Focal vibration therapy for shoulder pain after stroke
Tests focal vibration added to rehabilitation in adults with long-term post-stroke shoulder pain.
Key facts
- Who runs it
- University of Foggia
- Where
- Foggia, ItalySee the site
- Trial code
- Registry title
- Focal Vibration Therapy in Post-stroke Shoulder Pain
- Status
- Not yet recruiting
- People taking part
- 60 people, planned
- Started
- 1 Apr 2026
- Expected to end
- 1 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Multimodal Focal Vibration Therapy (FVT)
- Standard Rehabilitation Program
- Record updated
- 7 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a stroke at least 6 months ago and now have shoulder pain on the weak side. It tests focal vibration therapy added to standard rehabilitation.
- Age
- 18 to 80 years
- Sex
- Women and men can join.
- Disease stage
- Stroke (ischemic or hemorrhagic) confirmed by CT or MRI, at least 6 months ago, with hemiplegic shoulder pain (NRS ≥ 4).
- Earlier treatment
- No botulinum toxin injections in the shoulder or upper limb muscles in the last 3-4 months. No other experimental or non-conventional physical therapies for shoulder pain during the study.
Main reasons for not taking part
- Severe cognitive or language problems that prevent understanding the study or reporting pain
- Severe neglect, apraxia or disorders of consciousness
- Shoulder disease on the affected side not caused by the stroke, or prior shoulder surgery
- Fixed shoulder contractures or severe joint deformities
- Botulinum toxin injections to the shoulder or upper limb muscles within the last 3-4 months
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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 take part
- 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)
- 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
- 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
- Fixed shoulder contractures or severe joint deformities limiting passive range of motion and preventing standardized assessment
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
- Università degli Studi di FoggiaFoggia, ItalyNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Active Focal Vibration Therapy + Standard RehabilitationTreatment being tested
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.
Treatment: Multimodal Focal Vibration Therapy (FVT) and Standard Rehabilitation Program
- Sham Focal Vibration Therapy + Standard RehabilitationSham treatment, for comparison
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.
Treatment: Standard Rehabilitation Program
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Focal Vibrational Therapy in Reducing Post-stroke Shoulder Pain: a Double-blind, Randomized Controlled Trial
- Plain-language title
- Focal vibration therapy for shoulder pain after strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07513753, who can take part
- Record updated
- 7 April 2026