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CompletedNCT07261007Updated Jul 23, 2026

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

An interventional study of control and flossing in Shoulder Pain and Hemiplegia, sponsored by Uskudar University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 30 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

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

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
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Study 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.

Read the detailed description

This study will be conducted at the NRL Physical Therapy Center. Participants must sign an informed consent form before starting the study. Participants will be randomly assigned to two groups: a control and an experimental group. A Visual Analog Scale will be used to assess pain. A score of 0 represents no pain, and a score of 10 represents unbearable pain. The Pittsburgh Sleep Quality Scale will be used to assess sleep quality. Assessments will be made before starting treatment and at the end of treatment after 6 weeks. The experimental group will receive conventional physical therapy and flossband application. This group will receive conventional physical therapy and flossband application three sessions per week, each session lasting approximately 40-50 minutes, for 6 weeks. The flossband application will cover the area around the shoulder joint (specifically the deltoid, pectoralis major, and subscapularis line). A spiral bandage will be applied starting from the mid-distal portion of the deltoid muscle, working distally from proximal to distal.

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Conditions studied

  • Shoulder Pain
  • Hemiplegia
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In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Uskudar University is the lead sponsor of 164 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

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

Study arms

  • Active comparator
    control

    conventional physiotherapy

    Other: control

  • Experimental
    flossing group

    conventional physiotherapy + flossing

    Other: flossing

Interventions

  • Othercontrol

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

  • Otherflossing

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 weeks

  2. 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".

    Time frame: 6 weeks

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Study locations

1 site
  • Turkey
    Istanbul, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 37637031 ↗
  • 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. PubMed 39877264 ↗
  • 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. PubMed 34084682 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07261007
Lead sponsor
Uskudar University
Responsible party
Doç.Dr.Ömer Şevgin (Assoc.Prof.Dr., Uskudar University) — Principal investigator
First posted
Dec 3, 2025
Start date
Dec 3, 2025
Primary completion
Mar 15, 2026
Completion
May 10, 2026
Last update
Jul 23, 2026

Study contacts

Kübra UZUN
study chair · Uskudar University

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 completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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