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临床试验/NCT07462988
NCT07462988已完成不适用

Comparison of Mesotherapy Treatment Doses in Patients With Chronic Non-Specific Neck Pain: A Randomised Controlled Double-Blind Clinical Trial

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月1日最近更新:
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
Visual Analogue Scale (VAS)

研究概览

简要总结

Neck pain is a common health problem in the general population. Approximately 71% of adults experience neck pain at some point in their lives, and its annual prevalence ranges between 30-50% in both the general and working populations. Although neck pain often resolves spontaneously within a few days, it recurs or becomes chronic in about 10% of cases.

Mesotherapy was first described in 1958 by Dr. Michel Pistor as a treatment model based on intradermal injections. It involves administering small amounts of active substances into the superficial layers of the skin using specific injection techniques. Mesotherapy typically includes the application of analgesics, local anesthetics, muscle relaxants, and vasodilators. In addition to cosmetic indications, mesotherapy is also used to reduce pain in musculoskeletal conditions. In 2012, the Italian Society of Mesotherapy published a consensus report outlining the indications, contraindications, and scientific evidence regarding the use of mesotherapy in musculoskeletal pain. However, the exact mechanism of action of mesotherapy remains unclear.

The present study is designed as a prospective, single-blind, randomized controlled clinical trial to evaluate the effectiveness of mesotherapy in patients with neck pain. Before treatment, volunteers will be randomized into four groups by selecting a card. For each session, the following protocols will be applied:

Dry mesotherapy: Needling without injecting any medication.

Normal saline group: Mesotherapy with 3 cc of 0.9% NaCl.

Full-dose medication mixture: Mesotherapy with lidocaine (local anesthetic), meloxicam (analgesic), and 1 cc of 0.9% NaCl.

Half-dose medication mixture: Mesotherapy with half-dose lidocaine, half-dose meloxicam, and 1 cc of 0.9% NaCl.

All volunteers will receive one session per week for a total of three weeks. Improvement is expected in all groups, and the aim of the study is to determine which treatment protocol is the most effective in reducing pain and improving daily functioning.

Demographic data such as age, height, weight, occupation, marital status, and educational level will be recorded. Current medications and comorbid conditions will be assessed. The onset and location of neck pain will be documented. All personal information will be kept strictly confidential and will not be disclosed publicly; even if the study findings are published, the identities of the volunteers will remain anonymous.

Pain will be evaluated using the Visual Analog Scale (VAS) and an algometer. Health-related quality of life will be assessed with the 12-Item Short Form Health Survey (SF-12), and the impact of neck pain on daily activities will be evaluated using the Neck Disability Index (NDI). These assessments will be performed at baseline, one month, and three months after treatment. A total of 88 participants are planned to be included in the study.

Because mesotherapy involves superficial injections with very small amounts of medication, its risk profile is similar to other local injection procedures. The most common adverse effects are bruising, swelling, and mild allergic reactions at the injection site. Depending on the injection technique, pain, skin scratching, reactive cellulitis, and hematoma may occur. These effects are generally mild, uncommon, and self-limiting. When performed by experienced physicians with proper technique and appropriate medical equipment, the risk of complications is low.

详细描述

Neck pain affects 71% of adults at some point in their lives in the general population, with an annual prevalence ranging from 30% to 50% in both the general and working populations (1). Although neck pain usually resolves within a few days, it recurs or persists in 10% of cases (2).

The term mesotherapy was first used by Dr. Michel Pistor in 1958 in a local medical journal to describe a therapy model based on intradermal injections (3). Mesotherapy is a treatment method in which active substances are injected into the superficial layers of the skin using specific techniques (4). Analgesics, anesthetics, muscle relaxants, and vasodilators have been frequently used in mesotherapy. Beyond cosmetic applications, mesotherapy is also used to reduce pain (5). In 2012, the Italian Mesotherapy Society published a consensus report on the use, indications, contraindications, and scientific evidence of mesotherapy in musculoskeletal pain (6).

The exact mechanism of mesotherapy remains unclear. Because medications are administered locally via intradermal microinjections, the risk of systemic drug interactions is reduced, and side effects are significantly lower compared with conventional treatments. If proper aseptic procedures and techniques are not followed, adverse effects such as local infections, scarring, and subcutaneous nodules may occur (5).

The aim of our study is to compare mesotherapy treatment methods in patients with neck pain. Pain scores before and after injections will be evaluated using the Visual Analog Scale (VAS), pressure algometry, the Neck Disability Index (NDI), and the 12-Item Short Form Survey (SF-12). Patients aged 18-65 years with chronic neck pain lasting longer than three months will be included. Considering previous studies, a power analysis was conducted, and with a 10% dropout rate, 22 patients will be assigned to each group. Patients will be randomly divided into four groups: one group will receive dry mesotherapy, one group mesotherapy with 3 cc of 0.9% saline, one group mesotherapy with 1 cc of 2% lidocaine diluted 1:1, 1 cc of meloxicam diluted 3:1, and 1 cc of 0.9% saline, and one group mesotherapy with 1 cc of 2% lidocaine diluted 2:1, 1 cc of meloxicam diluted 7:1, and 1 cc of 0.9% saline. Treatments will be administered once weekly for three sessions.

Patients aged 18-65 years who have had neck pain for at least three months, have no radicular compression or muscle weakness, have no neurological or psychiatric condition that would prevent participation, and have received a clinical diagnosis from a specialist and provided informed consent will be included. Individuals with central nervous system diseases, distal peripheral nerve injuries, inflammatory joint diseases, a history of cervical spine or upper extremity surgery or fracture, tumors or infections of the cervical spine, or congenital anomalies involving the cervical spine will be excluded.

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
Double (Participant, Outcomes Assessor)

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

入选标准

  • Be aged 18-65 years.
  • Have experienced neck pain for at least three months.
  • Have no radicular compression or muscle weakness.
  • Have no neurological or psychiatric condition that would prevent participation.
  • Have received a clinical diagnosis from a specialist.
  • Provide informed consent to participate in the study.

排除标准

  • Central nervous system diseases.
  • Distal peripheral nerve injuries.
  • Inflammatory joint diseases.
  • A history of cervical spine or upper extremity surgery or fracture.
  • Tumors or infections of the cervical spine.
  • Congenital anomalies involving the cervical spine.

研究组 & 干预措施

Dry Mesotherapy

Active Comparator

without administering any substance with a mesotherapy needle

干预措施: Dry Needling (Other)

Recommended Mesotherapy Dose

Active Comparator

mesotherapy with 1 cc of 2% lidocaine diluted 1:1, 1 cc of meloxicam diluted 3:1, and 1 cc of 0.9% saline

干预措施: Lidocaine %2 ampoule (Drug)

Recommended Mesotherapy Dose

Active Comparator

mesotherapy with 1 cc of 2% lidocaine diluted 1:1, 1 cc of meloxicam diluted 3:1, and 1 cc of 0.9% saline

干预措施: Meloxicam ampoule (Drug)

Half the Recommended Mesotherapy Dose

Active Comparator

mesotherapy with 1 cc of 2% lidocaine diluted 2:1, 1 cc of meloxicam diluted 7:1, and 1 cc of 0.9% saline

干预措施: Lidocaine %2 ampoule (Drug)

Half the Recommended Mesotherapy Dose

Active Comparator

mesotherapy with 1 cc of 2% lidocaine diluted 2:1, 1 cc of meloxicam diluted 7:1, and 1 cc of 0.9% saline

干预措施: Meloxicam ampoule (Drug)

Saline

Active Comparator

mesotherapy with 3 cc of 0.9% saline

干预措施: Saline (0.9% NaCl) (Drug)

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: Start, One month after the start, Three months after the start

The Visual Analogue Scale (VAS) is a simple, widely used tool for assessing pain intensity. It typically consists of a 10-cm horizontal line anchored by "no pain" on one end and "worst imaginable pain" on the other. Patients mark a point on the line that corresponds to their pain level, which is then measured in millimeters. Higher scores indicate greater pain intensity. Rest pain, activity-related pain, and night pain were assessed.

次要结局

  • Neck Disability Index (NDI)(Start, one month after the start, three months after the start)
  • 12-Item Short Form Survey (SF-12)(Start, one month after the start, three months after the start)
  • Pressure Pain Threshold (PPT)(Start, one month after the start, three months after the start)

研究者

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

Bilinç Doğruöz Karatekin

dr

Istanbul Medeniyet University

研究点 (1)

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