Flossband therapy for shoulder pain in people with hemiplegia
Investigation of the Effectiveness of Flossing in Hemiplegic Patients With Shoulder Pain: Randomized Controlled Trial
NA · Uskudar University · NCT07261007
This test will see if adding flossband sessions to usual physical therapy reduces pain and improves shoulder motion, function, and sleep for adults (30–55) with chronic hemiplegic shoulder pain after stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | All |
| Sponsor | Uskudar University (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07261007 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study at the NRL Physical Therapy Center (Uskudar University, Istanbul) will assign participants to a control group receiving conventional physical therapy or an experimental group receiving conventional therapy plus flossband application. Treatments are delivered three times per week for six weeks with sessions lasting about 40–50 minutes. Pain will be measured with a Visual Analog Scale and sleep quality with the Pittsburgh Sleep Quality Scale, with assessments at baseline and after 6 weeks. The flossband application covers the shoulder region (deltoid, pectoralis major, subscapularis) applied in a spiral from proximal to distal.
Who should consider this trial
Good fit: Adults aged 30–55 who are at least six months post-stroke with hemiplegic shoulder pain (VAS ≥3), at least 90° active shoulder flexion and abduction, stable vital signs, and no major shoulder injury or significant spasticity.
Not a fit: Patients with acute inflammatory conditions, major orthopedic shoulder injuries (fracture, dislocation, rotator cuff tear), skin or circulatory problems preventing flossband use, latex allergy, or significant spasticity are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If effective, this low-cost, noninvasive adjunct could reduce pain, increase shoulder range of motion, and improve sleep and daily function for patients with hemiplegic shoulder pain.
How similar studies have performed: Tissue 'flossing' has shown small short-term benefits for pain and range of motion in some small and athletic-population studies, but evidence for post-stroke hemiplegic shoulder pain is limited and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Individuals with a clinical diagnosis of stroke * Individuals between the ages of 30 and 55 * Individuals experiencing hemiplegic shoulder pain (VAS ≥ 3) and/or limited joint movement * Individuals who have been at least 6 months post-stroke (chronic phase) * Individuals who have an active range of motion of at least 90° in shoulder flexion and abduction * Individuals with stable vital signs * Individuals who volunteer to participate in the study and who understand the purpose and process of the study and sign a written informed consent form Exclusion Criteria * Presence of serious orthopedic problems such as shoulder fractures, dislocations, or rotator cuff tears * Presence of skin lesions or circulatory disorders that may prevent flossband application * Spasticity in the affected arm (Modified Ashworth Scale ≥1) * Those with a latex allergy to the flossband material * Those with acute inflammatory conditions or acute pain
Where this trial is running
Istanbul
- Turkey — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Ömer ŞEVGİN
- Email: omer.sevgin@uskudar.edu.tr
- Phone: +905069787535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shoulder Pain, Hemiplegia