Shoulder PainNCT07261007

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

A study testing flossing in people with Shoulder Pain and Hemiplegia, run by Uskudar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 30 to 55 years
Conditions the study is for: Shoulder Pain, Hemiplegia
What is being tested?: flossing
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 3 Dec 2025to 10 May 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Turkey
Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions: Shoulder Pain, Hemiplegia
Being tested: control, flossing
Medical subject headings: Shoulder Pain, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07261007
Study group	Role	What they receive
control	Active comparator	conventional physiotherapy Receives: Other: control
flossing group	Experimental	conventional physiotherapy + flossing Receives: Other: flossing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 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".
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 202510 May 2026

First posted3 Dec 2025
Study start3 Dec 2025
Primary completion15 Mar 2026
Study completion10 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Shoulder PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07261007
Sponsor's protocol ID: Uskudar76
Status last verified: Jul 2026
First submitted: 21 Nov 2025
Last updated: 23 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Shoulder Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effectiveness of Flossing in Hemiplegic Patients With Shoulder Pain: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07261007
Acronym / sponsor ID: Uskudar76
Conditions: Shoulder Pain, Hemiplegia
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Uskudar UniversityUniversity, hospital or other
Study start: 3 Dec 2025 (actual)
Primary completion: 15 Mar 2026 (actual)
Study completion: 10 May 2026 (actual)
First posted: 3 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
control	Active comparator	Other: controlconventional physiotherapy
flossing group	Experimental	Other: flossingconventional physiotherapy + flossing

Who may qualify

Ages: 30 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
controlconventional physiotherapy applications; TENS, hotpack, ultrasound and exercise.	Other	control
flossingconventional 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.	Other	flossing group

Primary outcome

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.
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".

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Background: PubMed 37637031Kelly 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.
Background: PubMed 39877264Chen 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.
Background: PubMed 34084682Quiles-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.
Individual participant dataSharing planned: No

Related trials for Shoulder Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
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Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kübra UZUN study chair

Uskudar University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing flossing in people with Shoulder Pain and Hemiplegia, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder Pain and Disability Index (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07261007, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.