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NCT Number: NCT07261007

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

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.

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Key information

Conditions

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

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turkey

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

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

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.

Primary outcomes

  1. Shoulder Pain and Disability Index

    Time frame: 6 weeks

    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.

  2. The Pittsburgh Sleep Quality Index

    Time frame: 6 weeks

    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".

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

Investigation of the Effectiveness of Flossing in Hemiplegic Patients With Shoulder Pain: Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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