Myofascial Pain SyndromeNCT07503574
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
A study testing % 10 dextrose Hydrodissection and Lidocaine-Saline Hydrodissection in people with Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome, Trigger Point Pain, Myofascial, Neck Pain
- What is being tested?
- % 10 dextrose Hydrodissection and Lidocaine-Saline Hydrodissection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Ankara, 06010
About this study
Official 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
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.
- Being tested
- % 10 dextrose Hydrodissection, Lidocaine-Saline Hydrodissection
- Keywords
- myofascial pain syndrome, hydrodissection, dextrose, lidocain, ultrasound
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
% 10 dextrose HydrodissectionDrug
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 HydrodissectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: Dextrose Hydrodissection | Active comparator | Ultrasound-guided interfascial hydrodissection in patients with chronic servical pain by using a %10 dextrose Receives: 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. Receives: Drug: Lidocaine-Saline Hydrodissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0., 1. and 3. months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 0., 1. and 3. months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start30 Apr 2025
- Primary completion30 Jul 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Responsible party
- Principal investigator, Server Fidelya Ekmekci, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503574
- Sponsor's protocol ID
- AEŞH-EK-2025-128
- Status last verified
- Mar 2026
- First submitted
- 21 Nov 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07503574
- Acronym / sponsor ID
- AEŞH-EK-2025-128
- Keywords
- myofascial pain syndrome, hydrodissection, dextrose, lidocain, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ARM 1: Dextrose Hydrodissection | Active comparator | Drug: % 10 dextrose HydrodissectionUltrasound-guided interfascial hydrodissection in patients with chronic servical pain by using a %10 dextrose |
| ARM 2: Lidocaine- Saline Hydrodissection | Active comparator | Drug: Lidocaine-Saline HydrodissectionUltrasound-guided interfascial hydrodissection of patients with chronic servical pain by using a mixture of lidocaine and physiological saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| % 10 dextrose HydrodissectionUltrasound-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. | Drug | ARM 1: Dextrose Hydrodissection |
| Lidocaine-Saline HydrodissectionUltrasound-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. | Drug | ARM 2: Lidocaine- Saline Hydrodissection |
Primary outcome
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.
3 secondary outcomes
Servical range of motion (ROM)
Time frame: 0., 1. and 3. months
Short form (SF)-12
Time frame: 0., 1. and 3. months
NDI
Time frame: 0., 1. and 3. months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Additional Effect of Interfascial Hydrodissection With Dextrose on Shoulder and Neck Function in Patients With Myofascial Pain Syndrome: A Randomized Control TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Myofascial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing % 10 dextrose Hydrodissection and Lidocaine-Saline Hydrodissection in people with Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual analog scale) (time frame: 0., 1. and 3. months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.