Post-Stroke Hemiplegic Shoulder PainNCT07753759
Ultrasound-Guided Pulsed Radiofrequency Versus Phenol Neurolysis for Post-Stroke Hemiplegic Shoulder Pain
A study testing Pulsed radiofrequency neuromodulation and Ultrasound-guided phenol neurolysis in people with Post-Stroke Hemiplegic Shoulder Pain, run by Assiut University.
Trial summary
Post-stroke hemiplegic shoulder pain is a common complication that negatively affects upper limb function and quality of life. This randomized controlled trial aims to compare the efficacy and safety of ultrasound-guided pulsed radiofrequency neuromodulation versus ultrasound-guided phenol neurolysis targeting the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Stroke Hemiplegic Shoulder Pain
- What is being tested?
- Pulsed radiofrequency neuromodulation and Ultrasound-guided phenol neurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 years or older. History of ischemic or hemorrhagic stroke confirmed clinically and/or by neuroimaging when available.
- Post-stroke shoulder pain on the hemiplegic side with VAS pain intensity >=4/10 during rest, passive movement or functional use.
- Spasticity of target shoulder-girdle muscles with MAS score >=2. Stable medical condition allowing outpatient or inpatient interventional procedure.
- Ability to provide written informed consent; if the patient has a communication impairment, consent will follow institutional ethics-approved procedures involving legally authorized representatives when appropriate.
- Expected ability to attend scheduled follow-up visits through 6 months
Who cannot join
- Previous radiofrequency treatment or phenol neurolysis to the affected shoulder within the previous 6 months.
- Botulinum toxin injection to the target shoulder muscles within the previous 3-6 months.
- Shoulder fracture, dislocation or rotator cuff tear requiring surgery. Active infection at the injection site. Known allergy or contraindication to phenol, local anesthetic, antiseptic solution or other procedure-related medication.
- Coagulopathy, platelet disorder or anticoagulant/antiplatelet treatment that cannot be safely managed according to local anesthesia/interventional-pain policy.
- Severe uncontrolled medical illness, unstable cardiopulmonary disease, uncontrolled diabetes with active infection risk, or any condition judged by investigators to increase procedural risk.
- Severe cognitive, behavioral, or communication impairment preventing reliable pain/outcome assessment unless a validated caregiver-assisted assessment approach is approved by the ethics committee.
- Pregnancy or lactation, when applicable, because of procedural medication exposure and safety monitoring requirements.
- Concurrent participation in another interventional trial that may affect shoulder pain, tone or function.
About this study
Official title: Ultrasound-Guided Pulsed Radiofrequency Neuromodulation Versus Ultrasound -Guided Phenol Neurolysis in Post-Stroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial
Post-stroke hemiplegic shoulder pain is a common complication that negatively affects upper limb function and quality of life. This randomized controlled trial aims to compare the efficacy and safety of ultrasound-guided pulsed radiofrequency neuromodulation versus ultrasound-guided phenol neurolysis targeting the suprascapular, axillary, and lateral pectoral nerves in patients with post-stroke hemiplegic shoulder pain. The primary outcome is pain reduction, while secondary outcomes include shoulder function, spasticity, range of motion, quality of life, analgesic consumption, and adverse events during follow-up.
Read the detailed description
Hemiplegic shoulder pain (HSP) is a common complication following stroke. It may lead to withdrawal from rehabilitation programs, reduced upper-limb movement and poorer functional recovery; therefore, timely pain control is relevant to rehabilitation participation and long-term outcome. [1] A systematic review reported wide variation in incidence and prevalence; pooled/meta-analytic estimates included incidence ranges around 10-22% and prevalence ranges around 22-47%, while individual studies varied more widely because of differences in timing, definitions and clinical settings. Risk factors include increased tone, impaired motor function, sensory impairment, shoulder subluxation, abnormal shoulder examination, hemispastical neglect and prior shoulder pain. [1,2] The cause of post-stroke HSP is often multifactorial. The mechanisms can be grouped into: (a) impaired motor control and tone changes; (b) soft-tissue lesions and (c) altered peripheral and central nervous activity, Because these mechanisms may overlap in the same patient, baseline clinical and ultrasound phenotyping will be used to document the dominant pain/spasticity pattern and to exclude structural shoulder pathology requiring surgical management. [1,3,4] Central sensitization, defined as increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input, may contribute to persistent HSP. [4] Pulsed radiofrequency delivers radiofrequency current in intermittent pulses consisting of short periods of electrical stimulation, typically 20 ms, followed by longer silent phases, approximately 480 ms. This intermittent delivery allows heat dissipation and keeps target tissue temperature below approximately 42 degrees Celsius, thereby reducing the risk of thermal nerve injury. For this reason, the intervention is described in this enhanced protocol as PRF rather than conventional thermal radiofrequency ablation. This correction improves technical accuracy because the submitted synopsis described a PRF technique rather than destructive thermal ablation. [5] PRF stimulation may reduce pain through long-term depression of C-fiber-mediated spinal sensitization and several neuromodulatory effects on inflammatory and descending inhibitory pathways. The exact mechanism remains elucidated; therefore, the study will measure both pain and function rather than assuming a single mechanism of benefit. [5,6] Phenol is a neurolytic agent used to manage focal spasticity. Immediately after injection, phenol may produce a transient local anesthetic effect by reversibly blocking nerve conduction. At neurolytic concentrations, commonly around 5-6%, phenol causes protein denaturation with segmental demyelination, axonal degeneration, and Wallerian degeneration of exposed nerve fibers, interrupting nerve conduction and reducing overactivity. Because phenol can cause dysesthesia, pain, inflammation, hypotension or unintended motor/sensory effects, the protocol specifies ultrasound guidance, aspiration before injection, limited per-nerve volumes according to institutional SOP, post-procedure monitoring, and structured AE recording.
- Conditions
- Post-Stroke Hemiplegic Shoulder Pain
- Being tested
- Pulsed radiofrequency neuromodulation, Ultrasound-guided phenol neurolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed radiofrequency neuromodulationProcedure or surgery
Ultrasound-guided pulsed radiofrequency will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
Ultrasound-guided phenol neurolysisOther
Ultrasound-guided phenol injection will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided pulsed radiofrequency | Experimental | Not described Receives: Procedure: Pulsed radiofrequency neuromodulation |
| Ultrasound-guided phenol neurolysis | Experimental | Not described Receives: Other: Ultrasound-guided phenol neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shoulder pain intensity measured from baseline to 3 months
Change in shoulder pain intensity measured by 0-10 cm/point VAS from baseline to 3 months. The 3-month endpoint is selected as the primary endpoint because it is clinically meaningful for rehabilitation planning and allows comparison of medium-term response between neuromodulatory PRF and neurolytic phenol treatment.
Measured: 3months
Secondary outcomes (8)
Pain intensity by VAS at 1 week, 1 month, and 6 months.
Pain intensity by VAS at 1 week, 1 month, and 6 months.
Measured: 6 months
Patient Global Impression of Change (1-7)at 1, 3, and 6 month
Measured: 6 months
Functional outcomes using SPADI.
Measured: 6 months
Neuromuscular/shoulder ultrasound findings, including bursitis, tendinopathy, effusion, subluxation or other relevant pathology when assessed.
Measured: 6 months
Technical success
Technical success is defined as successful ultrasound-guided identification of all predefined target nerves, correct needle placement, and complete delivery of the assigned intervention to all target nerves. The outcome will be reported as the proportion of participants in whom all criteria are achieved
Measured: 6 months
Analgesic/rescue medication consumption during follow-up.
Measured: 6 months
Shoulder ROM measured by goniometer using a standardized method and side-positioning protocol. [14
Measured: 6 months
Shoulder spasticity using MAS, with predefined target muscle groups documented at baseline. [12]
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Feb 2028 (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 Post-Stroke Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- More trials run by Assiut 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 will be randomly assigned to one of two parallel groups to receive either ultrasound-guided pulsed radiofrequency neuromodulation or ultrasound-guided phenol neurolysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Omar Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753759
- Sponsor's protocol ID
- ASU-HSP-PRF-PHENOL-1
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park D, Chang MC. The mechanism of action of pulsed radiofrequency in reducing pain: a narrative review. J Yeungnam Med Sci. 2022 Jul;39(3):200-205. doi: 10.12701/jyms.2022.00101. Epub 2022 Apr 7.
PubMed 35385898Karri J, Mas MF, Francisco GE, Li S. Practice patterns for spasticity management with phenol neurolysis. J Rehabil Med. 2017 Jun 28;49(6):482-488. doi: 10.2340/16501977-2239.
PubMed 28537343International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3). Final version. Adopted 06 January 2025.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Pulsed Radiofrequency Neuromodulation Versus Ultrasound -Guided Phenol Neurolysis in Post-Stroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07753759
- Acronym / sponsor ID
- ASU-HSP-PRF-PHENOL-1
- Conditions
- Post-Stroke Hemiplegic Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 7 Aug 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.
Post-stroke hemiplegic shoulder pain is a common complication that negatively affects upper limb function and quality of life. This randomized controlled trial aims to compare the efficacy and safety of ultrasound-guided pulsed radiofrequency neuromodulation versus ultrasound-guided phenol neurolysis targeting the suprascapular, axillary, and lateral pectoral nerves in patients with post-stroke hemiplegic shoulder pain. The primary outcome is pain reduction, while secondary outcomes include shoulder function, spasticity, range of motion, quality of life, analgesic consumption, and adverse events during follow-up.
Detailed description
Hemiplegic shoulder pain (HSP) is a common complication following stroke. It may lead to withdrawal from rehabilitation programs, reduced upper-limb movement and poorer functional recovery; therefore, timely pain control is relevant to rehabilitation participation and long-term outcome. [1] A systematic review reported wide variation in incidence and prevalence; pooled/meta-analytic estimates included incidence ranges around 10-22% and prevalence ranges around 22-47%, while individual studies varied more widely because of differences in timing, definitions and clinical settings. Risk factors include increased tone, impaired motor function, sensory impairment, shoulder subluxation, abnormal shoulder examination, hemispastical neglect and prior shoulder pain. [1,2] The cause of post-stroke HSP is often multifactorial. The mechanisms can be grouped into: (a) impaired motor control and tone changes; (b) soft-tissue lesions and (c) altered peripheral and central nervous activity, Because these mechanisms may overlap in the same patient, baseline clinical and ultrasound phenotyping will be used to document the dominant pain/spasticity pattern and to exclude structural shoulder pathology requiring surgical management. [1,3,4] Central sensitization, defined as increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input, may contribute to persistent HSP. [4] Pulsed radiofrequency delivers radiofrequency current in intermittent pulses consisting of short periods of electrical stimulation, typically 20 ms, followed by longer silent phases, approximately 480 ms. This intermittent delivery allows heat dissipation and keeps target tissue temperature below approximately 42 degrees Celsius, thereby reducing the risk of thermal nerve injury. For this reason, the intervention is described in this enhanced protocol as PRF rather than conventional thermal radiofrequency ablation. This correction improves technical accuracy because the submitted synopsis described a PRF technique rather than destructive thermal ablation. [5] PRF stimulation may reduce pain through long-term depression of C-fiber-mediated spinal sensitization and several neuromodulatory effects on inflammatory and descending inhibitory pathways. The exact mechanism remains elucidated; therefore, the study will measure both pain and function rather than assuming a single mechanism of benefit. [5,6] Phenol is a neurolytic agent used to manage focal spasticity. Immediately after injection, phenol may produce a transient local anesthetic effect by reversibly blocking nerve conduction. At neurolytic concentrations, commonly around 5-6%, phenol causes protein denaturation with segmental demyelination, axonal degeneration, and Wallerian degeneration of exposed nerve fibers, interrupting nerve conduction and reducing overactivity. Because phenol can cause dysesthesia, pain, inflammation, hypotension or unintended motor/sensory effects, the protocol specifies ultrasound guidance, aspiration before injection, limited per-nerve volumes according to institutional SOP, post-procedure monitoring, and structured AE recording.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive either ultrasound-guided pulsed radiofrequency neuromodulation or ultrasound-guided phenol neurolysis.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided pulsed radiofrequency | Experimental | Procedure: Pulsed radiofrequency neuromodulation |
| Ultrasound-guided phenol neurolysis | Experimental | Other: Ultrasound-guided phenol neurolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older. History of ischemic or hemorrhagic stroke confirmed clinically and/or by neuroimaging when available.
- Post-stroke shoulder pain on the hemiplegic side with VAS pain intensity >=4/10 during rest, passive movement or functional use.
- Spasticity of target shoulder-girdle muscles with MAS score >=2. Stable medical condition allowing outpatient or inpatient interventional procedure.
- Ability to provide written informed consent; if the patient has a communication impairment, consent will follow institutional ethics-approved procedures involving legally authorized representatives when appropriate.
- Expected ability to attend scheduled follow-up visits through 6 months
Key exclusion criteria (8 listed)
- Previous radiofrequency treatment or phenol neurolysis to the affected shoulder within the previous 6 months.
- Botulinum toxin injection to the target shoulder muscles within the previous 3-6 months.
- Shoulder fracture, dislocation or rotator cuff tear requiring surgery. Active infection at the injection site. Known allergy or contraindication to phenol, local anesthetic, antiseptic solution or other procedure-related medication.
- Coagulopathy, platelet disorder or anticoagulant/antiplatelet treatment that cannot be safely managed according to local anesthesia/interventional-pain policy.
- Severe uncontrolled medical illness, unstable cardiopulmonary disease, uncontrolled diabetes with active infection risk, or any condition judged by investigators to increase procedural risk.
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 |
|---|---|---|
| Pulsed radiofrequency neuromodulationUltrasound-guided pulsed radiofrequency will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves | Procedure or surgery | Ultrasound-guided pulsed radiofrequency |
| Ultrasound-guided phenol neurolysisUltrasound-guided phenol injection will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves | Other | Ultrasound-guided phenol neurolysis |
Primary outcome
Change in shoulder pain intensity measured from baseline to 3 months
Time frame: 3months
Change in shoulder pain intensity measured by 0-10 cm/point VAS from baseline to 3 months. The 3-month endpoint is selected as the primary endpoint because it is clinically meaningful for rehabilitation planning and allows comparison of medium-term response between neuromodulatory PRF and neurolytic phenol treatment.
8 secondary outcomes
Pain intensity by VAS at 1 week, 1 month, and 6 months.
Time frame: 6 months
Patient Global Impression of Change (1-7)at 1, 3, and 6 month
Time frame: 6 months
Functional outcomes using SPADI.
Time frame: 6 months
Neuromuscular/shoulder ultrasound findings, including bursitis, tendinopathy, effusion, subluxation or other relevant pathology when assessed.
Time frame: 6 months
Technical success
Time frame: 6 months
Analgesic/rescue medication consumption during follow-up.
Time frame: 6 months
Shoulder ROM measured by goniometer using a standardized method and side-positioning protocol. [14
Time frame: 6 months
Shoulder spasticity using MAS, with predefined target muscle groups documented at baseline. [12]
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 35385898Park D, Chang MC. The mechanism of action of pulsed radiofrequency in reducing pain: a narrative review. J Yeungnam Med Sci. 2022 Jul;39(3):200-205. doi: 10.12701/jyms.2022.00101. Epub 2022 Apr 7.
- Background: PubMed 28537343Karri J, Mas MF, Francisco GE, Li S. Practice patterns for spasticity management with phenol neurolysis. J Rehabil Med. 2017 Jun 28;49(6):482-488. doi: 10.2340/16501977-2239.
- BackgroundInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3). Final version. Adopted 06 January 2025.
Related trials for Post-Stroke Hemiplegic Shoulder Pain
Not yet recruiting
Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke
Hemiplegic Shoulder Pain
Not yet recruiting
Focal Vibration Therapy in Post-stroke Shoulder Pain
Stroke, Hemiplegic Shoulder Pain
Active, not recruiting
Postural Decoding for Post-Stroke Shoulder Pain: A RCT.
Stroke; Sequelae
Enrolling by invitationObservational study
The Effect of Shoulder Problems on Balance in Hemiplegic Patients
Hemiplegia, 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed radiofrequency neuromodulation and Ultrasound-guided phenol neurolysis in people with Post-Stroke Hemiplegic Shoulder Pain, run by Assiut University.
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 8 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 shoulder pain intensity measured from baseline to 3 months (time frame: 3months). 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 NCT07753759, 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 7 Aug 2026.