Hemiplegic Shoulder PainNCT06473389
Efficacy of Suprascapular Radiofrequency Ablation in Hemiplegic Shoulder Pain
A study testing Suprascapular nerve pulse radiofrequency ablation, Suprascapular Nerve Block Group and Steroid Group in people with Hemiplegic Shoulder Pain, run by Yunus Burak Bayır at 1 site in Turkey (Türkiye).
Trial summary
Stroke, one of the most important causes of disability and death in the world, is an acute focal deficit of the central system caused by vascular origin such as cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- Suprascapular nerve pulse radiofrequency ablation, Suprascapular Nerve Block Group and Steroid Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Those who were diagnosed with hemorrhagic or ischemic stroke at least 3 months ago
- Patients with shoulder pain with VAS > 5 severity after hemiplegia
- Those who agree to participate with a consent document (their own or their foster family)
Who cannot join
- Those who did not provide a consent document
- Those under 18 years of age
- Those who cannot cooperate
- Severely aphasic patients
- Patients with shoulder pain VAS >5 severity
- Patients who have undergone interventional procedures such as RF, suprascapular nerve blockade, steroid injection, etc. for the shoulder area in the last 3 months
Show all 11Show fewer
- Patients with bleeding diathesis
- Those with a history of surgery or radiotherapy in the shoulder area
- Those who had shoulder complaints before the stroke
- Patients with pacemakers
- Patients with MMT Score <24
Trial locations and contacts
1 site in 1 country.
Fatma BALLI UZ, specialist contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, Yenimahalle, 06170
yunus burak bayır, specialist, 5058083317
About this study
Official title: Efficacy of Suprascapular Radiofrequency Ablation Versus USG-guided Suprascapular Nerve Blockade and Intra-articular Steroid Injections in Hemiplegic Shoulder Pain: A Three-blind Randomized Controlled Study.
Stroke, one of the most important causes of disability and death in the world, is an acute focal deficit of the central system caused by vascular origin such as cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. Hemiplegic shoulder pain, which is one of the most common complications after stroke, is an important problem affecting extremity rehabilitation. Although there are many factors thought to cause haemiplegic shoulder pain, there is still controversy about its treatment. Although there are many treatment strategies for this complication such as analgesics, antispasmotics, local corticosteroid injections, suprascapular nerve blockade, physical therapy modalities and exercise therapy, sometimes very resistant cases are also seen. For the treatment of persistent haemiplegic shoulder pain unresponsive to conventional treatment modalities, intra-articular injection of corticosteroids into the shoulder joint is commonly used, but its palliative effect has only a relatively short duration.Corticosteroids may also have adverse effects such as allergic reactions, rash, hyperglycaemia, menstrual disorders and adrenal suppression. Suprascapular nerve block is another option to relieve haemiplegic shoulder pain. The suprascapular nerve provides 70% of the sensory innervation of the shoulder joint. Thus, blocking pain transmission through the SS provides effective control of haemiplegic shoulder pain. However, the efficacy of suprascapular nerve block varies according to the study population and depends on the therapeutic modality to which it is compared. In addition, the effect of suprascapular nerve blockade may be limited due to the short duration of action of local anaesthetic agents. Neurolysis may cause permanent paralysis of the supraspinatus and infraspinatus muscles. For this reason, a deconstructive method is not preferred. Pulse RF applications, which is a non-deconstructive, neuromodulatory method, may be preferred in this regard. So far, there are very few studies investigating the efficacy of intra-articular steroid injection, suprascapular block and pulse RF in hemiplegic shoulder pain separately, but there is no study investigating the efficacy of Pulse RF treatment against other treatment methods together. In this study, investigator's aim was to compare the efficacy of suprascapular pulse radiofrequency against USG-guided suprascapular nerve block and intra-articular steroid injections in hemiplegic shoulder pain.
Read the detailed description
This study was designed as a prospective, triple-blind randomised controlled study. Patients hospitalised in the stroke clinic of our hospital and diagnosed with haemorrhagic or ischaemic stroke will be included in our study. Sample size was calculated using the statistical power analysis programme G*Power 3.1.9.4 for Windows. Based on the study by Allen et al. evaluating the efficacy of suprascapular nerve block in post-stroke shoulder pain, the minimum number of patients required to achieve a significant change of 20 mm in VAS assessment before and after treatment (with a 5% Type 1 and 20% Type 2 margin of error, 80% working power and 95% confidence interval) was found to be 23 (total 69 patients) for each group. Considering the possibility of 20% loss during the study, it was decided to include at least 28 (total 84) patients for each group. Patients who met the inclusion criteria and completed the 'Informed Volunteer Consent Forum' will be randomised into three groups of 28 patients as the first group RF Group (RFG), the second group Suprascapular Nerve Blockage Group (SSBG) and the third group Intraarticular Steroid Group (SG) with the 'Research Randomizer' computer programme.Patients, the physician performing the assessment and the physiotherapist treating the patient will be blinded to which procedure is performed. A blinded investigator will perform baseline assessments of the participants before the injection. While Transcutaneous Electrical Nerve Stimulation (TENS), hotpack and exercise treatments, which are frequently used in the treatment of hemiplegic shoulder pain, were performed in all patients; in addition to the patients selected to the PRF group with the 'Research Randomizer' computer programme, pulse RF application with TOP-TLG10 STP generator at 2 Hz, 20 ms and 45 V for 2 minutes at 2 Hz, 20 ms and 45 V at a maximum temperature of 42 degrees once to the suprascapular nerve under US guidance, 5 ml of 1% ml betamethasone + 2% lidocaine 2 ml, 0. 9% Serum Physiological 2 ml mixture will be applied to the suprascapular block group and intra-articular steroid application with a mixture of 2% lidocaine 2 ml, 0.9% Serum Physiological 2 ml and 1 ml betamethasone 5 mg will be applied to the steroid group. All procedures will be performed with a portable ultrasonography system with a 12 MHz linear probe and exercises will be performed under the supervision of a physiotherapist. The treatment of the patients will be organised as a total of 20 sessions for 4 weeks, 5 days a week, first TENS and hotpack, then exercise. 15 minutes of hotpack, 15 minutes of TENS will be applied, followed by 30 minutes of upper extremity exercises.
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- Suprascapular nerve pulse radiofrequency ablation, Suprascapular Nerve Block Group, Steroid Group
- Keywords
- Hemiplegic shoulder, stroke, pain, radiofrequency, suprascapular nerve, corticosteroid, injection
- Medical subject headings
- Stroke, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular nerve pulse radiofrequency ablationProcedure or surgery
Pulse RF application will be applied to the suprascapular nerve once under US guidance with a TOP-TLG10 STP generator at a maximum temperature of 42 degrees, 2 Hz, 20 ms and 45 V for 2 minutes.
Suprascapular Nerve Block GroupProcedure or surgery
Suprascapular block will be applied once with a mixture consisting of 5 ml (1 ml betamethasone, 2% lidocaine 2 ml, 0.9% saline 2 ml).
Steroid GroupProcedure or surgery
Intra-articular steroid application will be made with a mixture consisting of 5 ml (2 ml of 2% lidocaine, 2 ml of 0.9% saline and 1 ml of betamethasone 5 mg).
| Study group | Role | What they receive |
|---|---|---|
| Pulse Radiofrequency Ablation | Active comparator | Pulse RF application will be applied to the suprascapular nerve once under US guidance with a TOP-TLG10 STP generator at a maximum temperature of 42 degrees, 2 Hz, 20 ms and 45 V for 2 minutes. Receives: Procedure: Suprascapular nerve pulse radiofrequency ablation |
| Suprascapular Nerve Block Injection | Active comparator | Suprascapular block will be performed once with a mixture consisting of 5 ml (1 ml betamethasone, 2% lidocaine 2 ml, 0.9% saline 2 ml). Receives: Procedure: Suprascapular Nerve Block Group |
| Intra-articular Steroid İnjection | Active comparator | Intra-articular steroid will be performed once with a mixture consisting of 5 ml (2 ml lidocaine 2 ml, 0.9% saline 2 ml and 1 ml betamethasone 5 mg). Receives: Procedure: Steroid Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Shoulder pain.The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.
Measured: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
painful angle of the shoulder
painful angle of the shoulder
Measured: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Secondary outcomes (4)
range of motion
range of motion (ROM; flexion, abduction, internal and external rotation)
Measured: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Goal Attainment Scale (GAS)
Goal Attainment Scale (GAS) during upper-body dressingIn the functional evaluation, the GAS during upper-body dressing was used to assess the effect of shoulder pain on functional capacity. GAS is a mathematical tech- nique for quantifying the achievement (or otherwise) of goals set, and it can be used in rehabilitation (7). According to this scale, pain during upper extremity dressing was evaluated (-2: severe pain, -1: moderate pain, 0: mild pain, +1: pain at the end of movement, and +2: painless motion. The highest indicating the best score.
Measured: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Modified Barthel Index
Physical competence and independence in daily living activities will be evaluatedIn the modified Barthel index, the level of functional independence in a total of 10 activities such as transfer, movement, stairs, nutrition, dressing, personal care, bathing, sitting and rising to the toilet, urinary and faecal incontinence is evaluated. The total score varies between 0-100. Zero score indicates complete dependence and 100 score indicates complete independence.
Measured: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
SPADI
Shoulder Pain and Disability Index scoreIt is a 13-item questionnaire categorised into pain and activity limitation. The score ranges from 0-100.The highest indicating the best score.
Measured: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Aug 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- 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
- This study was designed as a prospective, triple-blind, randomised controlled study. Patients hospitalised in the stroke clinic of our hospital and diagnosed with haemorrhagic or ischaemic stroke will be included in our study.Patients will be randomised into three groups of 28 patients as the first group RF Group (RFG), the second group Suprascapular Nerve Blockade Group (SSBG) and the third group Intraarticular Steroid Group (SG) with the 'Research Randomizer' computer program. The treatments of the patients will be organised as a total of 20 sessions for 4 weeks, 5 days a week, first TENS and hotpack, then exercise. 15 minutes of hotpack, 15 minutes of TENS will be applied, followed by 30 minutes of upper extremity exercises.The degree of maximum passive ROM measurements of the shoulder, the degree of passive ROM, Visual Analogue Scale (VAS), Shoulder Pain and Disability Index score (SPADI), Goal Attainment Scale (GAS), Modified Barthel Index at baseline, 1st, 4th, 12th weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunus Burak Bayır
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yunus Burak Bayır, Ankara Etlik City Hospital
- Investigators
- Damla CANKURTARAN, assoc. prof., Study chair, Ankara Etlik City HospitalEbru KARACA UMAY, prof., Study chair, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473389
- Sponsor's protocol ID
- Suprascapular Rf
- Status last verified
- Sep 2024
- First submitted
- 12 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alanbay E, Aras B, Kesikburun S, Kizilirmak S, Yasar E, Tan AK. Effectiveness of Suprascapular Nerve Pulsed Radiofrequency Treatment for Hemiplegic Shoulder Pain: A Randomized-Controlled Trial. Pain Physician. 2020 Jun;23(3):245-252.
PubMed 32517390Chiu YH, Chang KV, Wu WT, Hsu PC, Ozcakar L. Comparative Effectiveness of Injection Therapies for Hemiplegic Shoulder Pain in Stroke: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2021 Aug 10;14(8):788. doi: 10.3390/ph14080788.
PubMed 34451885Kim TH, Chang MC. Comparison of the effectiveness of pulsed radiofrequency of the suprascapular nerve and intra-articular corticosteroid injection for hemiplegic shoulder pain management. J Integr Neurosci. 2021 Sep 30;20(3):687-693. doi: 10.31083/j.jin2003073.
PubMed 34645102
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Suprascapular Radiofrequency Ablation Versus USG-guided Suprascapular Nerve Blockade and Intra-articular Steroid Injections in Hemiplegic Shoulder Pain: A Three-blind Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06473389
- Acronym / sponsor ID
- Suprascapular Rf
- Conditions
- Hemiplegic Shoulder Pain
- Keywords
- Hemiplegic shoulder, stroke, pain, radiofrequency, suprascapular nerve, corticosteroid, injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Yunus Burak BayırOther government
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 25 Jun 2024 (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.
Stroke, one of the most important causes of disability and death in the world, is an acute focal deficit of the central system caused by vascular origin such as cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. Hemiplegic shoulder pain, which is one of the most common complications after stroke, is an important problem affecting extremity rehabilitation. Although there are many factors thought to cause haemiplegic shoulder pain, there is still controversy about its treatment. Although there are many treatment strategies for this complication such as analgesics, antispasmotics, local corticosteroid injections, suprascapular nerve blockade, physical therapy modalities and exercise therapy, sometimes very resistant cases are also seen. For the treatment of persistent haemiplegic shoulder pain unresponsive to conventional treatment modalities, intra-articular injection of corticosteroids into the shoulder joint is commonly used, but its palliative effect has only a relatively short duration.Corticosteroids may also have adverse effects such as allergic reactions, rash, hyperglycaemia, menstrual disorders and adrenal suppression. Suprascapular nerve block is another option to relieve haemiplegic shoulder pain. The suprascapular nerve provides 70% of the sensory innervation of the shoulder joint. Thus, blocking pain transmission through the SS provides effective control of haemiplegic shoulder pain. However, the efficacy of suprascapular nerve block varies according to the study population and depends on the therapeutic modality to which it is compared. In addition, the effect of suprascapular nerve blockade may be limited due to the short duration of action of local anaesthetic agents. Neurolysis may cause permanent paralysis of the supraspinatus and infraspinatus muscles. For this reason, a deconstructive method is not preferred. Pulse RF applications, which is a non-deconstructive, neuromodulatory method, may be preferred in this regard. So far, there are very few studies investigating the efficacy of intra-articular steroid injection, suprascapular block and pulse RF in hemiplegic shoulder pain separately, but there is no study investigating the efficacy of Pulse RF treatment against other treatment methods together. In this study, investigator's aim was to compare the efficacy of suprascapular pulse radiofrequency against USG-guided suprascapular nerve block and intra-articular steroid injections in hemiplegic shoulder pain.
Detailed description
This study was designed as a prospective, triple-blind randomised controlled study. Patients hospitalised in the stroke clinic of our hospital and diagnosed with haemorrhagic or ischaemic stroke will be included in our study. Sample size was calculated using the statistical power analysis programme G*Power 3.1.9.4 for Windows. Based on the study by Allen et al. evaluating the efficacy of suprascapular nerve block in post-stroke shoulder pain, the minimum number of patients required to achieve a significant change of 20 mm in VAS assessment before and after treatment (with a 5% Type 1 and 20% Type 2 margin of error, 80% working power and 95% confidence interval) was found to be 23 (total 69 patients) for each group. Considering the possibility of 20% loss during the study, it was decided to include at least 28 (total 84) patients for each group. Patients who met the inclusion criteria and completed the 'Informed Volunteer Consent Forum' will be randomised into three groups of 28 patients as the first group RF Group (RFG), the second group Suprascapular Nerve Blockage Group (SSBG) and the third group Intraarticular Steroid Group (SG) with the 'Research Randomizer' computer programme.Patients, the physician performing the assessment and the physiotherapist treating the patient will be blinded to which procedure is performed. A blinded investigator will perform baseline assessments of the participants before the injection. While Transcutaneous Electrical Nerve Stimulation (TENS), hotpack and exercise treatments, which are frequently used in the treatment of hemiplegic shoulder pain, were performed in all patients; in addition to the patients selected to the PRF group with the 'Research Randomizer' computer programme, pulse RF application with TOP-TLG10 STP generator at 2 Hz, 20 ms and 45 V for 2 minutes at 2 Hz, 20 ms and 45 V at a maximum temperature of 42 degrees once to the suprascapular nerve under US guidance, 5 ml of 1% ml betamethasone + 2% lidocaine 2 ml, 0. 9% Serum Physiological 2 ml mixture will be applied to the suprascapular block group and intra-articular steroid application with a mixture of 2% lidocaine 2 ml, 0.9% Serum Physiological 2 ml and 1 ml betamethasone 5 mg will be applied to the steroid group. All procedures will be performed with a portable ultrasonography system with a 12 MHz linear probe and exercises will be performed under the supervision of a physiotherapist. The treatment of the patients will be organised as a total of 20 sessions for 4 weeks, 5 days a week, first TENS and hotpack, then exercise. 15 minutes of hotpack, 15 minutes of TENS will be applied, followed by 30 minutes of upper extremity exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This study was designed as a prospective, triple-blind, randomised controlled study. Patients hospitalised in the stroke clinic of our hospital and diagnosed with haemorrhagic or ischaemic stroke will be included in our study.Patients will be randomised into three groups of 28 patients as the first group RF Group (RFG), the second group Suprascapular Nerve Blockade Group (SSBG) and the third group Intraarticular Steroid Group (SG) with the 'Research Randomizer' computer program. The treatments of the patients will be organised as a total of 20 sessions for 4 weeks, 5 days a week, first TENS and hotpack, then exercise. 15 minutes of hotpack, 15 minutes of TENS will be applied, followed by 30 minutes of upper extremity exercises.The degree of maximum passive ROM measurements of the shoulder, the degree of passive ROM, Visual Analogue Scale (VAS), Shoulder Pain and Disability Index score (SPADI), Goal Attainment Scale (GAS), Modified Barthel Index at baseline, 1st, 4th, 12th weeks.
| Arm | Type | Receives |
|---|---|---|
| Pulse Radiofrequency Ablation | Active comparator | Procedure: Suprascapular nerve pulse radiofrequency ablationPulse RF application will be applied to the suprascapular nerve once under US guidance with a TOP-TLG10 STP generator at a maximum temperature of 42 degrees, 2 Hz, 20 ms and 45 V for 2 minutes. |
| Suprascapular Nerve Block Injection | Active comparator | Procedure: Suprascapular Nerve Block GroupSuprascapular block will be performed once with a mixture consisting of 5 ml (1 ml betamethasone, 2% lidocaine 2 ml, 0.9% saline 2 ml). |
| Intra-articular Steroid İnjection | Active comparator | Procedure: Steroid GroupIntra-articular steroid will be performed once with a mixture consisting of 5 ml (2 ml lidocaine 2 ml, 0.9% saline 2 ml and 1 ml betamethasone 5 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years old
- Those who were diagnosed with hemorrhagic or ischemic stroke at least 3 months ago
- Patients with shoulder pain with VAS > 5 severity after hemiplegia
- Those who agree to participate with a consent document (their own or their foster family)
Key exclusion criteria (11 listed)
- Those who did not provide a consent document
- Those under 18 years of age
- Those who cannot cooperate
- Severely aphasic patients
- Patients with shoulder pain VAS >5 severity
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 |
|---|---|---|
| Suprascapular nerve pulse radiofrequency ablationPulse RF application will be applied to the suprascapular nerve once under US guidance with a TOP-TLG10 STP generator at a maximum temperature of 42 degrees, 2 Hz, 20 ms and 45 V for 2 minutes. | Procedure or surgery | Pulse Radiofrequency Ablation |
| Suprascapular Nerve Block GroupSuprascapular block will be applied once with a mixture consisting of 5 ml (1 ml betamethasone, 2% lidocaine 2 ml, 0.9% saline 2 ml). | Procedure or surgery | Suprascapular Nerve Block Injection |
| Steroid GroupIntra-articular steroid application will be made with a mixture consisting of 5 ml (2 ml of 2% lidocaine, 2 ml of 0.9% saline and 1 ml of betamethasone 5 mg). | Procedure or surgery | Intra-articular Steroid İnjection |
Primary outcome
Visual Analog Scale (VAS)
Time frame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Shoulder pain.The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.
painful angle of the shoulder
Time frame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
painful angle of the shoulder
4 secondary outcomes
range of motion
Time frame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Goal Attainment Scale (GAS)
Time frame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Modified Barthel Index
Time frame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
SPADI
Time frame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 32517390Alanbay E, Aras B, Kesikburun S, Kizilirmak S, Yasar E, Tan AK. Effectiveness of Suprascapular Nerve Pulsed Radiofrequency Treatment for Hemiplegic Shoulder Pain: A Randomized-Controlled Trial. Pain Physician. 2020 Jun;23(3):245-252.
- Results publication: PubMed 34451885Chiu YH, Chang KV, Wu WT, Hsu PC, Ozcakar L. Comparative Effectiveness of Injection Therapies for Hemiplegic Shoulder Pain in Stroke: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2021 Aug 10;14(8):788. doi: 10.3390/ph14080788.
- Results publication: PubMed 34645102Kim TH, Chang MC. Comparison of the effectiveness of pulsed radiofrequency of the suprascapular nerve and intra-articular corticosteroid injection for hemiplegic shoulder pain management. J Integr Neurosci. 2021 Sep 30;20(3):687-693. doi: 10.31083/j.jin2003073.
- Individual participant dataSharing planned: No
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Stroke
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.
Fatma BALLI UZ, specialist contact
Damla CANKURTARAN, assoc. prof. study chair
Ankara Etlik City Hospital
Ebru KARACA UMAY, prof. study chair
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprascapular nerve pulse radiofrequency ablation, Suprascapular Nerve Block Group and Steroid Group in people with Hemiplegic Shoulder Pain, run by Yunus Burak Bayır 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YUNUS BURAK BAYIR, specialist (05058083317, yunusburakbayir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: This evaluation will be made and recorded at the beginning, at the 1st, 4th and 12th weeks after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473389, which also lists 3 linked publications.
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 19 Sep 2024.