- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06010
- Ankara Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ARM 1: Dextrose Hydrodissection
Ultrasound-guided interfascial hydrodissection in patients with chronic servical pain by using a %10 dextrose
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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.
|
|
Active Comparator: ARM 2: Lidocaine- Saline Hydrodissection
Ultrasound-guided interfascial hydrodissection of patients with chronic servical pain by using a mixture of lidocaine and physiological saline.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
0., 1. and 3. months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
0., 1. and 3. months
|
|
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.
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0., 1. and 3. months
|
|
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.
|
0., 1. and 3. months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK-2025-128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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