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

NCT07462988 | Completed

• 1 other identifier: NECK PAIN MESOTHERAPY
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain; Mesotherapy

Keywords

mesotherapy; neck pain; meloxicam; lidocaine; VAS

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  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.

  Start, One month after the start, Three months after the start

Secondary Outcomes (3)

• 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

Study Arms (4)

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

Drug: Lidocaine %2 ampoule; Drug: Meloxicam ampoule

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

Drug: Lidocaine %2 ampoule; Drug: Meloxicam ampoule

Saline

ACTIVE COMPARATOR

mesotherapy with 3 cc of 0.9% saline

Drug: Saline (0.9% NaCl)

Dry Mesotherapy

ACTIVE COMPARATOR

without administering any substance with a mesotherapy needle

Other: Dry Needling

Interventions

Lidocaine %2 ampoule DRUG

Randomised controlled comparison of mesotherapy doses and interventions

Also known as: jetmonal

Half the Recommended Mesotherapy Dose; Recommended Mesotherapy Dose

Meloxicam ampoule DRUG

Randomised controlled comparison of mesotherapy doses and interventions

Also known as: melox

Half the Recommended Mesotherapy Dose; Recommended Mesotherapy Dose

Saline (0.9% NaCl) DRUG

Randomised controlled comparison of mesotherapy doses and interventions

Also known as: isotonic

Saline

Dry Needling OTHER

injection using only a mesotherapy needle

Dry Mesotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Goztepe Prof. Dr. Suleyman Yalçın City Hospital, Istanbul Medeniyet University

Istanbul, Kadıköy, 34722, Turkey (Türkiye)

Location

Related Publications (4)

• Sivagnanam G. Mesotherapy - The french connection. J Pharmacol Pharmacother. 2010 Jan;1(1):4-8. doi: 10.4103/0976-500X.64529.

  PMID: 21808584 RESULT

• Mammucari M, Gatti A, Maggiori S, Sabato AF. Role of mesotherapy in musculoskeletal pain: opinions from the italian society of mesotherapy. Evid Based Complement Alternat Med. 2012;2012:436959. doi: 10.1155/2012/436959. Epub 2012 May 13.

  PMID: 22654954 RESULT

• Herreros FO, Moraes AM, Velho PE. Mesotherapy: a bibliographical review. An Bras Dermatol. 2011 Jan-Feb;86(1):96-101. doi: 10.1590/s0365-05962011000100013. English, Portuguese.

  PMID: 21437529 RESULT

• Strine TW, Hootman JM. US national prevalence and correlates of low back and neck pain among adults. Arthritis Rheum. 2007 May 15;57(4):656-65. doi: 10.1002/art.22684.

  PMID: 17471542 RESULT

MeSH Terms

Conditions

Neck Pain

Interventions

Sodium Chloride; Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 10, 2026
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-02

Locations

TU (1)