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临床试验/NCT04941118
NCT04941118Unknown4 期

Evaluation of the Effect of Dextrose Prolotherapy on Pain and Function in Women With Myofascial Pain Syndrome

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

Myofascial pain syndrome is characterized by the presence of hypersensitive points called trigger points that cause pain, tenderness, spasm, stiffness, limitation of movement, weakness, taut band within the muscle, and pain reflected by pressing in a muscle group or a single muscle.

Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces.

In this study, it was aimed to examine the effect of prolotherapy application on pain, neck range of motion and neck disability in women with myofascial pain syndrome.

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 (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 60 women aged 20-50 years with a diagnosis of myofascial pain syndrome

排除标准

  • Cervical radiculopathy, cervical degeneration, neck surgery or trauma in the last year, injection history for myofascial pain syndrome in the last 6 months, cognitive impairment and fibromyalgia, rheumatoid arthritis, hypothyroidism, diabetes mellitus

研究组 & 干预措施

Control group

Sham Comparator

Only saline and local anesthetic (lidocaine)

干预措施: Local anesthetic and saline injection to the myofascial trigger point (Drug)

Dextrose prolotherapy group

Active Comparator

Dextrose, saline and local anesthetic (lidocaine)

干预措施: Injection of dextrose, local anesthetic and saline to the myofascial trigger point (Drug)

结局指标

主要结局

Visual Analog Scale

时间窗: First month post-treatment

0-10 cm visual scale (0: no pain, 10: most severe pain)

Neck Disability Index

时间窗: First month post-treatment

It measures the functional state of the neck by scoring between 0-5 points according to the severity of pain, consisting of 20 questions.

Neck joint range of motion measurement

时间窗: First month post-treatment

Active neck range of motion, which shows the movement of the neck in all directions, is evaluated by goniometric measurement.

次要结局

  • Side effects(Through study completion, an average of 6 month.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Halil Ogut

Assistant Professor Doctor

Mustafa Kemal University

研究点 (1)

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