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| Name | Class |
|---|---|
| Ankara Training and Research Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1: Dextrose Hydrodissection | Active Comparator | Ultrasound-guided interfascial hydrodissection in patients with chronic servical pain by using a %10 dextrose |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| % 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Servical range of motion (ROM) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Training and Research Hospital | Ankara | Ankara | 06010 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| Additional Effect of Interfascial Hydrodissection With Dextrose on Shoulder and Neck Function in Patients With Myofascial Pain Syndrome: A Randomized Control Trial | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2025 |
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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.
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The investigator and outcome assessor will be blinded for the interventions.
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| 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. |
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| 0., 1. and 3. months |
| Short form (SF)-12 | 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. | 0., 1. and 3. months |
| NDI | 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. | 0., 1. and 3. months |
| Mar 26, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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