Investigation of the Effectiveness of Flossing in Hemiplegic Patients With Shoulder Pain

NCT07261007 | Recruiting

• 1 other identifier: Uskudar76
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to contribute to clinical practice by investigating the effectiveness of flossband application on range of motion, functionality, pain and sleep quality in hemiplegic patients with shoulder pain.

Conditions

Shoulder Pain; Hemiplegia

Outcome Measures

Primary Outcomes (2)

• Shoulder Pain and Disability Index

  It's a self-reported questionnaire consisting of two subgroups: pain and shoulder disability level. It consists of 13 questions: five for pain and eight for shoulder disability level. In the pain section, a visual analog scale score of 0 indicates no pain and 10 indicates the most severe pain. In the shoulder disability level section, a score of 0 indicates no difficulty and 10 indicates very difficult (I need help). Scoring is performed by measuring the distance between the individual's chosen point and 0 using a ruler and recording the score in centimeters. The total score is calculated by averaging the two subgroup scores. A higher score indicates shoulder pain and functional impairment.

  8 weeks

• The Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality".

  8 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

conventional physiotherapy

Other: control

flossing group

EXPERIMENTAL

conventional physiotherapy + flossing

Other: flossing

Interventions

control OTHER

conventional physiotherapy applications; TENS, hotpack, ultrasound and exercise.

control

flossing OTHER

conventional physiotherapy applications; TENS, hotpack, ultrasound and exercise. The floss band application will cover the area around the shoulder joint (specifically the deltoid, pectoralis major, and subscapularis). The bandage will be applied in a spiral pattern, starting from the mid-distal portion of the deltoid muscle and working distally to proximally. It will be applied with approximately 50% tension.

flossing group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Turkey

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Kelly CF, Oliveri Z, Saladino J, Senatore J, Kamat A, Zarour J, Douris PC. The Acute Effect of Tissue Flossing on Pain, Function, and Perception of Movement: A Pilot Study. Int J Exerc Sci. 2023 Jul 1;16(3):855-865. doi: 10.70252/OKAO5505. eCollection 2023.

  PMID: 37637031 BACKGROUND

• Chen J, Wang Q, Zhao Z, Song Q, Zhao P, Wang D. Acute effects of tissue flossing on boxers with chronic knee pain. Front Bioeng Biotechnol. 2025 Jan 14;12:1508054. doi: 10.3389/fbioe.2024.1508054. eCollection 2024.

  PMID: 39877264 BACKGROUND

• Quiles-Sanchez LV, Baroutas I, Kyriakos G, Gravvanis N, Georgakopoulou VE, Trakas N, Damaskos C, Garmpi A, Garmpis N, Antoniou V, Farmaki P, Patsouras A, Voutyritsa E, Diamantis E. Medical Flossing and the Pilates Method: Their Effectiveness on the Strength, Endurance, and Functionality of Healthy Individuals. Cureus. 2021 Apr 29;13(4):e14758. doi: 10.7759/cureus.14758.

  PMID: 34084682 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Hemiplegia

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Nervous System Diseases

Study Officials

• Kübra UZUN

  Uskudar University

  STUDY CHAIR

Central Study Contacts

Ömer ŞEVGİN

CONTACT

+905069787535; omer.sevgin@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Dr.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 3, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)