Effectiveness of Diathermy Compared to Dry Needling in the Short-term Management of Subjects With Chronic Low Back Pain: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual analogue scale
研究概览
简要总结
Introduction: Diathermy is a new tool that could help subjects with chronic low back pain (CLBP), with no studies having compared it to other interventions already investigated such as dry needling.
Hypothesis: Diathermy is more effective than dry needling in improving pain intensity in the short term in subjects with CLBP.
Design: randomised controlled trial Methods: We will conduct a convenience sampling, with subjects receiving 2 treatment sessions with diathermy or dry needling, according to allocation. Subjects will be assessed at baseline, 1 week, 1 month and 3 months after treatment for pain intensity, disability, kinesiophobia and catastrophizing. Analysis of variance (ANOVA) and moderation analysis will be performed to evaluate the results, with 95% confidence intervals (CI).
详细描述
A prospective longitudinal experimental randomised controlled trial study will be conducted from August 2022 to March 2023. The study will be conducted in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement,15 and in accordance with the Declaration of Helsinki.
Subjects were randomly assigned to one of the two intervention groups:
Diathermy. Diathermy treatment was applied using the TCaRe Power diathermy instrument (PRIM Physio©), using a capacitive system with an intensity of 50%, with slight variation depending on patient tolerance and 500khz. The therapy will be applied for 10 minutes on each side of the patient's lumbar region, who will be positioned in prone decubitus during the intervention.
The application will be active along with massage techniques. Dry needling. Dry needling is performed with a 4cm needle (APS Dry Needles®) on the most symptomatic side of the patient on palpation. To perform the technique, the patient is positioned in prone position on the couch. The physiotherapist palpates the lateral border of the lumbar iliocostalis muscle and performs the tapping technique in a latero-medial direction parallel to the stretcher.
The technique is performed by applying 12 incisions. After the application of the technique, ischaemic compression shall be performed for 1 minute.
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)
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
- •Age between 18 and 65 years.
- •Chronic non-specific low back pain.
- •Duration of pain of more than 6 weeks.
排除标准
- •Neurological signs or symptoms.
- •Radicular pain.
- •Radiating pain below the knee.
- •Belonephobia.
- •Traumatic processes and/or surgeries in the lumbar region in the last year.
- •Having received physiotherapy treatment in the last 3 months.
- •Systemic diseases such as cancer, rheumatic diseases, neurological diseases.
研究组 & 干预措施
Dry needling
Dry needling is performed with a 4cm needle (APS Dry Needles®) on the most symptomatic side of the patient on palpation. To perform the technique, the patient is positioned in prone position on the couch. The physiotherapist palpates the lateral border of the lumbar iliocostalis muscle and performs the tapping technique in a latero-medial direction parallel to the stretcher.
The technique is performed by applying 12 incisions. After the application of the technique, ischaemic compression shall be performed for 1 minute.
Patients will complete a home exercise program
干预措施: Dry needling (Other)
Diathermy treatment
Diathermy treatment will be applied using the TCaRe Power diathermy instrument (PRIM Physio©), using a capacitive system with an intensity of 50%, with slight variation depending on patient tolerance and 500khz. The therapy will be applied for 10 minutes on each side of the patient's lumbar region, who will be positioned in prone decubitus during the intervention.
Patients will complete a home exercise program
干预措施: Tecartherapy treatment (Other)
结局指标
主要结局
Visual analogue scale
时间窗: Change from baseline at 3 months
The visual analogue scale (VAS) is a 10cm long line where 0 indicates no pain at all and 10 the worst pain imaginable. It is a tool that has shown good reliability values (r = 0.94).
次要结局
- Rolland-Morris questionnaire(Change from baseline at 3 months)
- Tampa Scale for Kinesiophobia 11 (TSK-11)(Change from baseline at 3 months)
- Pressure pain threshold(Change from baseline at 3 months)
- Pain Catastrophism Scale(Change from baseline at 3 months)
研究者
Prof. Dr. Daniel Pecos Martín
Principal Investigator
University of Alcala