Frozen ShoulderNCT06778577
The Efficacy of Suprascapular Nerve Radiofrequency and Intra-articular Steroid Injection in Frozen Shoulder Treatment
A study testing intra-articular corticosteroid injection (IACI) group and suprascapular nerve radiofrequency group (SCNRFT) in people with Frozen Shoulder and Radiofrequency Ablation Treatment, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to compare the effectiveness of suprascapular nerve pulsed radiofrequency and intra-articular steroid injection in patients with frozen shoulder (adhesive capsulitis). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Frozen Shoulder, Radiofrequency Ablation Treatment, Intra-articular Injection
- What is being tested?
- intra-articular corticosteroid injection (IACI) group and suprascapular nerve radiofrequency group (SCNRFT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 20 Oct 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral side involvement.
- ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
- duration of symptoms ≥3 months.
- age≥ 20year old.
- Patients with VAS ≥4 before the procedure
Who cannot join
- ever received manipulation of the affected shoulder with/without anesthesia. systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
- neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
- pain or disorders of the cervical spine, elbow, wrist, or hand.
- a history of drug allergy to local or corticosteroids.
- Pregnancy or lactation.
- Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks.
- Patients with VAS <4 before the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Department of Algology
Ankara, 06230
About this study
Official title: Comparison of the Efficacy of Ultrasound-guided Suprascapular Nerve Pulsed Radiofrequency Neuromodulation and Intra-articular Steroid Injection in Frozen Shoulder Treatment
The aim of this clinical study is to compare the effectiveness of suprascapular nerve pulsed radiofrequency and intra-articular steroid injection in patients with frozen shoulder (adhesive capsulitis). The main questions it aims to answer are:
- What is the effectiveness of intra-articular steroid injection in frozen shoulder?
- What is the effectiveness of suprascapular nerve radiofrequency in frozen shoulder?
- Should these two methods be used together in frozen shoulder?
- Being tested
- intra-articular corticosteroid injection (IACI) group, suprascapular nerve radiofrequency group (SCNRFT)
- Keywords
- frozen shoulder, radiofrequency ablation treatment, intra-articular injection
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular corticosteroid injection (IACI) groupOther
IACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy.
suprascapular nerve radiofrequency group (SCNRFT)Procedure or surgery
SCNRFT is a new choice for treatment of frozen shoulder. The suprascapular nerve is the nerve that is most commonly affected in the condition of a frozen shoulder and it is for this reason that the suprascapular nerve is directly targeted by pulsed radiofrequency treatment. As radiology techniques advance, ultrasound-guided SCNB becomes more popular. It provides a cost and time-effective way to "tag" the nerve accurately without injury to the nerves or vessels.
| Study group | Role | What they receive |
|---|---|---|
| suprascapular nerve radiofrequency group (SCNRFT) | Experimental | SCNRFT+intra-articular steroid and local anesthesic injection with physiotherapy. Suprascapular nerve RFT: Ultrasound-guided SCNRFT 42ºC, 360ms.
Ultrasound-guided intraarticular injection with 40mg triamcinolone+3 cc %0.5 bupivacaine.
Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening) Receives: Procedure: suprascapular nerve radiofrequency group (SCNRFT) |
| intra-articular corticosteroid injection (IACI) group | Active comparator | IACI with physiotherapy. Intra-articular steroid+local anesthesic injection: Receive intra-articular corticosteroid injection. Ultrasound-guided IACI with 3c.c. 0.5% bupivacaine and 40mg triamcinolone.
Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening) Receives: Other: intra-articular corticosteroid injection (IACI) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of The Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Measured: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Secondary outcomes (2)
The active ROM
The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.
Measured: Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Change of scores of the Shoulder Pain and Disability Index (SPADI)
The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
Measured: Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Aug 2021
- Primary completion10 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalı Alıyev, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778577
- Sponsor's protocol ID
- İ7-492-21
- Status last verified
- Jan 2025
- First submitted
- 25 Nov 2024
- Last updated
- 16 Jan 2025
- 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 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Ultrasound-guided Suprascapular Nerve Pulsed Radiofrequency Neuromodulation and Intra-articular Steroid Injection in Frozen Shoulder Treatment
- ClinicalTrials.gov ID
- NCT06778577
- Acronym / sponsor ID
- İ7-492-21
- Keywords
- frozen shoulder, radiofrequency ablation treatment, intra-articular injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 16 Jan 2025 (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 clinical study is to compare the effectiveness of suprascapular nerve pulsed radiofrequency and intra-articular steroid injection in patients with frozen shoulder (adhesive capsulitis). The main questions it aims to answer are:
- What is the effectiveness of intra-articular steroid injection in frozen shoulder?
- What is the effectiveness of suprascapular nerve radiofrequency in frozen shoulder?
- Should these two methods be used together in frozen shoulder?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suprascapular nerve radiofrequency group (SCNRFT) | Experimental | Procedure: suprascapular nerve radiofrequency group (SCNRFT)SCNRFT+intra-articular steroid and local anesthesic injection with physiotherapy. Suprascapular nerve RFT: Ultrasound-guided SCNRFT 42ºC, 360ms. Ultrasound-guided intraarticular injection with 40mg triamcinolone+3 cc %0.5 bupivacaine. Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening) |
| intra-articular corticosteroid injection (IACI) group | Active comparator | Other: intra-articular corticosteroid injection (IACI) groupIACI with physiotherapy. Intra-articular steroid+local anesthesic injection: Receive intra-articular corticosteroid injection. Ultrasound-guided IACI with 3c.c. 0.5% bupivacaine and 40mg triamcinolone. Physiotherapy: The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise. (stretching, mobilization and ROM exercise, and strengthening) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- unilateral side involvement.
- ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.
- duration of symptoms ≥3 months.
- age≥ 20year old.
- Patients with VAS ≥4 before the procedure
Key exclusion criteria (7 listed)
- ever received manipulation of the affected shoulder with/without anesthesia. systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)
- neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.
- pain or disorders of the cervical spine, elbow, wrist, or hand.
- a history of drug allergy to local or corticosteroids.
- Pregnancy or lactation.
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 |
|---|---|---|
| intra-articular corticosteroid injection (IACI) groupIACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy. | Other | intra-articular corticosteroid injection (IACI) group |
| suprascapular nerve radiofrequency group (SCNRFT)SCNRFT is a new choice for treatment of frozen shoulder. The suprascapular nerve is the nerve that is most commonly affected in the condition of a frozen shoulder and it is for this reason that the suprascapular nerve is directly targeted by pulsed radiofrequency treatment. As radiology techniques advance, ultrasound-guided SCNB becomes more popular. It provides a cost and time-effective way to "tag" the nerve accurately without injury to the nerves or vessels. | Procedure or surgery | suprascapular nerve radiofrequency group (SCNRFT) |
Primary outcome
Change of The Visual Analogue Scale (VAS)
Time frame: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
2 secondary outcomes
The active ROM
Time frame: Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Change of scores of the Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
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 16 Jan 2025.
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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 intra-articular corticosteroid injection (IACI) group and suprascapular nerve radiofrequency group (SCNRFT) in people with Frozen Shoulder and Radiofrequency Ablation Treatment, 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 7 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 16 Jan 2025. 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 of The Visual Analogue Scale (VAS) (time frame: baseline and at 4 weeks and 12 weeks after the beginning of the treatment.). 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 16 Jan 2025.