Chronic Shoulder PainNCT07428512
Comparison of the Effectiveness of 5% and 10% Dextrose Treatments in Patients With Chronic Shoulder Pain: Ultrasound-Guided Perineural Injection
A study testing dextrose in people with Chronic Shoulder Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Chronic shoulder pain is a condition that typically lasts longer than three months and affects daily life. Among musculoskeletal system pathologies, shoulder pain ranks third after spine and knee pathologies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2025to 15 Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old with shoulder pain for the past 6 months who have not responded to medical treatment, exercise, corticosteroid injections, or physical therapy modalities, and who are willing to participate in the study.
Who cannot join
- Patients younger than 18 or older than 75 years
- Patients with a history of surgery on the same shoulder
- Patients with neurological and/or inflammatory diseases
- Patients with serious systemic diseases such as malignancy, end-stage congestive heart failure, or uncontrolled diabetes
- Patients with insufficient cognitive function
Trial locations and contacts
1 site in 1 country.
About this study
Chronic shoulder pain is a condition that typically lasts longer than three months and affects daily life. Among musculoskeletal system pathologies, shoulder pain ranks third after spine and knee pathologies. Patients with chronic shoulder pain often experience significant functional loss and reduced psychosocial well-being. Chronic shoulder pain may originate from instability, rotator cuff pathologies (calcific tendinitis, tendinopathy, full-thickness or partial tears), the acromioclavicular joint, adhesive capsulitis, or the glenohumeral joint. It results in pain, decreased joint range of motion, stiffness, limitations in activities of daily living, and ultimately disability. Musculoskeletal disorders constitute a significant health problem in the aging global population.
Treatment options include patient education, lifestyle modifications, exercise, physical therapy modalities, medical treatments, intra-articular injections, periarticular injections, and suprascapular nerve block. The suprascapular nerve is a large peripheral nerve containing both motor and sensory fibers. It originates from the ventral rami of the C5 and C6 cervical nerve roots and may occasionally receive contributions from the C4 nerve root. The nerve arises from the lateral aspect of the upper trunk of the brachial plexus, passes beneath the omohyoid and trapezius muscles, and reaches the supraspinous fossa by passing under the suprascapular notch. The suprascapular nerve gives motor branches to the supraspinatus muscle and sensory branches to the acromioclavicular joint, coracoclavicular ligament, and the posterior part of the subacromial bursa. Compared with intra-articular injections, suprascapular nerve block has been shown to provide faster and greater effectiveness. This increases patient adherence to exercise, facilitates a quicker return to activities of daily living, and helps prevent further chronicity of the condition.
Read more
A 5% dextrose solution is frequently used for perineural injections and has an osmolality similar to normal saline. Although its neural mechanism is not fully understood, it is thought to inhibit vanilloid receptor activation and block the release of substance P and calcitonin gene-related peptide (CGRP). Hypertonic dextrose (>10%) may trigger local inflammation and promote tissue regeneration and symptom relief, while also increasing fibroblast proliferation and stimulating collagen synthesis and tissue healing.
The primary aim of our study is to investigate and compare the effects of 5% and 10% dextrose injections around the suprascapular nerve on pain, joint range of motion, functionality, and kinesiophobia, and to determine their relative superiority. The secondary aim is to evaluate the effects of these injection treatments on supraspinatus muscle and tendon thickness, as well as quality of life, in association with improved adherence to exercise.
- Conditions
- Chronic Shoulder Pain
- Being tested
- dextrose
- Keywords
- pain, 10% dextrose, 5% dextrose, Perineural injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dextroseDrug
Participants will receive ultrasound-guided perineural injections around the suprascapular nerve using either 5% or 10% dextrose solution. The injections aim to reduce pain, improve joint range of motion, enhance shoulder functionality, decrease kinesiophobia, and promote adherence to prescribed exercise programs. The 5% dextrose solution is isotonic, while the 10% dextrose solution is hypertonic and may additionally stimulate local tissue regeneration and collagen synthesis. Treatments will be administered under sterile conditions by an experienced clinician, and participants will be monitored for immediate and long-term effects on pain, muscle/tendon thickness, functional outcomes, and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| 10% dextrose | Active comparator | Not described Receives: Drug: dextrose |
| 5% dextrose | Active comparator | Not described Receives: Drug: dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Patients indicate their pain on a 100 mm line, where 0 represents "no pain" and 100 represents "unbearable pain." The distance from 0 to the patient's mark reflects pain severity.
Measured: baseline,after 1 month and 3 months changes
Shoulder Range of Motion (ROM)
Clinician-assessed using a standard goniometer. Passive flexion, abduction, internal rotation, and external rotation of the affected shoulder will be measured.
Measured: baseline,after 1 month and 3 months changes
Shoulder Pain and Disability Index (SPADI)
Includes two subscales: pain (5 items) and disability (8 items). Responses are scored from 0-10. Subscale scores are calculated as a percentage of the maximum possible score, with higher scores indicating increased pain and reduced shoulder function.
Measured: baseline,after 1 month and 3 months changes
Kinesiophobia
Assessed using the Tampa Scale of Kinesiophobia (17 items, 4-point Likert scale, total score 17-68). Higher scores indicate higher fear of movement.
Measured: baseline,after 1 month and 3 months changes
Secondary outcomes (2)
Short Form-12 (SF-12) questionnaire
Assessed using the Short Form-12 (SF-12) questionnaire. The SF-12 evaluates physical and mental health dimensions, including physical functioning, social functioning, role limitations due to physical and emotional problems, mental health, energy/fatigue, pain, and general health perception.
Measured: baseline,after 1 month and 3 months changes
Supraspinatus Muscle and Tendon Thickness
Measured by ultrasound (LOGIQ 9 device).
Supraspinatus tendon thickness: Measured in the Crass position, with the shoulder in extension, adduction, and external rotation. Measurement is taken 10 mm lateral to the intra-articular portion of the long head of the biceps tendon at the rotator interval.
Measured: baseline,after 1 month and 3 months changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start9 Jul 2025
- Primary completion15 Dec 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Shoulder PainStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428512
- Sponsor's protocol ID
- E2-25-11819
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of 5% and 10% Dextrose Treatments in Patients With Chronic Shoulder Pain: Ultrasound-Guided Perineural Injection
- ClinicalTrials.gov ID
- NCT07428512
- Acronym / sponsor ID
- E2-25-11819
- Conditions
- Chronic Shoulder Pain
- Keywords
- pain, 10% dextrose, 5% dextrose, Perineural injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 23 Feb 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.
Chronic shoulder pain is a condition that typically lasts longer than three months and affects daily life. Among musculoskeletal system pathologies, shoulder pain ranks third after spine and knee pathologies. Patients with chronic shoulder pain often experience significant functional loss and reduced psychosocial well-being. Chronic shoulder pain may originate from instability, rotator cuff pathologies (calcific tendinitis, tendinopathy, full-thickness or partial tears), the acromioclavicular joint, adhesive capsulitis, or the glenohumeral joint. It results in pain, decreased joint range of motion, stiffness, limitations in activities of daily living, and ultimately disability. Musculoskeletal disorders constitute a significant health problem in the aging global population.
Treatment options include patient education, lifestyle modifications, exercise, physical therapy modalities, medical treatments, intra-articular injections, periarticular injections, and suprascapular nerve block. The suprascapular nerve is a large peripheral nerve containing both motor and sensory fibers. It originates from the ventral rami of the C5 and C6 cervical nerve roots and may occasionally receive contributions from the C4 nerve root. The nerve arises from the lateral aspect of the upper trunk of the brachial plexus, passes beneath the omohyoid and trapezius muscles, and reaches the supraspinous fossa by passing under the suprascapular notch. The suprascapular nerve gives motor branches to the supraspinatus muscle and sensory branches to the acromioclavicular joint, coracoclavicular ligament, and the posterior part of the subacromial bursa. Compared with intra-articular injections, suprascapular nerve block has been shown to provide faster and greater effectiveness. This increases patient adherence to exercise, facilitates a quicker return to activities of daily living, and helps prevent further chronicity of the condition.
A 5% dextrose solution is frequently used for perineural injections and has an osmolality similar to normal saline. Although its neural mechanism is not fully understood, it is thought to inhibit vanilloid receptor activation and block the release of substance P and calcitonin gene-related peptide (CGRP). Hypertonic dextrose (>10%) may trigger local inflammation and promote tissue regeneration and symptom relief, while also increasing fibroblast proliferation and stimulating collagen synthesis and tissue healing.
The primary aim of our study is to investigate and compare the effects of 5% and 10% dextrose injections around the suprascapular nerve on pain, joint range of motion, functionality, and kinesiophobia, and to determine their relative superiority. The secondary aim is to evaluate the effects of these injection treatments on supraspinatus muscle and tendon thickness, as well as quality of life, in association with improved adherence to exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10% dextrose | Active comparator | Drug: dextrose |
| 5% dextrose | Active comparator | Drug: dextrose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old with shoulder pain for the past 6 months who have not responded to medical treatment, exercise, corticosteroid injections, or physical therapy modalities, and who are willing to participate in the study.
Key exclusion criteria (5 listed)
- Patients younger than 18 or older than 75 years
- Patients with a history of surgery on the same shoulder
- Patients with neurological and/or inflammatory diseases
- Patients with serious systemic diseases such as malignancy, end-stage congestive heart failure, or uncontrolled diabetes
- Patients with insufficient cognitive function
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 |
|---|---|---|
| dextroseParticipants will receive ultrasound-guided perineural injections around the suprascapular nerve using either 5% or 10% dextrose solution. The injections aim to reduce pain, improve joint range of motion, enhance shoulder functionality, decrease kinesiophobia, and promote adherence to prescribed exercise programs. The 5% dextrose solution is isotonic, while the 10% dextrose solution is hypertonic and may additionally stimulate local tissue regeneration and collagen synthesis. Treatments will be administered under sterile conditions by an experienced clinician, and participants will be monitored for immediate and long-term effects on pain, muscle/tendon thickness, functional outcomes, and quality of life. | Drug | 10% dextrose, 5% dextrose |
Primary outcome
Visual Analog Scale
Time frame: baseline,after 1 month and 3 months changes
Patients indicate their pain on a 100 mm line, where 0 represents "no pain" and 100 represents "unbearable pain." The distance from 0 to the patient's mark reflects pain severity.
Shoulder Range of Motion (ROM)
Time frame: baseline,after 1 month and 3 months changes
Clinician-assessed using a standard goniometer. Passive flexion, abduction, internal rotation, and external rotation of the affected shoulder will be measured.
Shoulder Pain and Disability Index (SPADI)
Time frame: baseline,after 1 month and 3 months changes
Includes two subscales: pain (5 items) and disability (8 items). Responses are scored from 0-10. Subscale scores are calculated as a percentage of the maximum possible score, with higher scores indicating increased pain and reduced shoulder function.
Kinesiophobia
Time frame: baseline,after 1 month and 3 months changes
Assessed using the Tampa Scale of Kinesiophobia (17 items, 4-point Likert scale, total score 17-68). Higher scores indicate higher fear of movement.
2 secondary outcomes
Short Form-12 (SF-12) questionnaire
Time frame: baseline,after 1 month and 3 months changes
Supraspinatus Muscle and Tendon Thickness
Time frame: baseline,after 1 month and 3 months changes
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 23 Feb 2026.
- Individual participant dataSharing planned: No
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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 dextrose in people with Chronic Shoulder Pain, run by Ankara City Hospital Bilkent 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 1 inclusion and 5 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 23 Feb 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?
Visual Analog Scale (time frame: baseline,after 1 month and 3 months changes). The study lists 4 primary outcomes in all. 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 23 Feb 2026.