Comparison Of The Efficacy Of Interfascial Hydrodissection With A Mixture Of Lidocaine And Physiological Saline Solution With 10% Dextrose In Patients With Chronic Neck Pain

NCT07503574 | Completed DMC

• 1 other identifier: AEŞH-EK-2025-128
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study aimed to investigate the effects of fascial hydrodissection with 10% dextrose or lidocaine-saline on pain, neck functions, and quality of daily life in patients with chronic neck pain due to resistant myofascial trigger points in the upper trapezius muscle unresponsive to conservative treatments, and to determine whether one solution is superior to the other. Materials and Methods: This study is designed as prospective, comparative clinical study. The first group will be applied interfascial hydrodissection with 10% dextrose, and the second group with lidocaine-saline. All participants will be instructed in self-massage and stretching exercises to perform at home to support treatment efficacy. Interventions will be performed under ultrasound guidance, targeting the specified interfascial plane. Evaluations will be conducted at baseline, at 10 minutes post-treatment (VAS, ROM), and at 1-month and 3-month follow-ups (VAS, ROM, NDI, SF-12). Data will be statistically analyzied by comparing pre- and post-treatment measurements.

Conditions

Myofascial Pain Syndrome; Trigger Point Pain, Myofascial; Neck Pain

Keywords

myofascial pain syndrome; hydrodissection; dextrose; lidocain; ultrasound

Outcome Measures

Primary Outcomes (1)

• VAS (Visual analog scale)

  VAS: Visual analog scale: One of the commonly used methods for measuring pain intensity is the VAS score. This method relies on the patient rating their pain on a straight line with one end at 0 and the other at 10. 0: No pain; 10: The most severe pain.

  0., 1. and 3. months

Secondary Outcomes (3)

• Servical range of motion (ROM)

  0., 1. and 3. months

• Short form (SF)-12

  0., 1. and 3. months

• NDI

  0., 1. and 3. months

Study Arms (2)

ARM 1: Dextrose Hydrodissection

ACTIVE COMPARATOR

Ultrasound-guided interfascial hydrodissection in patients with chronic servical pain by using a %10 dextrose

Drug: % 10 dextrose Hydrodissection

ARM 2: Lidocaine- Saline Hydrodissection

ACTIVE COMPARATOR

Ultrasound-guided interfascial hydrodissection of patients with chronic servical pain by using a mixture of lidocaine and physiological saline.

Drug: Lidocaine-Saline Hydrodissection

Interventions

% 10 dextrose Hydrodissection DRUG

Ultrasound-guided interfascial hydrodissection using % 10 dextrose solution. Patients in dextrose group were injected with 8 ml of a 10% dextrose solution. The patient was placed in a sitting position and the trapezius muscle was visualized with ultrasound. A 22-gauge needle was then directed toward the interfascial area closest to the relevant myofascial trigger point using the in-plane technique. The targeted interfascial planes were defined as the areas between the trapezius and supraspinatus muscles and between the trapezius and levator scapulae muscles. When the needle tip reaches the hyperechoic line located between the trapezius muscle fascia and the fascia of the underlying muscle, hydrodissection is performed.

ARM 1: Dextrose Hydrodissection

Lidocaine-Saline Hydrodissection DRUG

Ultrasound-guided interfascial hydrodissection using a mixture of lidocaine and physiological saline. Lidocaine-saline group were injected with 2 ml of lidocaine hydrochloride (20 mg/ml) and 6 ml of a 0.9% sodium chloride mixture.

ARM 2: Lidocaine- Saline Hydrodissection

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-65 years old
• Chronic neck pain associated with MAS in the upper trapezius for at least 3 months and a VAS score above 5
• Compliance with the MAS criteria defined by Travel and Simons (five major and one minor criterion)
• Lack of response to conservative treatment methods such as medical and physical therapy for neck pain
• Willingness to participate in the study

You may not qualify if:

• Previous surgery on the shoulder or cervical region
• History of neck and shoulder trauma
• Presence of fibromyalgia syndrome
• Presence of cervical radiculopathy or shoulder pathologies
• Patients who have undergone injection or physical therapy program within the last three months
• History of lidocaine allergy
• Presence of coagulopathy
• Presence of rheumatological and neurological diseases
• Patients with uncontrolled diabetes mellitus
• Presence of severe psychiatric comorbidity
• Presence of local or systemic infection
• Presence of needle phobia

Sponsors & Collaborators

• Ankara University: lead
• Ankara Training and Research Hospital: collaborator

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

Related Links

• Additional Effect of Interfascial Hydrodissection With Dextrose on Shoulder and Neck Function in Patients With Myofascial Pain Syndrome: A Randomized Control Trial

MeSH Terms

Conditions

Myofascial Pain Syndromes; Neck Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcome assessor will be blinded for the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical medicine and Rehabilitation Specialist MD

Model Details: Patients in Group 1 (n=48) underwent interfascial hydrodissection with 10% dextrose under ultrasound guidance. Patients in Group 2 (n=48) underwent interfascial hydrodissection with a lidocaine-physiological saline mixture under ultrasound guidance.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: March 31, 2026
• Study Start: April 30, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 15, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)