Investigating Dry Needling as an Add-on Therapy to Conventional Treatment for Myofascial Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity using Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The proposed clinical study aims to evaluate the effectiveness and safety of adding Dry Needling (DN) to Conventional Treatment (CT) for patients with Myofascial Low Back Pain (MLBP). MLBP is a widespread musculoskeletal condition that causes localized pain, muscle tenderness, and functional limitations, significantly affecting the quality of life and productivity of those affected. Conventional Treatment for MLBP typically combines pharmacotherapy (e.g., NSAIDs, muscle relaxants) and physiotherapy. Dry Needling, an emerging treatment that targets myofascial trigger points with fine needles, has demonstrated promise in relieving pain and improving functional outcomes. However, no study has yet evaluated the combined effects of CT and DN. This randomized, open-label, controlled trial will involve 140 patients (70 per group) and compare the effects of CT alone versus CT combined with DN. The primary objective is to assess the change in pain intensity, while secondary objectives include improvements in pressure pain threshold, range of motion, disability, quality of life, sleep, anxiety, and depression scores.
Safety will also be assessed based on adverse events and vital sign changes. The study will span 24 weeks, with 11 scheduled visits for each participant. Data analysis will be conducted to determine the added benefit of DN as an adjunctive therapy to CT, with the ultimate goal of improving treatment strategies and patient outcomes for MLBP.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject diagnosed with myofascial low back pain, characterized by the presence of trigger points and localized muscle pain/tenderness
- •Subject experiencing myofascial pain symptoms (e.g., muscle pain, tenderness) for at least 3 months
- •Subject has a baseline Numeric Pain Rating Scale (NPRS) score of 4 or higher
- •Subject has stable medical condition that is not expected to significantly deteriorate during the study period in the opinion of the investigator
- •Woman who is postmenopausal for 12 months or less before screening (unless permanently sterilized or using an IUD) must have a negative urine pregnancy test prior to the randomization visit
- •Subject is willing to comply with all aspects of the study protocol, including attending scheduled appointments, completing study assessments and adhering to applicable restrictions
- •Subject has provided informed consent to participate in the study
- •No spine/lumbar surgery in the last 6 months
排除标准
- •Subject presenting sharp, shooting pain radiating to lower limbs (associated with tingling and numbness) along with back pain
- •Subject with active systemic or local infection(s)
- •Subject with bleeding disorder(s) or on anticoagulant medication(s)
- •Subject currently experiencing or with a history of psychiatric condition, cognitive impairment, neurological disorder, or other clinically significant disease or abnormality (such as congestive heart failure, uncontrolled hypertension, myocardial infarction, stroke, uncontrolled coronary artery disease, arrhythmias, uncontrolled diabetes, convulsive disorders etc.) which, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study, or would interfere with their ability to complete the study, or would hinder their ability to understand the study procedures, or would impact their compliance with study assessments or treatment protocols, or would affect pain perception
- •Subject with a history of allergy or hypersensitivity to Etoricoxib, Thiocolchicoside or Diclofenac
- •Subject with a history of alcohol or substance abuse
- •Woman who is pregnant or planning pregnancy during the course of the study
- •Subject who is currently participating in or has participated in any other clinical trial within 3 months prior to screening
研究组 & 干预措施
Conventional Treatment (CT) Group
Also known as Control group. In this group, patients to follow prescribed pharmacotherapy (Fixed Dose Combination "Etoshine MR" tablets BID) daily for first 2 weeks and prescribed physiotherapy daily until Day 168.
干预措施: Fixed Dose Combination "Etoshine MR" tablets (Drug)
Conventional Treatment (CT) Group
Also known as Control group. In this group, patients to follow prescribed pharmacotherapy (Fixed Dose Combination "Etoshine MR" tablets BID) daily for first 2 weeks and prescribed physiotherapy daily until Day 168.
干预措施: Physiotherapy (Other)
Conventional Treatment + Dry Needling (CT+DN) Group
Also known as Add-on group. In this group, in addition to the treatment prescribed for the CT group, patients to also receive 5 dry needling sessions scheduled on Day 0, 3, 7, 10, and 14.
干预措施: Fixed Dose Combination "Etoshine MR" tablets (Drug)
Conventional Treatment + Dry Needling (CT+DN) Group
Also known as Add-on group. In this group, in addition to the treatment prescribed for the CT group, patients to also receive 5 dry needling sessions scheduled on Day 0, 3, 7, 10, and 14.
干预措施: Dry needling (Procedure)
Conventional Treatment + Dry Needling (CT+DN) Group
Also known as Add-on group. In this group, in addition to the treatment prescribed for the CT group, patients to also receive 5 dry needling sessions scheduled on Day 0, 3, 7, 10, and 14.
干预措施: Physiotherapy (Other)
结局指标
主要结局
Change in Pain Intensity using Numeric Pain Rating Scale (NPRS)
时间窗: Screening, Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Numeric Pain Rating Scale (NPRS) is a widely used, validated tool for assessing pain intensity. Patients are asked to rate their pain on a scale from 0 to 10, with 0 representing no pain and 10 representing the worst possible pain. This simple and reliable scale allows patients to quantify their pain level, aiding clinicians in monitoring pain over time and assessing the effectiveness of treatment interventions.
次要结局
- Change in Range of Motion(Day 0, 3, 7, 10, 14, 28, 56, 84, 168)
- Change in Pressure Pain Threshold using Algometer(Day 0, 3, 7, 10, 14, 28, 56, 84, 168)
- Change in Physical Disability using Salen's Disability Rating Index (DRI)(Day 0, 7, 14, 28, 56, 84, 168)
- Change in Pain and Sleep using Pain and Sleep Questionnaire (PSQ-3)(Day 0, 7, 14, 28, 56, 84, 168)
- Change in Quality of Life Scale Score using Burckhardt's Quality of Life Scale (QOLS)(Day 0, 7, 14, 28, 56, 84, 168)
- Change in Patients Impression using Patients' Global Impression of Change (PGI-C) Scale(Day 3, 7, 14, 28, 56, 84, 168)
- Change in Severity of Anxiety and Depression Symptoms using Hospital Anxiety and Depression Scale (HADS)(Day 0, 7, 14, 28, 56, 84, 168)
研究者
Deshbandhu Pachauri
Principal Investigator
Dr. Vishwanath Karad MIT World Peace University