Muscle TightnessNCT06371547
Efficiency of Different Gastrocnemius Stretching Exercises
A study testing Stretching Exercise in people with Muscle Tightness, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to investigate the effects of different types and durations of gastrocnemius stretching on the viscoelastic properties of the gastrocnemius muscle, Achilles tendon, and plantar fascia.In addition, pain threshold of the gastrocnemius muscle and plantar fascia, as well as on hamstring… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tightness
- What is being tested?
- Stretching Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 Dec 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18 to 25 years
- Having a gastrocnemius muscle tightness in the dominant side
Who cannot join
- History of lower extremity surgery or trauma
- Diagnosis of fibromyalgia, neurological disease, achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel pad syndrome
- Having received physiotherapy related to the lower extremities within the last six months
- A body mass index (BMI) above 30 kg/m2
- Having received a local steroid injection within the last six weeks
- The presence of a local infection
Show all 14Show fewer
- The presence of rheumatic or other systemic inflammatory diseases
- Diabetes or other metabolic diseases
- Nerve compression syndrome
- Currently using painkillers
- Diagnosis of neurological heel pain
- A positive navicular drop test result
- Having engaged in strenuous exercise within the last 24 hours
- Not being fully compliant with the exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Different Types of Stretching Exercises on Gastrocnemius Tightness
The primary aim of this study is to investigate the effects of different types and durations of gastrocnemius stretching on the viscoelastic properties of the gastrocnemius muscle, Achilles tendon, and plantar fascia.In addition, pain threshold of the gastrocnemius muscle and plantar fascia, as well as on hamstring tightness will be measured.
Read the detailed description
The study will include a total of at least 48 individuals who meet the inclusion and exclusion criteria. Subsequently, participants will be randomly assigned to one of four groups for gastrocnemius stretching exercises of different durations and types. Participants in Group I will perform sustained stretching with a towel, those in Group II will perform intermittent stretching with a towel, those in Group III will perform sustained stretching against the wall, and those in Group IV will perform intermittent stretching against the wall. The stretching exercises will be performed under the supervision of one of the researcher. Compliance with the stretching exercise will be evaluated by keeping a daily log.
- Conditions
- Muscle Tightness
- Being tested
- Stretching Exercise
- Keywords
- pain threshold, elasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching ExerciseOther
Participants will perform different types and durations of gastrocnemius muscle stretching exercises according to their assigned groups for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sustained stretching of the gastrocnemius muscle with a towel | Experimental | The participant will place a towel under the plantar surface of the foot and, using both hands, pull the towel towards themselves until they feel a stretch in the calf muscle. Subsequently, they will be asked to maintain this position for 3 minutes. The stretching exercise will be performed in 3 sets per day. Receives: Other: Stretching Exercise |
| Intermittent stretching of the gastrocnemius muscle with a towel | Experimental | In intermittent stretching with a towel, the individual will place a towel under the plantar surface of the foot and, using both hands, pull the towel towards themselves until they feel a stretch in the calf muscle. Subsequently, they will be instructed to maintain this position for 20 seconds. The stretching exercise will be performed in 2 sets per day, with 5 repetitions in each set. Receives: Other: Stretching Exercise |
| Sustained stretching against the wall | Experimental | In sustained stretching against the wall, individuals will be asked to place their hands on the wall at shoulder width apart. One leg will be positioned behind the other. Then, the front knee will be bent while keeping the back knee in extension and the heel in contact with the ground. Individuals will be instructed to bend their knees until they feel a stretch in the calf muscle. Subsequently, they will be asked to maintain this position for 3 minutes. The stretching exercise will be performed in 3 sets per day. Receives: Other: Stretching Exercise |
| Intermittent stretching against the wall | Experimental | During intermittent stretching against the wall, individuals will be instructed to place their hands on the wall at shoulder width apart. One leg will be positioned behind the other. Then, the knee of the front leg will be bent while the knee of the back leg continues to stay in extension, and the heel remains in contact with the ground. Individuals will be asked to bend their knee until they feel a stretch in the calf muscle. Subsequently, they will be instructed to maintain this position for 20 seconds. The stretching exercise will be performed in 2 sets per day, with 5 repetitions in each set. Receives: Other: Stretching Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the Viscoelastic Properties
The effect of stretches on the viscoelastic properties of the stretched muscle and its associated anatomical regions will be evaluated non-invasively using the myotonometer. Measurements will be taken on the medial and lateral gastrocnemius, Achilles tendon, and plantar fascia. The measurement areas will be marked prior to measurement. Measurements of the gastrocnemius and Achilles tendon will be taken with individuals lying prone, knees extended, and ankles in a neutral position. Measurement of plantar fascia tone will be taken with individuals lying prone, hips in neutral, knees extended, ankles in neutral position with goniometer assistance, and supported. All measurements will be taken three times, and the averages will be recorded.
Measured: Change from baseline viscoelastic properties at seventh and fourteen day
Ankle-foot Dorsiflexion Index
The ankle-foot dorsiflexion index will be used to assess both the tightness of the gastrocnemius muscle and the effectiveness of stretches. The individual's dorsiflexion range of motion will be measured using the lunge test, with measurements taken in both knee extension and flexion positions, and the difference between these measurements will be recorded as the ankle-foot dorsiflexion index.
Measured: Change from baseline ankle dorsiflexion range of motion at seventh and fourteen day
Secondary outcomes (2)
Measurement of the Mechanosensitivity
The effect of stretching on pain threshold will be assessed using an analog algometer. Pain threshold measurements will be taken on the gastrocnemius and plantar fascia. The measurement points for the gastrocnemius muscle will be the same as the viscoelastic measurement points. The measurement point for the plantar fascia will be the point where the plantar fascia attaches to the heel. Pain threshold measurements will be taken with the individual lying prone, with their feet hanging off the treatment bed. Measurements will be taken at each point with a 30-second interval, and three measurements will be taken for each point. The averages of these measurements will be calculated.
Measured: Change from baseline pain at seventh and fourteen day
Assessment of Hamstring Tightness
The hamstring muscle tightness in the individuals participating in the study will be assessed using the straight leg raise test. The straight leg raise test is particularly used to evaluate the tightness and elasticity of the hamstring muscles. For the test, the individual will be positioned in a supine lying position with the hip and knee joints in a neutral position. Subsequently, while the knee is in extension, the hip will gradually be brought into flexion. Hip flexion will be stopped when the individual feels discomfort from the tension behind the hip. Then, using a goniometer, the angle formed between the individual's lower extremity and the treatment bed will be measured. The center of the goniometer will be placed on the greater trochanter, with one arm along the lateral thigh and the other arm parallel to the treatment bed. An angle of 80 degrees is considered normal. The measurement will be repeated three times, and the average of the three measurements will be calculated.
Measured: Change from baseline hamstring tightness at seventh and fourteen day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Muscle TightnessStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Dursun, Bitlis Eren University
- Investigators
- Ömer Dursun, Asst. Prof., Principal investigator, Bitlis Eren UniversityErhan Dincer, M.Sc., Principal investigator, Bitlis Eren UniversityCihan Önen, Asst. Prof., Principal investigator, Bitlis Eren UniversityAbdurrahman Tanhan, Ph.D., Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371547
- Sponsor's protocol ID
- BEUFTR-3
- Status last verified
- Dec 2023
- First submitted
- 14 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cullen NP, Singh D. Plantar fasciitis: a review. Br J Hosp Med (Lond). 2006 Feb;67(2):72-6. doi: 10.12968/hmed.2006.67.2.20465. No abstract available.
PubMed 16498906Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.
PubMed 24626080Porter D, Barrill E, Oneacre K, May BD. The effects of duration and frequency of Achilles tendon stretching on dorsiflexion and outcome in painful heel syndrome: a randomized, blinded, control study. Foot Ankle Int. 2002 Jul;23(7):619-24. doi: 10.1177/107110070202300706.
PubMed 12146772Liu CL, Li YP, Wang XQ, Zhang ZJ. Quantifying the Stiffness of Achilles Tendon: Intra- and Inter-Operator Reliability and the Effect of Ankle Joint Motion. Med Sci Monit. 2018 Jul 14;24:4876-4881. doi: 10.12659/MSM.909531.
PubMed 30006997Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
PubMed 22506152Weerasinghe TW, Goonetilleke RS, Reischl U. Pressure thresholds and stiffness on the plantar surface of the human foot. Ergonomics. 2017 Jul;60(7):985-996. doi: 10.1080/00140139.2016.1229042. Epub 2016 Sep 26.
PubMed 27609429Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.
PubMed 24703512Bolivar YA, Munuera PV, Padillo JP. Relationship between tightness of the posterior muscles of the lower limb and plantar fasciitis. Foot Ankle Int. 2013 Jan;34(1):42-8. doi: 10.1177/1071100712459173.
PubMed 23386760McPoil TG, Cornwall MW. The relationship between static lower extremity measurements and rearfoot motion during walking. J Orthop Sports Phys Ther. 1996 Nov;24(5):309-14. doi: 10.2519/jospt.1996.24.5.309.
PubMed 8902683Naruseviciute D, Kubilius R. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: randomized participant blind controlled trial. Clin Rehabil. 2020 Aug;34(8):1072-1082. doi: 10.1177/0269215520929073. Epub 2020 Jun 8.
PubMed 32513018Monteagudo M, de Albornoz PM, Gutierrez B, Tabuenca J, Alvarez I. Plantar fasciopathy: A current concepts review. EFORT Open Rev. 2018 Aug 29;3(8):485-493. doi: 10.1302/2058-5241.3.170080. eCollection 2018 Aug.
PubMed 30237906Hirata K, Kanehisa H, Miyamoto N. Acute effect of static stretching on passive stiffness of the human gastrocnemius fascicle measured by ultrasound shear wave elastography. Eur J Appl Physiol. 2017 Mar;117(3):493-499. doi: 10.1007/s00421-017-3550-z. Epub 2017 Feb 4.
PubMed 28161870Kanehisa H, Ikegawa S, Tsunoda N, Fukunaga T. Cross-sectional areas of fat and muscle in limbs during growth and middle age. Int J Sports Med. 1994 Oct;15(7):420-5. doi: 10.1055/s-2007-1021081.
PubMed 8002122Masood T, Bojsen-Moller J, Kalliokoski KK, Kirjavainen A, Aarimaa V, Peter Magnusson S, Finni T. Differential contributions of ankle plantarflexors during submaximal isometric muscle action: a PET and EMG study. J Electromyogr Kinesiol. 2014 Jun;24(3):367-74. doi: 10.1016/j.jelekin.2014.03.002. Epub 2014 Mar 20.
PubMed 24717406Kamonseki DH, Goncalves GA, Yi LC, Junior IL. Effect of stretching with and without muscle strengthening exercises for the foot and hip in patients with plantar fasciitis: A randomized controlled single-blind clinical trial. Man Ther. 2016 Jun;23:76-82. doi: 10.1016/j.math.2015.10.006. Epub 2015 Oct 30.
PubMed 26654252
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Different Types of Stretching Exercises on Gastrocnemius Tightness
- ClinicalTrials.gov ID
- NCT06371547
- Acronym / sponsor ID
- BEUFTR-3
- Conditions
- Muscle Tightness
- Keywords
- pain threshold, elasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 17 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 primary aim of this study is to investigate the effects of different types and durations of gastrocnemius stretching on the viscoelastic properties of the gastrocnemius muscle, Achilles tendon, and plantar fascia.In addition, pain threshold of the gastrocnemius muscle and plantar fascia, as well as on hamstring tightness will be measured.
Detailed description
The study will include a total of at least 48 individuals who meet the inclusion and exclusion criteria. Subsequently, participants will be randomly assigned to one of four groups for gastrocnemius stretching exercises of different durations and types. Participants in Group I will perform sustained stretching with a towel, those in Group II will perform intermittent stretching with a towel, those in Group III will perform sustained stretching against the wall, and those in Group IV will perform intermittent stretching against the wall. The stretching exercises will be performed under the supervision of one of the researcher. Compliance with the stretching exercise will be evaluated by keeping a daily log.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sustained stretching of the gastrocnemius muscle with a towel | Experimental | Other: Stretching ExerciseThe participant will place a towel under the plantar surface of the foot and, using both hands, pull the towel towards themselves until they feel a stretch in the calf muscle. Subsequently, they will be asked to maintain this position for 3 minutes. The stretching exercise will be performed in 3 sets per day. |
| Intermittent stretching of the gastrocnemius muscle with a towel | Experimental | Other: Stretching ExerciseIn intermittent stretching with a towel, the individual will place a towel under the plantar surface of the foot and, using both hands, pull the towel towards themselves until they feel a stretch in the calf muscle. Subsequently, they will be instructed to maintain this position for 20 seconds. The stretching exercise will be performed in 2 sets per day, with 5 repetitions in each set. |
| Sustained stretching against the wall | Experimental | Other: Stretching ExerciseIn sustained stretching against the wall, individuals will be asked to place their hands on the wall at shoulder width apart. One leg will be positioned behind the other. Then, the front knee will be bent while keeping the back knee in extension and the heel in contact with the ground. Individuals will be instructed to bend their knees until they feel a stretch in the calf muscle. Subsequently, they will be asked to maintain this position for 3 minutes. The stretching exercise will be performed in 3 sets per day. |
| Intermittent stretching against the wall | Experimental | Other: Stretching ExerciseDuring intermittent stretching against the wall, individuals will be instructed to place their hands on the wall at shoulder width apart. One leg will be positioned behind the other. Then, the knee of the front leg will be bent while the knee of the back leg continues to stay in extension, and the heel remains in contact with the ground. Individuals will be asked to bend their knee until they feel a stretch in the calf muscle. Subsequently, they will be instructed to maintain this position for 20 seconds. The stretching exercise will be performed in 2 sets per day, with 5 repetitions in each set. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age of 18 to 25 years
- Having a gastrocnemius muscle tightness in the dominant side
Key exclusion criteria (14 listed)
- History of lower extremity surgery or trauma
- Diagnosis of fibromyalgia, neurological disease, achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel pad syndrome
- Having received physiotherapy related to the lower extremities within the last six months
- A body mass index (BMI) above 30 kg/m2
- Having received a local steroid injection within the last six weeks
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 |
|---|---|---|
| Stretching ExerciseParticipants will perform different types and durations of gastrocnemius muscle stretching exercises according to their assigned groups for two weeks. | Other | Intermittent stretching against the wall, Intermittent stretching of the gastrocnemius muscle with a towel, Sustained stretching against the wall, Sustained stretching of the gastrocnemius muscle with a towel |
Primary outcome
Measurement of the Viscoelastic Properties
Time frame: Change from baseline viscoelastic properties at seventh and fourteen day
The effect of stretches on the viscoelastic properties of the stretched muscle and its associated anatomical regions will be evaluated non-invasively using the myotonometer. Measurements will be taken on the medial and lateral gastrocnemius, Achilles tendon, and plantar fascia. The measurement areas will be marked prior to measurement. Measurements of the gastrocnemius and Achilles tendon will be taken with individuals lying prone, knees extended, and ankles in a neutral position. Measurement of plantar fascia tone will be taken with individuals lying prone, hips in neutral, knees extended, ankles in neutral position with goniometer assistance, and supported. All measurements will be taken three times, and the averages will be recorded.
Ankle-foot Dorsiflexion Index
Time frame: Change from baseline ankle dorsiflexion range of motion at seventh and fourteen day
The ankle-foot dorsiflexion index will be used to assess both the tightness of the gastrocnemius muscle and the effectiveness of stretches. The individual's dorsiflexion range of motion will be measured using the lunge test, with measurements taken in both knee extension and flexion positions, and the difference between these measurements will be recorded as the ankle-foot dorsiflexion index.
2 secondary outcomes
Measurement of the Mechanosensitivity
Time frame: Change from baseline pain at seventh and fourteen day
Assessment of Hamstring Tightness
Time frame: Change from baseline hamstring tightness at seventh and fourteen day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 16498906Cullen NP, Singh D. Plantar fasciitis: a review. Br J Hosp Med (Lond). 2006 Feb;67(2):72-6. doi: 10.12968/hmed.2006.67.2.20465. No abstract available.
- Background: PubMed 24626080Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.
- Background: PubMed 12146772Porter D, Barrill E, Oneacre K, May BD. The effects of duration and frequency of Achilles tendon stretching on dorsiflexion and outcome in painful heel syndrome: a randomized, blinded, control study. Foot Ankle Int. 2002 Jul;23(7):619-24. doi: 10.1177/107110070202300706.
- Background: PubMed 30006997Liu CL, Li YP, Wang XQ, Zhang ZJ. Quantifying the Stiffness of Achilles Tendon: Intra- and Inter-Operator Reliability and the Effect of Ankle Joint Motion. Med Sci Monit. 2018 Jul 14;24:4876-4881. doi: 10.12659/MSM.909531.
- Background: PubMed 22506152Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
- Background: PubMed 27609429Weerasinghe TW, Goonetilleke RS, Reischl U. Pressure thresholds and stiffness on the plantar surface of the human foot. Ergonomics. 2017 Jul;60(7):985-996. doi: 10.1080/00140139.2016.1229042. Epub 2016 Sep 26.
- Background: PubMed 24703512Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.
- Background: PubMed 23386760Bolivar YA, Munuera PV, Padillo JP. Relationship between tightness of the posterior muscles of the lower limb and plantar fasciitis. Foot Ankle Int. 2013 Jan;34(1):42-8. doi: 10.1177/1071100712459173.
- Background: PubMed 8902683McPoil TG, Cornwall MW. The relationship between static lower extremity measurements and rearfoot motion during walking. J Orthop Sports Phys Ther. 1996 Nov;24(5):309-14. doi: 10.2519/jospt.1996.24.5.309.
- Background: PubMed 32513018Naruseviciute D, Kubilius R. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: randomized participant blind controlled trial. Clin Rehabil. 2020 Aug;34(8):1072-1082. doi: 10.1177/0269215520929073. Epub 2020 Jun 8.
- Background: PubMed 30237906Monteagudo M, de Albornoz PM, Gutierrez B, Tabuenca J, Alvarez I. Plantar fasciopathy: A current concepts review. EFORT Open Rev. 2018 Aug 29;3(8):485-493. doi: 10.1302/2058-5241.3.170080. eCollection 2018 Aug.
- Background: PubMed 28161870Hirata K, Kanehisa H, Miyamoto N. Acute effect of static stretching on passive stiffness of the human gastrocnemius fascicle measured by ultrasound shear wave elastography. Eur J Appl Physiol. 2017 Mar;117(3):493-499. doi: 10.1007/s00421-017-3550-z. Epub 2017 Feb 4.
- 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.
Ömer Dursun, Asst. Prof. principal investigator
Bitlis Eren University
Erhan Dincer, M.Sc. principal investigator
Bitlis Eren University
Cihan Önen, Asst. Prof. principal investigator
Bitlis Eren 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 Stretching Exercise in people with Muscle Tightness, run by Bitlis Eren 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 2 inclusion and 14 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 17 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ömer Dursun, Asst. Prof. (5426088687 ext. +90, fztomrdrsn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the Viscoelastic Properties (time frame: Change from baseline viscoelastic properties at seventh and fourteen day). 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 NCT06371547, which also lists 15 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 17 Apr 2024.