StrokeVIBRA-HSPNCT07513753
Focal Vibration Therapy in Post-stroke Shoulder Pain
A study testing Multimodal Focal Vibration Therapy (FVT) and Standard Rehabilitation Program in people with Stroke and Hemiplegic Shoulder Pain, run by University of Foggia at 1 site in Italy.
Trial summary
Hemiplegic Shoulder Pain (HSP) is a common and disabling complication after stroke, negatively affecting upper limb function, participation in rehabilitation, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hemiplegic Shoulder Pain, Chronic Stroke Survivors
- What is being tested?
- Multimodal Focal Vibration Therapy (FVT) and Standard Rehabilitation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2026to 1 Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Ischemic or hemorrhagic stroke confirmed by CT or MRI
- Chronic post-stroke phase (≥ 6 months from event)
- Presence of hemiplegic shoulder pain (NRS ≥ 4)
- Preserved cognitive function sufficient to provide informed consent
Who cannot join
- Severe cognitive impairment or language deficits (e.g., severe aphasia) that prevent understanding of study procedures or reliable reporting of pain (e.g., inability to complete NRS or questionnaires).
- Severe neglect, apraxia, or disorders of consciousness that interfere with participation in rehabilitation or outcome assessments.
- Pre-existing shoulder pathology of the affected side unrelated to stroke (e.g., full-thickness rotator cuff tear, advanced glenohumeral osteoarthritis, inflammatory arthritis, prior shoulder surgery).
- Fixed shoulder contractures or severe joint deformities limiting passive range of motion and preventing standardized assessment.
- Botulinum toxin injections to shoulder upper limb muscles within the last 3-4 months prior to enrollment .
- Current treatment with other experimental or non-conventional physical therapies for shoulder pain during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Focal Vibrational Therapy in Reducing Post-stroke Shoulder Pain: a Double-blind, Randomized Controlled Trial
Hemiplegic Shoulder Pain (HSP) is a common and disabling complication after stroke, negatively affecting upper limb function, participation in rehabilitation, and quality of life. Despite the widespread use of conservative and physical therapies, evidence supporting the efficacy of specific non-invasive neuromodulation techniques remains limited.
Focal Vibration Therapy (FVT) is a non-invasive physical modality that delivers localized mechanical vibration to targeted muscles or tendons and may modulate pain, muscle tone, and proprioception through frequency-dependent mechanisms.
This randomized controlled trial aims to evaluate the efficacy of a multimodal FVT protocol, in addition to standard rehabilitation, compared with a sham intervention plus standard rehabilitation, in reducing pain in patients with chronic post-stroke Hemiplegic Shoulder Pain.
Read the detailed description
Hemiplegic Shoulder Pain (HSP) is a frequent and disabling sequela of stroke, with reported incidence rates ranging from 30% to 65% within the first six months after stroke onset. This variability reflects differences in diagnostic definitions and heterogeneity among studied populations. The underlying pathophysiology of HSP is multifactorial, involving musculoskeletal alterations (e.g., glenohumeral subluxation), abnormal nociceptive processing and central sensitization, and spasticity-related impairments, particularly affecting shoulder adductor and internal rotator muscles.
HSP significantly interferes with post-stroke recovery by reducing upper limb motor performance and functional use, impairing participation in rehabilitation programs, and worsening quality of life. Although early and multidisciplinary management is recommended, available therapeutic approaches remain heterogeneous and include positioning strategies, manual therapy, pharmacological treatments, nerve blocks, botulinum toxin injections, dry needling, robotic-assisted therapy, and neuromodulation techniques.
Physical therapeutic modalities are commonly used in rehabilitation settings due to their non-invasive nature and potential analgesic and functional benefits. However, evidence regarding their specific effectiveness in the treatment of HSP is inconsistent, and existing reviews often include heterogeneous interventions or focus on invasive approaches, leaving uncertainty about the role of targeted physical neuromodulation.
Focal Vibration Therapy (FVT) is an emerging physical modality that applies localized mechano-sonic stimulation to muscle bellies or tendon insertions. Its effects are frequency-dependent and include modulation of nociceptive input through spinal gate control mechanisms at low-to-medium frequencies (approximately 35-50 Hz), modulation of muscle tone and proprioception through stimulation of Ia afferent fibers and induction of the tonic vibration reflex at intermediate frequencies (around 100 Hz), and modulation of deep pain perception through activation of Pacinian corpuscles at higher frequencies (approximately 200 Hz).
Given the multifactorial nature of HSP and the limitations of current conservative treatments, there is a need to investigate structured intervention protocols integrating advanced physical modalities with standard rehabilitation. This randomized controlled trial will compare a multimodal FVT protocol, delivered in addition to standard rehabilitation, with a sham intervention plus standard rehabilitation in patients with chronic post-stroke HSP. The study will assess changes in pain intensity as the primary outcome, along with secondary outcomes related to shoulder function, range of motion, spasticity, quality of life, persistence of treatment effects, and safety of the intervention.
- Conditions
- Stroke, Hemiplegic Shoulder Pain, Chronic Stroke Survivors
- Being tested
- Multimodal Focal Vibration Therapy (FVT), Standard Rehabilitation Program
- Keywords
- Focal vibration Therapy, stroke, pain, Hemiplegic Shoulder Pain
- Medical subject headings
- Stroke, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Focal Vibration Therapy (FVT)Device
Participants in the experimental group will receive multimodal Focal Vibration Therapy (FVT) delivered using a medical vibration device, in addition to standard post-stroke shoulder rehabilitation. FVT will be applied to selected peri-scapular and shoulder muscles involved in pain generation and motor impairment, according to a standardized protocol. Each treatment session consists of two integrated phases.
Physiokinesitherapy Phase (30 minutes):
Participants will undergo a standardized rehabilitation protocol targeting recovery of the hemiplegic shoulder.
Focal Vibration Therapy Phase (25 minutes):
Four dome-shaped transducers will be applied directly to the skin over the muscle bellies of Pectoralis Major, Infraspinatus, Middle Deltoid, and Upper Trapezius. The device will deliver a pre-programmed sequence of vibrations consisting of:
- 5 minutes at 35 Hz for superficial analgesia
- 10 minutes at 100 Hz for muscle tone reduction
- 10 minutes at 200 Hz for deep analgesia
Standard Rehabilitation ProgramOther
All participants will undergo a standardized post-stroke shoulder rehabilitation program, including passive, active-assisted, and active exercises aimed at pain reduction, range of motion recovery, and functional improvement of the affected upper limb. Each session will consist of the same two phases as the experimental group.
Physiokinesitherapy Phase (30 minutes):
Identical to that administered in the experimental group.
Sham Procedure Phase (25 minutes):
Four transducers will be positioned on the same shoulder muscle sites as in the experimental group but connected to inactive outputs of the device, delivering no therapeutic vibration. To maintain participant blinding, an additional active transducer will be applied to a distant site, delivering perceptible vibration. Participants will be informed that the device acts through a systemic reflex stimulation mechanism. Device-related noise and tatactile stimulation on the contralateral limb will function as a sensory distractor.
| Study group | Role | What they receive |
|---|---|---|
| Active Focal Vibration Therapy + Standard Rehabilitation | Experimental | Participants allocated to the experimental group will receive an integrated treatment consisting of a standardized physiokinesitherapy program followed by active multimodal focal vibration therapy applied to shoulder and peri-scapular muscles involved in hemiplegic shoulder pain. Receives: Device: Multimodal Focal Vibration Therapy (FVT); Other: Standard Rehabilitation Program |
| Sham Focal Vibration Therapy + Standard Rehabilitation | Sham comparator | Participants allocated to the control group will receive the same standardized physiokinesitherapy program followed by a sham focal vibration procedure identical in duration and application setting, but without delivery of effective vibratory stimulation. Receives: Other: Standard Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Assessed by Numerical Rating Scale (NRS)
Change from baseline in pain intensity measured using the Numerical Rating Scale (NRS, 0-10) comparing multimodal Focal Vibration Therapy (FVT) plus standard rehabilitation versus standard rehabilitation plus sham procedure in patients with chronic post-stroke hemiplegic shoulder pain.
Pain intensity will be assessed under three standardized conditions to reflect the multidimensional nature of hemiplegic shoulder pain:
- Pain at rest (spontaneous pain)
- Pain during passive range of motion (pROM) in shoulder flexion and abduction
- Pain during active or active-assisted range of motion (aROM) The primary endpoint will be expressed as mean change (Δ score) between T0 and T1.
Measured: From baseline (Day 0) to the Day 15 (end of treatment)
Secondary outcomes (6)
Change in Shoulder Function and Disability (SPADI)
Change from baseline in total score and subscale scores (Pain and Disability) of the Shoulder Pain and Disability Index (SPADI: range 0-100 where higher scores indicate greater pain and disability), comparing the two study groups across post-treatment and follow-up time points.
Measured: Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up
Change in Glenohumeral Range of Motion (ROM) (degrees)
Change from baseline in active and passive glenohumeral joint range of motion (ROM), including flexion, abduction, and external rotation, measured in degrees using a standardized universal goniometer. Higher values indicate improved joint mobility.
Measured: Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up
Change in Upper Limb Spasticity (Modified Ashworth Scale)
Change from baseline in muscle tone assessed by the Modified Ashworth Scale (MAS; range 0-4, where higher scores indicate greater spasticity) in shoulder internal rotators/adductors (Pectoralis Major, Subscapularis)
Measured: Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up
Change in Health-Related Quality of Life (SF-12)
Change from baseline in physical (PCS) and mental (MCS) health composite scores assessed using the Short Form-12 Health Survey (SF-12; higher scores indicate better health status).
Measured: Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up
Maintenance of Treatment Effect on Pain (NRS) at Follow-up
Between-group differences in pain intensity measured by the Numerical Rating Scale (NRS, 0-10) at 1, 3, and 6 months after completion of treatment, to assess persistence of treatment effects over time.
Measured: 1 month, 3 months, and 6 months after end of treatment
Incidence of Adverse Events (AEs) and Device-Related Adverse Events (ADEs)
Number and severity of adverse events (AEs) and device-related adverse events (ADEs) recorded during the study period. Events will be classified according to their relationship to the intervention.
Measured: From baseline through 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Parallel-group randomized controlled trial. Participants are randomly assigned in a 1:1 ratio to receive either active multimodal focal vibration therapy combined with standard physiokinesitherapy or sham focal vibration therapy combined with standard physiokinesitherapy. Both groups follow the same treatment schedule and duration.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spina Stefania, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513753
- Sponsor's protocol ID
- FoggiaFisiatria_01
- Acronym
- VIBRA-HSP
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
PubMed 5320816Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
PubMed 11188601Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
PubMed 27145936Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.
PubMed 22507444Calabro RS, Naro A, Russo M, Milardi D, Leo A, Filoni S, Trinchera A, Bramanti P. Is two better than one? Muscle vibration plus robotic rehabilitation to improve upper limb spasticity and function: A pilot randomized controlled trial. PLoS One. 2017 Oct 3;12(10):e0185936. doi: 10.1371/journal.pone.0185936. eCollection 2017.
PubMed 28973024Chae J, Mascarenhas D, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Poststroke shoulder pain: its relationship to motor impairment, activity limitation, and quality of life. Arch Phys Med Rehabil. 2007 Mar;88(3):298-301. doi: 10.1016/j.apmr.2006.12.007.
PubMed 17321820Gamble GE, Barberan E, Bowsher D, Tyrrell PJ, Jones AK. Post stroke shoulder pain: more common than previously realized. Eur J Pain. 2000;4(3):313-5. doi: 10.1053/eujp.2000.0192.
PubMed 10985876Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
PubMed 24842220Marconi B, Filippi GM, Koch G, Giacobbe V, Pecchioli C, Versace V, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair. 2011 Jan;25(1):48-60. doi: 10.1177/1545968310376757. Epub 2010 Sep 12.
PubMed 20834043Costantino C, Galuppo L, Romiti D. Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2017 Feb;53(1):32-40. doi: 10.23736/S1973-9087.16.04211-8. Epub 2016 Sep 6.
PubMed 27598342Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
PubMed 33275908
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Focal Vibrational Therapy in Reducing Post-stroke Shoulder Pain: a Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07513753
- Acronym / sponsor ID
- VIBRA-HSP / FoggiaFisiatria_01
- Conditions
- Stroke, Hemiplegic Shoulder Pain, Chronic Stroke Survivors
- Keywords
- Focal vibration Therapy, stroke, pain, Hemiplegic Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 Apr 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.
Hemiplegic Shoulder Pain (HSP) is a common and disabling complication after stroke, negatively affecting upper limb function, participation in rehabilitation, and quality of life. Despite the widespread use of conservative and physical therapies, evidence supporting the efficacy of specific non-invasive neuromodulation techniques remains limited.
Focal Vibration Therapy (FVT) is a non-invasive physical modality that delivers localized mechanical vibration to targeted muscles or tendons and may modulate pain, muscle tone, and proprioception through frequency-dependent mechanisms.
This randomized controlled trial aims to evaluate the efficacy of a multimodal FVT protocol, in addition to standard rehabilitation, compared with a sham intervention plus standard rehabilitation, in reducing pain in patients with chronic post-stroke Hemiplegic Shoulder Pain.
Detailed description
Hemiplegic Shoulder Pain (HSP) is a frequent and disabling sequela of stroke, with reported incidence rates ranging from 30% to 65% within the first six months after stroke onset. This variability reflects differences in diagnostic definitions and heterogeneity among studied populations. The underlying pathophysiology of HSP is multifactorial, involving musculoskeletal alterations (e.g., glenohumeral subluxation), abnormal nociceptive processing and central sensitization, and spasticity-related impairments, particularly affecting shoulder adductor and internal rotator muscles.
HSP significantly interferes with post-stroke recovery by reducing upper limb motor performance and functional use, impairing participation in rehabilitation programs, and worsening quality of life. Although early and multidisciplinary management is recommended, available therapeutic approaches remain heterogeneous and include positioning strategies, manual therapy, pharmacological treatments, nerve blocks, botulinum toxin injections, dry needling, robotic-assisted therapy, and neuromodulation techniques.
Physical therapeutic modalities are commonly used in rehabilitation settings due to their non-invasive nature and potential analgesic and functional benefits. However, evidence regarding their specific effectiveness in the treatment of HSP is inconsistent, and existing reviews often include heterogeneous interventions or focus on invasive approaches, leaving uncertainty about the role of targeted physical neuromodulation.
Focal Vibration Therapy (FVT) is an emerging physical modality that applies localized mechano-sonic stimulation to muscle bellies or tendon insertions. Its effects are frequency-dependent and include modulation of nociceptive input through spinal gate control mechanisms at low-to-medium frequencies (approximately 35-50 Hz), modulation of muscle tone and proprioception through stimulation of Ia afferent fibers and induction of the tonic vibration reflex at intermediate frequencies (around 100 Hz), and modulation of deep pain perception through activation of Pacinian corpuscles at higher frequencies (approximately 200 Hz).
Given the multifactorial nature of HSP and the limitations of current conservative treatments, there is a need to investigate structured intervention protocols integrating advanced physical modalities with standard rehabilitation. This randomized controlled trial will compare a multimodal FVT protocol, delivered in addition to standard rehabilitation, with a sham intervention plus standard rehabilitation in patients with chronic post-stroke HSP. The study will assess changes in pain intensity as the primary outcome, along with secondary outcomes related to shoulder function, range of motion, spasticity, quality of life, persistence of treatment effects, and safety of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group randomized controlled trial. Participants are randomly assigned in a 1:1 ratio to receive either active multimodal focal vibration therapy combined with standard physiokinesitherapy or sham focal vibration therapy combined with standard physiokinesitherapy. Both groups follow the same treatment schedule and duration.
| Arm | Type | Receives |
|---|---|---|
| Active Focal Vibration Therapy + Standard Rehabilitation | Experimental | Device: Multimodal Focal Vibration Therapy (FVT), Other: Standard Rehabilitation ProgramParticipants allocated to the experimental group will receive an integrated treatment consisting of a standardized physiokinesitherapy program followed by active multimodal focal vibration therapy applied to shoulder and peri-scapular muscles involved in hemiplegic shoulder pain. |
| Sham Focal Vibration Therapy + Standard Rehabilitation | Sham comparator | Other: Standard Rehabilitation ProgramParticipants allocated to the control group will receive the same standardized physiokinesitherapy program followed by a sham focal vibration procedure identical in duration and application setting, but without delivery of effective vibratory stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Ischemic or hemorrhagic stroke confirmed by CT or MRI
- Chronic post-stroke phase (≥ 6 months from event)
- Presence of hemiplegic shoulder pain (NRS ≥ 4)
- Preserved cognitive function sufficient to provide informed consent
Key exclusion criteria (6 listed)
- Severe cognitive impairment or language deficits (e.g., severe aphasia) that prevent understanding of study procedures or reliable reporting of pain (e.g., inability to complete NRS or questionnaires).
- Severe neglect, apraxia, or disorders of consciousness that interfere with participation in rehabilitation or outcome assessments.
- Pre-existing shoulder pathology of the affected side unrelated to stroke (e.g., full-thickness rotator cuff tear, advanced glenohumeral osteoarthritis, inflammatory arthritis, prior shoulder surgery).
- Fixed shoulder contractures or severe joint deformities limiting passive range of motion and preventing standardized assessment.
- Botulinum toxin injections to shoulder upper limb muscles within the last 3-4 months prior to enrollment .
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 |
|---|---|---|
| Multimodal Focal Vibration Therapy (FVT)Participants in the experimental group will receive multimodal Focal Vibration Therapy (FVT) delivered using a medical vibration device, in addition to standard post-stroke shoulder rehabilitation. FVT will be applied to selected peri-scapular and shoulder muscles involved in pain generation and motor impairment, according to a standardized protocol. Each treatment session consists of two integrated phases. Physiokinesitherapy Phase (30 minutes): Participants will undergo a standardized rehabilitation protocol targeting recovery of the hemiplegic shoulder. Focal Vibration Therapy Phase (25 minutes): Four dome-shaped transducers will be applied directly to the skin over the muscle bellies of Pectoralis Major, Infraspinatus, Middle Deltoid, and Upper Trapezius. The device will deliver a pre-programmed sequence of vibrations consisting of: * 5 minutes at 35 Hz for superficial analgesia * 10 minutes at 100 Hz for muscle tone reduction * 10 minutes at 200 Hz for deep analgesia | Device | Active Focal Vibration Therapy + Standard Rehabilitation |
| Standard Rehabilitation ProgramAll participants will undergo a standardized post-stroke shoulder rehabilitation program, including passive, active-assisted, and active exercises aimed at pain reduction, range of motion recovery, and functional improvement of the affected upper limb. Each session will consist of the same two phases as the experimental group. Physiokinesitherapy Phase (30 minutes): Identical to that administered in the experimental group. Sham Procedure Phase (25 minutes): Four transducers will be positioned on the same shoulder muscle sites as in the experimental group but connected to inactive outputs of the device, delivering no therapeutic vibration. To maintain participant blinding, an additional active transducer will be applied to a distant site, delivering perceptible vibration. Participants will be informed that the device acts through a systemic reflex stimulation mechanism. Device-related noise and tatactile stimulation on the contralateral limb will function as a sensory distractor. | Other | Active Focal Vibration Therapy + Standard Rehabilitation, Sham Focal Vibration Therapy + Standard Rehabilitation |
Primary outcome
Change in Pain Intensity Assessed by Numerical Rating Scale (NRS)
Time frame: From baseline (Day 0) to the Day 15 (end of treatment)
Change from baseline in pain intensity measured using the Numerical Rating Scale (NRS, 0-10) comparing multimodal Focal Vibration Therapy (FVT) plus standard rehabilitation versus standard rehabilitation plus sham procedure in patients with chronic post-stroke hemiplegic shoulder pain. Pain intensity will be assessed under three standardized conditions to reflect the multidimensional nature of hemiplegic shoulder pain: * Pain at rest (spontaneous pain) * Pain during passive range of motion (pROM) in shoulder flexion and abduction * Pain during active or active-assisted range of motion (aROM) The primary endpoint will be expressed as mean change (Δ score) between T0 and T1.
6 secondary outcomes
Change in Shoulder Function and Disability (SPADI)
Time frame: Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up
Change in Glenohumeral Range of Motion (ROM) (degrees)
Time frame: Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up
Change in Upper Limb Spasticity (Modified Ashworth Scale)
Time frame: Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up
Change in Health-Related Quality of Life (SF-12)
Time frame: Baseline (Day 0), Day 15 (end of treatment), and at 1, 3, and 6 months follow-up
Maintenance of Treatment Effect on Pain (NRS) at Follow-up
Time frame: 1 month, 3 months, and 6 months after end of treatment
Incidence of Adverse Events (AEs) and Device-Related Adverse Events (ADEs)
Time frame: From baseline through 6 months follow-up
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 Apr 2026.
- Background: PubMed 5320816Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
- Background: PubMed 11188601Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
- Background: PubMed 27145936Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
- Background: PubMed 22507444Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.
- Background: PubMed 28973024Calabro RS, Naro A, Russo M, Milardi D, Leo A, Filoni S, Trinchera A, Bramanti P. Is two better than one? Muscle vibration plus robotic rehabilitation to improve upper limb spasticity and function: A pilot randomized controlled trial. PLoS One. 2017 Oct 3;12(10):e0185936. doi: 10.1371/journal.pone.0185936. eCollection 2017.
- Background: PubMed 17321820Chae J, Mascarenhas D, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Poststroke shoulder pain: its relationship to motor impairment, activity limitation, and quality of life. Arch Phys Med Rehabil. 2007 Mar;88(3):298-301. doi: 10.1016/j.apmr.2006.12.007.
- Background: PubMed 10985876Gamble GE, Barberan E, Bowsher D, Tyrrell PJ, Jones AK. Post stroke shoulder pain: more common than previously realized. Eur J Pain. 2000;4(3):313-5. doi: 10.1053/eujp.2000.0192.
- Background: PubMed 24842220Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.
- Background: PubMed 20834043Marconi B, Filippi GM, Koch G, Giacobbe V, Pecchioli C, Versace V, Camerota F, Saraceni VM, Caltagirone C. Long-term effects on cortical excitability and motor recovery induced by repeated muscle vibration in chronic stroke patients. Neurorehabil Neural Repair. 2011 Jan;25(1):48-60. doi: 10.1177/1545968310376757. Epub 2010 Sep 12.
- Background: PubMed 27598342Costantino C, Galuppo L, Romiti D. Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2017 Feb;53(1):32-40. doi: 10.23736/S1973-9087.16.04211-8. Epub 2016 Sep 6.
- Background: PubMed 33275908Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
- Individual participant dataSharing planned: No
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Focal Vibration Therapy (FVT) and Standard Rehabilitation Program in people with Stroke and Hemiplegic Shoulder Pain, run by University of Foggia at 1 site in Italy.
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 6 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 Apr 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 Italy. 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. Some participants in this study may receive a placebo. 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 Pain Intensity Assessed by Numerical Rating Scale (NRS) (time frame: From baseline (Day 0) to the Day 15 (end of treatment)). 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 NCT07513753, which also lists 11 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 Apr 2026.