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临床试验/NCT07089472
NCT07089472已完成不适用

Dry Needling Versus Cyriax Technique on Pain, Paraesthesia and Functional Disability in Patients With Chronic Low Back Pain

University of Lahore1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Change in Pain Intensity Measured by Visual Analogue Scale (VAS)

研究概览

简要总结

This study is designed to compare the effectiveness of two physiotherapy techniques-Dry Needling and the Cyriax Technique-in people suffering from chronic low back pain (CLBP) that radiates to the outer thigh, a condition commonly known as meralgia paresthetica.

Meralgia paresthetica occurs when a nerve called the lateral femoral cutaneous nerve (LFCN) gets compressed, leading to pain, numbness, tingling, or burning sensations in the front or side of the thigh. Many patients also experience difficulty in performing daily activities because of these symptoms.

Dry Needling is a modern treatment where fine, sterile needles are inserted into specific muscles to relieve tension and improve nerve function. It is believed to release natural pain-relieving chemicals and reduce inflammation.

On the other hand, the Cyriax Technique is a manual therapy approach involving deep friction massage and gentle mobilizations targeted at the affected nerve area to reduce pressure and pain.

In this study, 80 participants between the ages of 30 and 50 years, who have had low back pain for more than three months and symptoms of nerve entrapment in the thigh, will be randomly divided into two groups. One group will receive Dry Needling therapy, and the other will receive Cyriax treatment. Both groups will also receive standard physiotherapy, including heat therapy, muscle stimulation, and stretching exercises. Treatment will continue for 8 weeks (2 sessions per week).

The aim is to evaluate and compare changes in pain, tingling/numbness (paraesthesia), and daily life functioning using recognized clinical tools such as the Visual Analogue Scale (VAS), Neuropathic Pain Symptom Inventory (NPSI), and the Roland-Morris Disability Questionnaire (RMDQ). Data will be collected at the beginning, and then again after 2, 4, and 8 weeks.

This research will help determine which therapy-Dry Needling or Cyriax-is more effective in treating patients with this type of nerve-related back and thigh pain. The findings may guide physiotherapists and healthcare providers in choosing the most suitable treatment for managing meralgia paresthetica in chronic low back pain.

详细描述

Chronic low back pain (CLBP) with radiating symptoms to the anterolateral thigh, often due to meralgia paresthetica (MP), represents a complex clinical presentation with both musculoskeletal and neuropathic components. MP results from entrapment or irritation of the lateral femoral cutaneous nerve (LFCN), leading to symptoms such as numbness, tingling, burning sensations, and pain in the outer thigh. These symptoms can significantly impair quality of life and physical functioning.

This randomized controlled trial aims to compare two physiotherapeutic interventions-Dry Needling (DN) and the Cyriax Technique-with respect to their impact on pain relief, reduction of paraesthesia, and improvement in functional disability among patients with MP secondary to CLBP.

Participants will be screened based on strict inclusion and exclusion criteria. Eligible participants will be adults aged 30-50 years, diagnosed with CLBP lasting more than three months and exhibiting characteristic symptoms of MP. Exclusion criteria include prior spinal surgery, coagulopathies, serious neurological disorders, or contraindications to dry needling.

After obtaining informed consent, participants will be randomly allocated to either the experimental group (DN) or control group (Cyriax) using computer-generated randomization. Both groups will receive 16 treatment sessions over 8 weeks (2 sessions per week), in addition to standard physiotherapy consisting of heat therapy, electrical muscle stimulation, and targeted exercises.

The dry needling group will receive intramuscular stimulation along the anatomical route of the LFCN, targeting muscles including piriformis, psoas major, iliacus, tensor fasciae latae, vastus lateralis, and sartorius. Aseptic technique using solid filiform needles will be followed, with each needle retained in situ for 15 minutes per session.

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
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with chronic low back pain (time to onset ≥ 3 months) (Erbay, 2002).
  • •Roland Morris Disability Questionnaire score ≥ 4 (Lara-Palomo et al., 2022).
  • •CLBP radiating to Anterolateral thigh with symptoms of numbness tingling (de Ruiter et al., 2023).

排除标准

  • •Patients with sensory and/or coagulation disorders (Lara-Palomo et al., 2022).
  • •A history of spinal surgery, heart complications, concurrent severe central or peripheral nervous system disease (de Ruiter et al., 2023).
  • •Epilepsy, needle phobia, serious pathologies that can be the main cause of chronic low back pain other than meralgia parasthetica (Lara-Palomo et al., 2022).

研究组 & 干预措施

Cyriax Technique Group

Active Comparator

Participants in this group will receive the Cyriax technique (deep transverse friction massage and nerve mobilization) applied along the LFCN pathway near the anterior superior iliac spine (ASIS). Each session will involve 3-5 repetitions of mobilization, with 10-15 second holds. Sessions will be conducted twice a week for 8 weeks (total 16 sessions). Standard physiotherapy (hot pack, EMS, stretching) will be provided alongside.

干预措施: Cyriax Technique (Behavioral)

Dry Needling Group

Experimental

Participants in this group will receive dry needling therapy targeting muscles along the route of the lateral femoral cutaneous nerve (LFCN), including the piriformis, iliacus, tensor fascia latae, vastus lateralis, and sartorius. Each session will involve needle insertion (90 sec-2 mins) with retention for 15 minutes. Sessions will be conducted twice a week for 8 weeks (total 16 sessions). Standard physiotherapy (hot pack, EMS, stretching) will be provided alongside.

干预措施: Dry Needling Therapy (Behavioral)

结局指标

主要结局

Change in Pain Intensity Measured by Visual Analogue Scale (VAS)

时间窗: Baseline, 2nd week, 4th week, and 8th week

Pain intensity will be assessed using the Visual Analogue Scale, a 10-cm line ranging from "no pain" to "worst possible pain." Participants will mark their pain level at each assessment point.

Change in Paraesthesia Measured by Neuropathic Pain Symptom Inventory (NPSI)

时间窗: Baseline, 2nd week, 4th week, and 8th week

Paraesthesia symptoms including tingling, burning, and numbness will be assessed using the NPSI, a self-report tool evaluating intensity and frequency of neuropathic pain symptoms.

Change in Functional Disability Measured by Roland-Morris Disability Questionnaire (RMDQ)

时间窗: Baseline, 2nd week, 4th week, and 8th week

Functional disability will be assessed using the RMDQ, a 24-item self-report questionnaire measuring the impact of low back pain on daily activities. Higher scores indicate greater disability.

次要结局

未报告次要终点

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Faisal Javaid

Student

University of Lahore

研究点 (1)

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