ClinicalTrials.gg
Not yet recruitingNCT07753759Updated Aug 7, 2026

Ultrasound-Guided Pulsed Radiofrequency Versus Phenol Neurolysis for Post-Stroke Hemiplegic Shoulder Pain

An interventional study of Pulsed radiofrequency neuromodulation and Ultrasound-guided phenol neurolysis in Post-Stroke Hemiplegic Shoulder Pain, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Shoulder Pain by Assiut University — 7 open to participants now, 7 under way, none of them phase 3. Shoulder Pain · Assiut University.

Started
2026
with 1 other
No phase
7 of 10
6 open now
Registered
9th of 10
by date

Among the 10 studies in Shoulder Pain by Assiut University, this one is one of 2 that started in 2026, is one of 7 with no phase, and was the 9th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

No phasethis study7 · 6 open
Observational2 · 1 open
Phase 31 · 0 open

By the year they started

First in 2017; this study’s year is marked. 2 started in 2026.

What they test

Size and results

Median enrollment 65 across the 8 interventional studies, 60 across the 2 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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 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.

03

Conditions studied

  • Post-Stroke Hemiplegic Shoulder Pain
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 ; 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

Exclusion criteria

Exclusion Criteria:

  • 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 to phenol, local anesthetic, antiseptic solution or other procedure-related medication.

Coagulopathy, 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Ultrasound-guided pulsed radiofrequency

    Procedure: Pulsed radiofrequency neuromodulation

  • Experimental
    Ultrasound-guided phenol neurolysis

    Other: Ultrasound-guided phenol neurolysis

Interventions

  • ProcedurePulsed radiofrequency neuromodulation

    Ultrasound-guided pulsed radiofrequency will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves

  • OtherUltrasound-guided phenol neurolysis

    Ultrasound-guided phenol injection will be applied to radicular branch of suprascapular, axillary and lat pectoral nerves

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3months

Secondary outcomes

  1. Pain intensity by VAS at 1 week, 1 month, and 6 months.

    Pain intensity by VAS at 1 week, 1 month, and 6 months.

    Time frame: 6 months

  2. Patient Global Impression of Change (1-7)at 1, 3, and 6 month

    Time frame: 6 months

  3. Functional outcomes using SPADI.

    Time frame: 6 months

  4. Neuromuscular/shoulder ultrasound findings, including bursitis, tendinopathy, effusion, subluxation or other relevant pathology when assessed.

    Time frame: 6 months

  5. 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

    Time frame: 6 months

  6. Analgesic/rescue medication consumption during follow-up.

    Time frame: 6 months

  7. Shoulder ROM measured by goniometer using a standardized method and side-positioning protocol. [14

    Time frame: 6 months

  8. Shoulder spasticity using MAS, with predefined target muscle groups documented at baseline. [12]

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 35385898 ↗
  • Karri 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 28537343 ↗
  • International 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.
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 349 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 12 months is close to that.

Counting every sponsor, half of 354 studies reached it within 11 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2026
First posted
Aug 7, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Feb 1, 2028
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07753759
Lead sponsor
Assiut University
Responsible party
Salwa Omar Mohamed (Assistant Lecturer in rheumatology, rehabilitation and physical medicine, Assiut University) — Principal investigator
First posted
Aug 7, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Aug 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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