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临床试验/NCT07490366
NCT07490366招募中不适用

Comparison of the Effectiveness of Exercise, Dry Needling and Interfascial Block Treatments in the Treatment of Myofascial Pain Syndrome

Eren Başıbüyük1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
78
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

This study aimed to compare interfascial block therapy with commonly used exercise therapy and conventional invasive dry needling therapy, and to evaluate its effectiveness and superiority. Another objective of this study was to evaluate and compare the short-term and long-term effectiveness of interfascial block, dry needling, and exercise therapies on pain, disability, and quality of life in patients with myofascial pain syndrome. In this respect, our study is important in terms of its contribution to the literature.

详细描述

The study will include patients who present to the Physical Medicine and Rehabilitation outpatient clinic between July 2025 and May 2026 with clinical symptoms consistent with myofascial pain syndrome in the trapezius muscle. Patients referred to our injection clinic (treatment room) for routine myofascial stretching exercises, dry needling, and interfascial block treatments will be included if they meet the inclusion and exclusion criteria specified below. Demographic data such as age, gender, height, and weight will be recorded. At the initial assessment, patients' VAS (Visual Analog Scale), range of motion in the neck, neck disability scale, pressure pain threshold (PPT) measurements with an algometer, central sensitization scale, and Short Form 12 (SF-12) results will be noted. A total of 78 patients will be included in the study and randomly divided into three groups: Group 1 (Exercise group), Group 2 (Exercise + dry needling group), and Group 3 (Exercise + interfascial block group). Randomization will be done using a sealed envelope method. Group 1 will perform cervical ROM and trapezius facial stretching exercises. Group 2 will perform cervical ROM, trapezius facial stretching exercises, and dry needling of the relevant fascia using Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance. Group 3 will perform cervical ROM and trapezius facial stretching exercises, and interfascial application of a mixture of 1 cc of 2% lidocaine and 4 cc of 0.9% saline under ultrasound guidance. Patients will receive a total of 3 treatment sessions, once a week for 3 weeks. All evaluation parameters will be performed before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment. Within-group and between-group differences will be examined statistically.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Myofascial pain in the upper trapezius muscle that has lasted for at least 3 months
  • VAS score of 4 or higher for the current pain
  • Clinically diagnosed with myofascial pain in the trapezius muscle
  • Ages 18 to 55
  • Patients who can follow verbal instructions and have no cognitive deficits

排除标准

  • Having received interventional injections in the neck and shoulder area within the last 3 months
  • Having received physical therapy within the last 3 months
  • Having received regular nonsteroidal anti-inflammatory and myorelaxant treatment within the last month
  • History of surgery on the affected side (neck or shoulder)
  • Chronic inflammatory disease
  • Acute infection
  • History of malignancy
  • Coagulation disorders
  • Pregnancy
  • Liver and kidney pathologies
  • Drug allergy

结局指标

主要结局

Visual Analog Scale

时间窗: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

0-10 scale. Higher scores represent more severe pain.

Cervical Range of Motion

时间窗: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

Will measure flexion/extension, lateral bending, rotation, protraction/retraction in degrees.

Neck Disability Index (NDI)

时间窗: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

The Neck Disability Index (NDI) is a widely used self-report questionnaire that measures functional disability associated with neck pain. It consists of 10 items scored from 0 to 5, covering pain intensity and daily activities. Higher scores indicate greater disability. The NDI is commonly used in clinical practice and research to assess baseline status and monitor treatment outcomes.

Pressure Pain Threshold (PPT)

时间窗: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.

Pressure Pain Threshold (PPT) is a quantitative measure of pain sensitivity assessed using a pressure algometer. It represents the minimum amount of pressure that evokes pain. PPT is widely used in clinical and research settings to evaluate mechanical pain sensitivity, detect hyperalgesia, and monitor treatment effects. Lower PPT values indicate increased pain sensitivity, while higher values reflect reduced sensitivity.

次要结局

  • 12-Item Short Form Survey (SF-12)(before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.)
  • Central Sensitisation Inventory(before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.)

研究者

发起方
Eren Başıbüyük
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eren Başıbüyük

M.D.

Haydarpasa Numune Training and Research Hospital

研究点 (1)

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