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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

Comparison Of The Efficacy Of Interfascial Hydrodissection With A Mixture Of Lidocaine And Physiological Saline Solution Wıth 10% Dextrose In Patients With Chronic Neck Pain Associated With Resistant Myofascial Trigger Points In The Upper Trapezius

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07503574
Enrollment
96
Registered
2026-03-31
Start date
2025-04-30
Completion date
2025-08-15
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

myofascial pain syndrome, hydrodissection, dextrose, lidocain, ultrasound

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.

Interventions

DRUG% 10 dextrose Hydrodissection

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.

DRUGLidocaine-Saline Hydrodissection

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.

Sponsors

Ankara University
Lead SponsorOTHER
Ankara Training and Research Hospital
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The investigator and outcome assessor will be blinded for the interventions.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
VAS (Visual analog scale)0., 1. and 3. monthsVAS: 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.

Secondary

MeasureTime frameDescription
Servical range of motion (ROM)0., 1. and 3. monthsServical range of motion (ROM), is assessed in six basic directions: flexion, extension, right and left lateral flexion, and right and left rotation. During measurements, the individual is positioned sitting with their feet flat on the floor. For the extension measurement, the participant is asked to actively bend their head backward in a controlled manner; for flexion, they are asked to actively bend their head forward without moving their torso. During lateral flexion, the individual is asked to bring their ear as close as possible to the shoulder on the same side; for the rotation assessment, they are expected to actively turn their chin toward their shoulder. In all these movements, the maximum angle achieved is measured and recorded using a goniometer. Normal ROM of servical flexion is 45-50 degree; extension is 60 degree; lateral flexion is 45 degree; rotation is 70-80 degree.
Short form (SF)-120., 1. and 3. monthsQuality of life is assessed with Short form (SF)-12: It is a short 12-item form derived from the SF-36 scale, developed to assess individuals' quality of life. The scale provides two separate total scores reflecting physical and mental health status. Higher scores indicate that the person's overall perception of health is better. Interpret the PCS and MCS scores using a norm-based scoring system with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate health-related quality of life above average, while scores below 50 indicate impaired quality of life.
NDI0., 1. and 3. monthsNeck disability index (NDI): The questionnaire aims to measure patients' subjective symptoms related to neck pain and the level of limitation in their daily living activities. It consists of 10 sections in total: pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep, and leisure activities. Each section contains 6 options rated from 0 to 5. The total score ranges from 0 to 50, with higher scores indicating a greater level of disability.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026