NCT07462988

Comparison of Mesotherapy Treatment Doses in Patients With Chronic Non-Specific Neck Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Istanbul Medeniyet University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Our treatment protocol was designed based on the Treatment Algorithm published by the Italian Mesotherapy Society in 2012 (4). All patients will be instructed to continue their usual daily activities and regularly used medications, but avoid participating in any other treatment program. If they need additional medication, they will be asked to record the type and number of tablets taken. Patients will be instructed not to apply any lotions or creams to the injection area before the session. Mesotherapy and saline injections will be performed by the same practitioner at the Department of Physical Medicine and Rehabilitation at Göztepe Prof. Dr. Süleyman Yalçın City Hospital. Single-use 30G x 4 mm (Meso-Relle, Biotekne SRL, Italy) needles will be used. All injections will be prepared cleanly and performed in accordance with routine aseptic procedures. Patients included in the study will be randomly assigned to four groups of 22 using sealed envelopes. A total of 88 envelopes will be prepared, each containing equal numbers of group labels: 1 (dry mesotherapy), 2 (mesotherapy with saline), 3 (mesotherapy with lidocaine and meloxicam), and 4 (mesotherapy with half-dose lidocaine and meloxicam). Patients will be asked to select one envelope. In this double-blind study, to ensure blinding of patients to the injectate, the solutions will be prepared by the practitioner before the patient enters the procedure room. The evaluator will be blinded to the patient's group and the injection performed. For each session, the mesotherapy mixtures will be prepared according to the group. A total of 30-35 microinjections will be administered bilaterally between the occiput and the C7 vertebra using the nappage technique. In dry mesotherapy, only needle insertion will be performed without injecting any solution. Questionnaires will be administered before and after the sessions, as well as one month and six months after completing the sessions. Demographic data such as age, height, weight, occupation, marital status, and education level will be recorded. Medications used and comorbidities will be documented. The onset and localization of neck pain will be assessed. Pain will be evaluated with the Visual Analog Scale (VAS) and algometry. The Neck Disability Index (NDI) will be used to assess the impact of neck pain on daily activities. The SF-12 will be used to assess quality of life. These assessments will be performed at baseline, one month after baseline, and three months after baseline. Post-treatment, patients may experience local infections, subcutaneous nodules, or scarring. When performed according to technical guidelines and aseptic procedures, risks will be minimized.

Conditions

• Neck Pain
• Mesotherapy

Interventions

Type	Name	Description
DRUG	Lidocaine %2 ampoule	Randomised controlled comparison of mesotherapy doses and interventions
DRUG	Meloxicam ampoule	Randomised controlled comparison of mesotherapy doses and interventions
DRUG	Saline (0.9% NaCl)	Randomised controlled comparison of mesotherapy doses and interventions
OTHER	Dry Needling	injection using only a mesotherapy needle

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-01
• Completion: 2025-11-01
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Turkey (Türkiye)