The Efficacy of Conventional Physical Therapy Added to Transforaminal Injection in Lumbar Radicular Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity measured by the Numeric Rating Scale (NRS)
研究概览
简要总结
The purpose of this study is to investigate whether adding conventional physical therapy modalities to transforaminal epidural steroid injection (TFESE) provides additional benefits in patients with acute radicular pain due to lumbar disc herniation. While TFESE is a known effective treatment for radicular pain, this research aims to evaluate if physical therapy can further improve pain duration, functional level, disability, and depression scores.
Participants will be divided into two groups based on their ability to attend a physical therapy program:
Group 1: Patients receiving only ultrasound-guided TFESE and a standard home exercise program.
Group 2: Patients receiving ultrasound-guided TFESE combined with 10 sessions of physical therapy (including hot-pack, therapeutic ultrasound, and TENS) and a standard home exercise program.
The study will compare the effects of these treatments on pain intensity, disability, spinal range of motion, and depression levels. Assessments will be conducted at baseline (before injection), 1 hour after injection, and at the 1st and 3rd-month follow-up visits.
详细描述
This study is designed as a single-center, prospective, observational study. Participants are patients diagnosed with lumbar disc herniation (LDH) via physical examination and magnetic resonance imaging (MRI) who present with acute radicular pain symptoms.
Intervention Groups:
Patients are divided into two groups based on their ability to participate in a physical therapy program.
Group 1 (TFESE + PT): Participants receive only ultrasound-guided TFESE.
Group 2 (TFESE Only): Participants receive ultrasound-guided transforaminal epidural steroid injection (TFESE) followed by 10 sessions of conventional physical therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients aged between 18 and 65 years.
- •Diagnosis of lumbar disc herniation confirmed by physical examination and Magnetic Resonance Imaging (MRI) within the last 6 months.
- •Presence of acute radicular pain symptoms lasting more than 3 months.
- •Failure to respond to conservative medical treatments (e.g., medication, rest).
- •Voluntary participation and signed written informed consent.
排除标准
- •History of previous lumbar spinal surgery.
- •Presence of progressive motor deficits or Cauda Equina Syndrome.
- •Pregnancy or breastfeeding.
- •Diagnosis of malignancy, inflammatory rheumatic diseases, or neurodegenerative disorders.
- •Severe obesity (Body Mass Index > 40 kg/m²).
- •Known allergy to injection materials (Lidocaine, Betamethasone).
- •Active local or systemic infection.
- •Presence of bleeding disorders or use of anticoagulants that cannot be safely discontinued.
- •Having received an epidural steroid injection or a clinical physical therapy program within the last 3 months.
研究组 & 干预措施
Group 1
Participants in this group receive only a single-level ultrasound-guided transforaminal epidural steroid injection (TFESE) at the symptomatic level. No clinical physical therapy modalities are applied. All participants in this group are provided with the same standardized home exercise program as Group 2 to maintain a baseline level of activity.
干预措施: Group 2 (Device)
结局指标
主要结局
Change in Pain Intensity measured by the Numeric Rating Scale (NRS)
时间窗: Baseline, 1 hour post-injection, 1 month, and 3 months.
The Numeric Rating Scale (NRS) is an 11-point scale used to assess pain intensity, where 0 represents "no pain" and 10 represents "the worst possible pain." Higher scores indicate greater pain severity.
次要结局
- Change in Functional Disability measured by the Oswestry Disability Index (ODI)(Baseline, 1 month, and 3 months.)
- Change in Depression Levels measured by the Beck Depression Inventory (BDI)(Baseline and 3 months.)
- Change in Neuropathic Pain Presence measured by the DN4 (Douleur Neuropathique 4) Questionnaire(Baseline, 1 month, and 3 months.)
- Change in Spinal Range of Motion (ROM)(Baseline, 1 hour post-injection, 1 month, and 3 months.)
研究者
Nursel Doğanyiğit Kuzan
Specialist Doctor
Ankara Training and Research Hospital