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Completed

NCT Number: NCT07503574

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

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.

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trigger Point Pain, Myofascial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

% 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.

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.

Primary outcomes

  1. VAS (Visual analog scale)

    Time frame: 0., 1. and 3. months

    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.

Secondary outcomes

  1. Servical range of motion (ROM)

    Time frame: 0., 1. and 3. months

    Servical 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.

  2. Short form (SF)-12

    Time frame: 0., 1. and 3. months

    Quality 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.

  3. NDI

    Time frame: 0., 1. and 3. months

    Neck 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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

  • Ankara Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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