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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07261007
Enrollment
40
Registered
2025-12-03
Start date
2025-12-03
Completion date
2026-02-01
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain, Hemiplegia

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.

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.

Interventions

OTHERcontrol

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

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.

Sponsors

Uskudar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain and Disability Index8 weeksIt'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.
The Pittsburgh Sleep Quality Index8 weeksPittsburgh 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖmer ŞEVGİN
omer.sevgin@uskudar.edu.tr+905069787535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026