
- •Leg length discrepancy which disturbs balance
- •Systemic diseases, such as diabetes, fibromyalgia, rheumatoid arthritis, degenerative diseases and other rheumatoid diseases
- •Needle phobia
- •Sacroiliac pain as identified with six clinical tests: compression, distraction, sacral thrust, thigh thrust, Gaenslen's and FABER's
研究组 & 干预措施
Experimental group
The experimental group will comprise 20 participants with chronic non-specific low back pain. The treatment will include dry needling of the lumbar multifidus muscle and routine physical therapy. The needles will be inserted to obtain local twitch response, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes. Routine physical therapy will include low level laser therapy and motor control training. The treatment will last 3 weeks, 6 sessions, twice a week.
干预措施: dry needling (Other)
Control group
The control group will comprise 20 participants with chronic non-specific low back pain. The treatment will include "sham" dry needling of the lumbar multifidus muscle and routine physical therapy. The sham dry needling method consists of the insertion of the needles subcutaneously and no local twitch response will be obtained. The needles will be left in the place for 20 minutes. Routine physical therapy will include low level laser therapy and motor control training. The treatment will last 3 weeks, 6 sessions, twice a week.
干预措施: sham (placebo) dry needling (Other)
结局指标
主要结局
Pain level
时间窗: before intervention (baseline) and one week after intervention
The 0-100 Numeric Pain Rating Scale (NPRS) will be used to evaluate changing in level of pain from the baseline to one week after the intervention. Zero indicates no pain and 100 indicates maximum pain that the patient experiences. The NPRS has the responsiveness to measure the level of pain in people with low back pain.
Functional disability
时间窗: before intervention (baseline) and one week after intervention
The Persian version of The Oswestry Disability Index will be used to evaluate changing in functional disability from the baseline to one week after intervention. This questionnaire includes 10 activities of daily living and a total score of 100. A score below 25 indicates the lowest level of disability, 25 to 50 moderate disability, 50 to 75 severe disability, and 75 to 100 acute disability. The validity and the reliability of the Persian version of this questionnaire has been shown in the previous studies.
次要结局
- Pain Pressure Threshold(before intervention (baseline) and one week after intervention)
- Postural control(before intervention (baseline) and one week after intervention)