Pain IntensityNCT06389747
Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness
A study testing BFR technique in people with Pain Intensity, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Intensity
- What is being tested?
- BFR technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Apr 2024to 15 Jun 2024
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals between the ages of 18-35 (who have not participated in any resistance training program for at least 6 months)
Who cannot join
- Having a previous musculoskeletal system injury
- Having a condition that prevents resistance exercise
- Having cardiovascular disease
- Using medication for blood pressure control
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Gamze Aydın
Istanbul, 34940
Gamze Aydın, gmzetsn@gmail.com
- Recruiting
Istanbul Okan University
Istanbul, 34944
Gamze Aydın, PhD, +905377600256, gmzetsn@gmail.com
About this study
Official title: Effect of Blood Flow Restriction Technique on Pain, Muscle Tone and Strength in Delayed Muscle Soreness
The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned.
Read the detailed description
All participants will be taken into the DOMS creation protocol. Participants will then be divided into 80% intensity BFR and 20% intensity Blood Flow Restriction technique (BFR) groups and will be included in an exercise protocol accompanied by BFR application.
- Conditions
- Pain Intensity
- Being tested
- BFR technique
- Keywords
- pain, muscle strength, muscle tonus
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR techniqueOther
For BFR application, Airbands brand, wireless, automatic training cuffs will be used. During application, it will be ensured that the device module faces forward and the cuff will be fixed in the correct position by wrapping the band around the metal ring. There will be a space between the skin and the cuff that can fit two fingers. The cuff will then be paired via Bluetooth with the Airbands app installed on the phone. BFR cuffs will be placed proximal to the biceps brachii muscle and pressure will be applied. The cuff will be inflated to automatically detect limb pressure. BFR application with 80% pressure to one group of participants and 20% pressure to the other group will be applied simultaneously with the exercise.
| Study group | Role | What they receive |
|---|---|---|
| %80 BFR group | Active comparator | %80 intensity BFR technique will be applied to this group. Receives: Other: BFR technique |
| %20 BFR group | Active comparator | %20 intensity BFR technique will be applied to this group. Receives: Other: BFR technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
it will be used for assessment of pain intensity, It is scored between 0-10, and higher scores indicate that the situation is getting worse.
Measured: 2 months
myoton
it will be used for assessment of muscle tonus and biomechanic properties, scores are changin according to different parameters.
Measured: 2 months
dynamometer
it will be used for assessment of myscle strength, lower scores indicate that the situation is getting worse.
Measured: 2 months
dolorimeter
it will be used for assessment of pain thresold pressure, lower scores indicate that the situation is getting worse.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start24 Apr 2024
- Primary completion28 May 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain IntensityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Aydin, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389747
- Sponsor's protocol ID
- OU
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction Technique on Pain, Muscle Tone and Strength in Delayed Muscle Soreness
- ClinicalTrials.gov ID
- NCT06389747
- Acronym / sponsor ID
- OU
- Conditions
- Pain Intensity
- Keywords
- pain, muscle strength, muscle tonus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 28 May 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 29 Apr 2024 (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.
The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned.
Detailed description
All participants will be taken into the DOMS creation protocol. Participants will then be divided into 80% intensity BFR and 20% intensity Blood Flow Restriction technique (BFR) groups and will be included in an exercise protocol accompanied by BFR application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| %80 BFR group | Active comparator | Other: BFR technique%80 intensity BFR technique will be applied to this group. |
| %20 BFR group | Active comparator | Other: BFR technique%20 intensity BFR technique will be applied to this group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals between the ages of 18-35 (who have not participated in any resistance training program for at least 6 months)
Key exclusion criteria (4 listed)
- Having a previous musculoskeletal system injury
- Having a condition that prevents resistance exercise
- Having cardiovascular disease
- Using medication for blood pressure control
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 |
|---|---|---|
| BFR techniqueFor BFR application, Airbands brand, wireless, automatic training cuffs will be used. During application, it will be ensured that the device module faces forward and the cuff will be fixed in the correct position by wrapping the band around the metal ring. There will be a space between the skin and the cuff that can fit two fingers. The cuff will then be paired via Bluetooth with the Airbands app installed on the phone. BFR cuffs will be placed proximal to the biceps brachii muscle and pressure will be applied. The cuff will be inflated to automatically detect limb pressure. BFR application with 80% pressure to one group of participants and 20% pressure to the other group will be applied simultaneously with the exercise. | Other | %20 BFR group, %80 BFR group |
Primary outcome
Visual analog scale
Time frame: 2 months
it will be used for assessment of pain intensity, It is scored between 0-10, and higher scores indicate that the situation is getting worse.
myoton
Time frame: 2 months
it will be used for assessment of muscle tonus and biomechanic properties, scores are changin according to different parameters.
dynamometer
Time frame: 2 months
it will be used for assessment of myscle strength, lower scores indicate that the situation is getting worse.
dolorimeter
Time frame: 2 months
it will be used for assessment of pain thresold pressure, lower scores indicate that the situation is getting worse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR technique in people with Pain Intensity, run by Istanbul University - Cerrahpasa at 2 sites 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamze Aydın, PhD (+905377600256, gmzetsn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.