Rotator Cuff DiseaseNCT04805242
Effects of Dextrose Prolotherapy in Rotator Cuff Disease
A study testing Dextrose prolotherapy injection and Lidocaine-saline injection in people with Rotator Cuff Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective, randomized, controlled trial was to evaluate the clinical and ultrasonographic effects of dextrose prolotherapy on pain, shoulder function, range of motion, and ultrasonographic findings in patients with MRI-confirmed chronic rotator cuff disease. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Rotator Cuff Disease
- What is being tested?
- Dextrose prolotherapy injection and Lidocaine-saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2021to 12 Nov 2021
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 65 years
- Shoulder pain lasting longer than 3 months
- Resistance to conservative treatment for at least 3 months
- Diagnosis of rotator cuff disease confirmed by clinical examination and magnetic resonance imaging (MRI)
Who cannot join
- Presence of rheumatic disease or other systemic inflammatory diseases
- Uncontrolled diabetes mellitus
- Local or systemic infection
- History of previous shoulder surgery
- Bleeding tendency (acquired or hereditary) or use of anticoagulant therapy with INR >2
- Shoulder injection within the previous 8 weeks
Show all 11Show fewer
- Allergy to local anesthetics
- Passive shoulder abduction <100° or external rotation <25°
- Rotator cuff calcification with diameter >0.8 cm detected on radiography or ultrasonography
- Full-thickness rotator cuff tear
- Presence of severe comorbid disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, 34034
About this study
Official title: Effects of Dextrose Prolotherapy in Rotator Cuff Disease: A Randomized Controlled Study
The aim of this prospective, randomized, controlled trial was to evaluate the clinical and ultrasonographic effects of dextrose prolotherapy on pain, shoulder function, range of motion, and ultrasonographic findings in patients with MRI-confirmed chronic rotator cuff disease. Participants were randomly assigned to receive either dextrose prolotherapy or lidocaine-saline injections. Both groups followed a standardized home-based exercise program.
Read the detailed description
Rotator cuff disease is a major cause of persistent shoulder pain and functional limitation. Although exercise therapy, nonsteroidal anti-inflammatory drugs, and subacromial corticosteroid injections are commonly used as first-line treatments, many patients remain symptomatic despite conservative management. Dextrose prolotherapy has emerged as a potential treatment option for chronic musculoskeletal disorders; however, evidence from randomized controlled trials in chronic rotator cuff disease remains limited and inconsistent.
This prospective, randomized, controlled trial enrolled 60 patients with MRI-confirmed chronic rotator cuff disease who met the eligibility criteria. Participants were randomly assigned using a computer-generated randomization sequence to receive either dextrose prolotherapy or lidocaine-saline injections. In the dextrose prolotherapy group, injections were administered at baseline, week 3, and week 6 using an ultrasound-guided anatomical marking technique under aseptic conditions. In the lidocaine-saline injection group, injections were administered at the same time points using the same ultrasound-guided anatomical marking technique and injection protocol. Both groups participated in a standardized home-based exercise program throughout the study.
Outcome assessments were performed at baseline and at 4 and 12 weeks after the final injection. The primary outcome was activity-related pain measured using the Visual Analog Scale (VAS). Secondary outcomes included pain at rest, nocturnal pain, the Shoulder Pain and Disability Index (SPADI), the UCLA Shoulder Rating Scale, active shoulder range of motion, and the Ultrasound Shoulder Pathology Rating Scale (USPRS). Outcome assessments were performed by an investigator blinded to treatment allocation.
- Conditions
- Rotator Cuff Disease
- Being tested
- Dextrose prolotherapy injection, Lidocaine-saline injection
- Keywords
- Rotator Cuff Disease, Dextrose Prolotherapy, Shoulder Pain, Regenerative Injection Therapy, Shoulder Tendinopathy, Rotator Cuff Tendinopathy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose prolotherapy injectionOther
Dextrose prolotherapy injections were administered at baseline, week 3, and week 6 using an ultrasound-guided anatomical marking technique. A 15% dextrose solution was prepared using 30% dextrose, saline, and 1% lidocaine. Extra-articular injections were administered with a 27-gauge needle using the peppering technique at five previously marked anatomical points, including the long head of the biceps tendon in the bicipital groove, the subscapularis insertion at the lesser tuberosity, the supraspinatus insertion at the greater tuberosity, the infraspinatus insertion at the greater tuberosity, and the coracoid process region. One milliliter was injected at each point. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of solution was injected into the subacromial bursa. All participants also received a standardized home-based exercise program.
Lidocaine-saline injectionOther
Lidocaine-saline injections were administered at baseline, week 3, and week 6 using the same ultrasound-guided anatomical marking technique and anatomical targets as the prolotherapy group. Extra-articular injections were prepared using saline and 1% lidocaine and were administered superficially at approximately 0.5-1 cm depth using a 26-gauge needle at five previously marked sites to mimic the prolotherapy injection procedure. One milliliter was injected at each site. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of lidocaine-saline solution was injected into the subacromial bursa. All participants also received a standardized home-based exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Dextrose prolotherapy | Experimental | Participants in this group received ultrasound-guided dextrose prolotherapy injections at baseline, week 3, and week 6 using an anatomical marking technique, in addition to a standardized home-based exercise program. Receives: Other: Dextrose prolotherapy injection |
| Lidocaine-saline injections | Active comparator | Participants in this group received ultrasound-guided lidocaine-saline injections at baseline, week 3, and week 6 using the same anatomical marking technique and injection protocol as the prolotherapy group, in addition to a standardized home-based exercise program. Receives: Other: Lidocaine-saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activity-related pain measured by the Visual Analog Scale (VAS)
Activity-related pain was measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain severity.
Measured: Baseline, 4 weeks, and 12 weeks after the final injection
Secondary outcomes (6)
Change in rest pain measured by the Visual Analog Scale (VAS)
Resting shoulder pain was measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain severity.
Measured: Baseline, 4 weeks, and 12 weeks after the final injection
Change in night pain measured by the Visual Analog Scale (VAS)
Night shoulder pain was measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain severity.
Measured: Baseline, 4 weeks, and 12 weeks after the final injection
Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI consists of 13 items divided into pain and disability subscales. Scores range from 0 to 100, with higher scores indicating greater pain and functional impairment.
Measured: Baseline, 4 weeks, and 12 weeks after the final injection
Change in shoulder function measured by the UCLA Shoulder Rating Scale
Shoulder function was assessed using the UCLA Shoulder Rating Scale. The scale evaluates pain, function, active forward flexion, strength of forward flexion, and patient satisfaction. Scores range from 0 to 35, with higher scores indicating better shoulder function.
Measured: Baseline, 4 weeks, and 12 weeks after the final injection
Change in rotator cuff structural pathology measured by the Ultrasound Shoulder Pathology Rating Scale (USPRS)
Rotator cuff structural abnormalities were assessed using the Ultrasound Shoulder Pathology Rating Scale (USPRS) based on ultrasonographic findings. Higher scores indicate greater structural pathology.
Measured: Baseline, 4 weeks, and 12 weeks after the final injection
Change in shoulder active range of motion (ROM)
Active shoulder range of motion was measured using a goniometer, including flexion, abduction, internal rotation, and external rotation. Higher values indicate greater shoulder mobility.
Measured: Baseline, 4 weeks, and 12 weeks after the final injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start18 Mar 2021
- Primary completion12 Oct 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to receive either dextrose prolotherapy injections or lidocaine-saline injections in a parallel-group design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Sezikli, Istanbul University
- Investigators
- Selim Sezikli, MD, Principal investigator, Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and RehabilitationDemirhan Diracoglu, Prof., Study director, Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805242
- Sponsor's protocol ID
- Shoulder Prolotherapy
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dextrose Prolotherapy in Rotator Cuff Disease: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04805242
- Acronym / sponsor ID
- Shoulder Prolotherapy
- Conditions
- Rotator Cuff Disease
- Keywords
- Rotator Cuff Disease, Dextrose Prolotherapy, Shoulder Pain, Regenerative Injection Therapy, Shoulder Tendinopathy, Rotator Cuff Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 18 Mar 2021 (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.
The aim of this prospective, randomized, controlled trial was to evaluate the clinical and ultrasonographic effects of dextrose prolotherapy on pain, shoulder function, range of motion, and ultrasonographic findings in patients with MRI-confirmed chronic rotator cuff disease. Participants were randomly assigned to receive either dextrose prolotherapy or lidocaine-saline injections. Both groups followed a standardized home-based exercise program.
Detailed description
Rotator cuff disease is a major cause of persistent shoulder pain and functional limitation. Although exercise therapy, nonsteroidal anti-inflammatory drugs, and subacromial corticosteroid injections are commonly used as first-line treatments, many patients remain symptomatic despite conservative management. Dextrose prolotherapy has emerged as a potential treatment option for chronic musculoskeletal disorders; however, evidence from randomized controlled trials in chronic rotator cuff disease remains limited and inconsistent.
This prospective, randomized, controlled trial enrolled 60 patients with MRI-confirmed chronic rotator cuff disease who met the eligibility criteria. Participants were randomly assigned using a computer-generated randomization sequence to receive either dextrose prolotherapy or lidocaine-saline injections. In the dextrose prolotherapy group, injections were administered at baseline, week 3, and week 6 using an ultrasound-guided anatomical marking technique under aseptic conditions. In the lidocaine-saline injection group, injections were administered at the same time points using the same ultrasound-guided anatomical marking technique and injection protocol. Both groups participated in a standardized home-based exercise program throughout the study.
Outcome assessments were performed at baseline and at 4 and 12 weeks after the final injection. The primary outcome was activity-related pain measured using the Visual Analog Scale (VAS). Secondary outcomes included pain at rest, nocturnal pain, the Shoulder Pain and Disability Index (SPADI), the UCLA Shoulder Rating Scale, active shoulder range of motion, and the Ultrasound Shoulder Pathology Rating Scale (USPRS). Outcome assessments were performed by an investigator blinded to treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized to receive either dextrose prolotherapy injections or lidocaine-saline injections in a parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| Dextrose prolotherapy | Experimental | Other: Dextrose prolotherapy injectionParticipants in this group received ultrasound-guided dextrose prolotherapy injections at baseline, week 3, and week 6 using an anatomical marking technique, in addition to a standardized home-based exercise program. |
| Lidocaine-saline injections | Active comparator | Other: Lidocaine-saline injectionParticipants in this group received ultrasound-guided lidocaine-saline injections at baseline, week 3, and week 6 using the same anatomical marking technique and injection protocol as the prolotherapy group, in addition to a standardized home-based exercise program. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 30 and 65 years
- Shoulder pain lasting longer than 3 months
- Resistance to conservative treatment for at least 3 months
- Diagnosis of rotator cuff disease confirmed by clinical examination and magnetic resonance imaging (MRI)
Key exclusion criteria (11 listed)
- Presence of rheumatic disease or other systemic inflammatory diseases
- Uncontrolled diabetes mellitus
- Local or systemic infection
- History of previous shoulder surgery
- Bleeding tendency (acquired or hereditary) or use of anticoagulant therapy with INR >2
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 |
|---|---|---|
| Dextrose prolotherapy injectionDextrose prolotherapy injections were administered at baseline, week 3, and week 6 using an ultrasound-guided anatomical marking technique. A 15% dextrose solution was prepared using 30% dextrose, saline, and 1% lidocaine. Extra-articular injections were administered with a 27-gauge needle using the peppering technique at five previously marked anatomical points, including the long head of the biceps tendon in the bicipital groove, the subscapularis insertion at the lesser tuberosity, the supraspinatus insertion at the greater tuberosity, the infraspinatus insertion at the greater tuberosity, and the coracoid process region. One milliliter was injected at each point. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of solution was injected into the subacromial bursa. All participants also received a standardized home-based exercise program. | Other | Dextrose prolotherapy |
| Lidocaine-saline injectionLidocaine-saline injections were administered at baseline, week 3, and week 6 using the same ultrasound-guided anatomical marking technique and anatomical targets as the prolotherapy group. Extra-articular injections were prepared using saline and 1% lidocaine and were administered superficially at approximately 0.5-1 cm depth using a 26-gauge needle at five previously marked sites to mimic the prolotherapy injection procedure. One milliliter was injected at each site. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of lidocaine-saline solution was injected into the subacromial bursa. All participants also received a standardized home-based exercise program. | Other | Lidocaine-saline injections |
Primary outcome
Change in activity-related pain measured by the Visual Analog Scale (VAS)
Time frame: Baseline, 4 weeks, and 12 weeks after the final injection
Activity-related pain was measured using a 10-cm Visual Analog Scale (VAS). Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain severity.
6 secondary outcomes
Change in rest pain measured by the Visual Analog Scale (VAS)
Time frame: Baseline, 4 weeks, and 12 weeks after the final injection
Change in night pain measured by the Visual Analog Scale (VAS)
Time frame: Baseline, 4 weeks, and 12 weeks after the final injection
Change in shoulder pain and disability measured by the Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline, 4 weeks, and 12 weeks after the final injection
Change in shoulder function measured by the UCLA Shoulder Rating Scale
Time frame: Baseline, 4 weeks, and 12 weeks after the final injection
Change in rotator cuff structural pathology measured by the Ultrasound Shoulder Pathology Rating Scale (USPRS)
Time frame: Baseline, 4 weeks, and 12 weeks after the final injection
Change in shoulder active range of motion (ROM)
Time frame: Baseline, 4 weeks, and 12 weeks after the final injection
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 2 Jul 2026.
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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.
Selim Sezikli, MD principal investigator
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Demirhan Diracoglu, Prof. study director
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
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 prolotherapy injection and Lidocaine-saline injection in people with Rotator Cuff Disease, run by Istanbul 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 4 inclusion and 11 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 2 Jul 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?
Change in activity-related pain measured by the Visual Analog Scale (VAS) (time frame: Baseline, 4 weeks, and 12 weeks after the final injection). 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 2 Jul 2026.