Lateral EpicondylitisNCT06001944
Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy
A study testing Blood flow restriction and Multimodal rehabilitation in people with Lateral Epicondylitis and Tennis Elbow, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The investigators believe that blood flow-restricted training can result in increased caste hypertrophy and strength without stressing the tendon in lateral elbow tendinopathy, and that changes in local metabolic activities can be effective in the process of tendon healing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow, Tendonitis Elbow
- What is being tested?
- Blood flow restriction and Multimodal rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2023to 11 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years of age,
- Lateral tendinopathy diagnosis,
- Have scored 33 or more out of 100 on the Patient Based Tennis elbow Assessment Test (PRTEE).
Who cannot join
- Dysfunction in the shoulder, neck and/or chest area,
- Local or generalized arthritis.
- The neurological deficit.
- Radial dysfunction,
- Limitation of arm functions,
- A history of shoulder or upper extremity pathology requiring surgery or treatment;
Show all 15Show fewer
- Venous thromboembolism
- Inflammation or other hematological disorders.
- Coronary artery disease,
- Peripheral arterial disease or hypertension (systolic/diastolic blood pressure >140 mm Hg/90 mmHg),
- To be pregnant,
- Irritation of median nerves.
- Irritation of radial nerves.
- Irritation of the ulnar nerves,
- The pain score is less than 30 mm.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University - Cerrahpasa
Istanbul, Büyükçekmece, No:5/9/1
Fulya DEMIRHAN, PHd Student, +90-532-353-2208, f.gurcenan@hotmail.com
About this study
The investigators believe that blood flow-restricted training can result in increased caste hypertrophy and strength without stressing the tendon in lateral elbow tendinopathy, and that changes in local metabolic activities can be effective in the process of tendon healing. The researchers' aim in the study is to investigate the effectiveness of blood flow restriction training in lateral elbow tendinopathy for 8 weeks, in addition to the 2 days a week multi-modal physiotherapy program, which will be applied by limiting blood flow by 40-50% occlusion recommended for the upper extremity using the patient's systolic pressure to the severity of 20-30% of 1 maximum repetition, 75 repetitions including 30-15-15-15 repetitions and 30 seconds rest period between sets, remaining attached to the recommended 10-15 minutes period for the top extremity.
Read the detailed description
Physiotherapy is the first step in the treatment algorithm for lateral elbow tendinopathy (LET), which is characterized by pain in the lateral epicondyl of the humerus during wrist extension and which limits hand-to-hand movements such as grabbing and thinning and consequently negatively affects hand functions. Extender carpi radialis brevis (ECRB) and extender digitorum, communis (EDC) are the muscles that contribute most to the onset of symptoms. Exercise, either alone or as part of a multimodal physiotherapy program, is central to the management of many patients with LDT. Exercise in patients with chronic LDT has been shown to result in more and faster relief of pain, less use of illness, less medical consultation, and increased working capacity. In literature, loading with recommended exercises is considered necessary to re-form the tendon, while on the other hand some patients may not tolerate this loading. For rehabilitation practitioners, it is quite difficult to design optimal exercise programs that facilitate musculo-skeletal system (MSK) adaptations while also enabling biological healing and safe loading of the injured body. In these cases, there has been a search for a new method that can generate physiological benefits associated with higher intensity training with exercise at lower loads. Increasing evidence supports the use of resistance training at a reduced load along with blood flow restriction (BFR) therapy to increase hypertrophic and force responses in skeletal muscle. The American Association of Sports Physicians (ACSM) recommends that at least 65% of the 1 maximum repetition, similar to exercising at high intensity with 8-12 repetition resistant weight lifting strength training, can be used in low loads such as 20% to 30% of 1 maximum repeat in the treatment to caste hypertrophy and strength. Effects of blood flow-restricted training on muscle lithium excitement, mechanical tension, metabolic stress, systemic and local hormones, vascular endothelial growth factor (VEGF) and oxidative stress mechanisms have been. There have been no randomized controlled studies in the literature on the effectiveness of BFR training in tendinopathies. However, case studies and series of cases have been included and no contraindications of BFR have been for patients with tendinopathy. The increasing number of studies on various diseases in the literature is a proof of this.
- Conditions
- Lateral Epicondylitis, Tennis Elbow, Tendonitis Elbow
- Being tested
- Blood flow restriction, Multimodal rehabilitation
- Keywords
- lateral elbow tendinopathy, blood flow restriction, exercise
- Medical subject headings
- Tennis Elbow, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restrictionOther
The BFR training group will be given detailed information about the technique and discussed possible side effects.The American Association of Sports Physicians (ACSM) recommends that at least 65% of 1 maximum repetition, similar to high-intensity exercise, 8-12 repetitions of resistant weight lifting strength training, can be used with low loads such as 20% to 30% of the maximum 1 repetition in therapy to caste hypertrophy and strength.
Multimodal rehabilitationOther
Patients with LDT will be informed that the condition will be gradually resolved with adequate rest and time.
Exercise Training will consist of 3 phases.The goal is to protect the injured tissue from stress during the first phase of rehabilitation during the protective phase but not to restrict its function. In this phase, the use of counterforce breys, cold application, cyriax physiotherapy, Mill's manipulation, elbow mobilization and stretching to the wrist extensors will be applied. The program will be created taking into account the principle of proximal stability for distal mobility during the reinforcement phase. The rotator manchet will be added to the program. It will be active first in the exercise and then progresses resistantly according to the condition of the patient. After distal strengthening, the dress will be transferred to stabilization exercises where flexion and extension reveal simultaneous contraction.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 8 weeks, 2 days a week, a multi-model rehabilitation program is implemented. Receives: Other: Multimodal rehabilitation |
| Experimental group | Experimental | 8 weeks, 2 days a week, blood flow restriction during exercise will be applied in addition to the multi-model rehabilitation program. The elbow will be placed near the elbow and the patient's systolic pressure will be used to restrict the blood flow with the recommended 40%-50% occlusion for the upper extremity, and the exercise intensity will be performed 75 times at 20-30% of 1 maximum repetition, 30-15-15-15 repetition and 30 seconds rest between sets. Receives: Other: Blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
In the resting position, a 100 mm long line will be drawn and patients will be asked to mark the area where they express the severity of the pain on that line.
Measured: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Painless Grip Strength
Average values of 3 repeated measurements with the Baseline dynamometer will be recorded while the patient is sitting upright, at shoulder adduction, at 90 degree flexion of the elbow, supported at the middle rotation of the front arm and while the wrist is in a neutral position.
Measured: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Patient-rated tennis elbow evaluation (PRTEE)
It consists of two subheadings, pain and function. Function subheadings include specific activities and general activities, and each subgroup takes a value from 0 to 10. For the total score, the average of individual and general activity scores is collected with the total pain score. The result is a value between 0 and 100.
Measured: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Secondary outcomes (5)
SF-12 Quality of Life Questionnaire
The SF-12 consist of 12 items assesing physical and mental health and yields 2 summary scores; the mental component summary and physical component summary. Scoring is norm based with a mean of 50; higher scores indicate better health.
Measured: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Global Rating of Change
Global rating of change scale quantifies a patient's improvement or deterioration over time, and identifies the effect of an intervention or charts the clinical course of a condition. The patient selects between "much worse", "slightly worse", "stayed at same", "slightly better" and, "much better".
Measured: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Range of Motion
The range of motion clarity of the shoulder, elbow, front arm and wrist joints in resting position using the gonyometer will be tested.
Measured: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Manual Muscle Testing
The upper, middle and lower trapezoidal muscles, serratus anterior, biceps brachii and triceps brachii will be evaluated.
Measured: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Pressure-Pain Threshold Measurement
An algometer is a device consisting of a frame displaying the pressure to be applied to this piston with a metal piston containing a round disk of about 1 cm in diameter at the end. The algometer will be asked to tell the patient the level of discomfort by pressing it at a straight angle to the most sensitive area in the lateral epicondyl area. The pressure value for the pain sensation will be determined as the pain threshold and the values obtained in kilograms (kg) will be recorded.
Measured: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start11 Apr 2023
- Primary completion11 Apr 2024 (estimated)
- Study completion11 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Demirhan, Istanbul University - Cerrahpasa
- Investigators
- Yıldız ANALAY AKBABA, Assoc. prof., Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001944
- Sponsor's protocol ID
- 665912
- Status last verified
- Aug 2023
- First submitted
- 1 Jun 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim YJ, Wood SM, Yoon AP, Howard JC, Yang LY, Chung KC. Efficacy of Nonoperative Treatments for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2021 Jan 1;147(1):112-125. doi: 10.1097/PRS.0000000000007440.
PubMed 33002980Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.
PubMed 31543413Karanasios S, Korakakis V, Moutzouri M, Xergia SA, Tsepis E, Gioftsos G. Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. J Orthop Sports Phys Ther. 2022 Dec;52(12):803-825. doi: 10.2519/jospt.2022.11211. Epub 2022 Sep 13.
PubMed 36099170Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.
PubMed 26381484Ozdincler AR, Baktir ZS, Mutlu EK, Kocyigit A. Chronic lateral elbow tendinopathy with a supervised graded exercise protocol. J Hand Ther. 2023 Oct-Dec;36(4):913-922. doi: 10.1016/j.jht.2022.11.005. Epub 2023 Mar 11.
PubMed 36914496
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy
- ClinicalTrials.gov ID
- NCT06001944
- Acronym / sponsor ID
- 665912
- Conditions
- Lateral Epicondylitis, Tennis Elbow, Tendonitis Elbow
- Keywords
- lateral elbow tendinopathy, blood flow restriction, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 11 Apr 2024 (estimated)
- Study completion
- 11 Apr 2024 (estimated)
- First posted
- 21 Aug 2023 (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 investigators believe that blood flow-restricted training can result in increased caste hypertrophy and strength without stressing the tendon in lateral elbow tendinopathy, and that changes in local metabolic activities can be effective in the process of tendon healing. The researchers' aim in the study is to investigate the effectiveness of blood flow restriction training in lateral elbow tendinopathy for 8 weeks, in addition to the 2 days a week multi-modal physiotherapy program, which will be applied by limiting blood flow by 40-50% occlusion recommended for the upper extremity using the patient's systolic pressure to the severity of 20-30% of 1 maximum repetition, 75 repetitions including 30-15-15-15 repetitions and 30 seconds rest period between sets, remaining attached to the recommended 10-15 minutes period for the top extremity.
Detailed description
Physiotherapy is the first step in the treatment algorithm for lateral elbow tendinopathy (LET), which is characterized by pain in the lateral epicondyl of the humerus during wrist extension and which limits hand-to-hand movements such as grabbing and thinning and consequently negatively affects hand functions. Extender carpi radialis brevis (ECRB) and extender digitorum, communis (EDC) are the muscles that contribute most to the onset of symptoms. Exercise, either alone or as part of a multimodal physiotherapy program, is central to the management of many patients with LDT. Exercise in patients with chronic LDT has been shown to result in more and faster relief of pain, less use of illness, less medical consultation, and increased working capacity. In literature, loading with recommended exercises is considered necessary to re-form the tendon, while on the other hand some patients may not tolerate this loading. For rehabilitation practitioners, it is quite difficult to design optimal exercise programs that facilitate musculo-skeletal system (MSK) adaptations while also enabling biological healing and safe loading of the injured body. In these cases, there has been a search for a new method that can generate physiological benefits associated with higher intensity training with exercise at lower loads. Increasing evidence supports the use of resistance training at a reduced load along with blood flow restriction (BFR) therapy to increase hypertrophic and force responses in skeletal muscle. The American Association of Sports Physicians (ACSM) recommends that at least 65% of the 1 maximum repetition, similar to exercising at high intensity with 8-12 repetition resistant weight lifting strength training, can be used in low loads such as 20% to 30% of 1 maximum repeat in the treatment to caste hypertrophy and strength. Effects of blood flow-restricted training on muscle lithium excitement, mechanical tension, metabolic stress, systemic and local hormones, vascular endothelial growth factor (VEGF) and oxidative stress mechanisms have been. There have been no randomized controlled studies in the literature on the effectiveness of BFR training in tendinopathies. However, case studies and series of cases have been included and no contraindications of BFR have been for patients with tendinopathy. The increasing number of studies on various diseases in the literature is a proof of this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Multimodal rehabilitation8 weeks, 2 days a week, a multi-model rehabilitation program is implemented. |
| Experimental group | Experimental | Other: Blood flow restriction8 weeks, 2 days a week, blood flow restriction during exercise will be applied in addition to the multi-model rehabilitation program. The elbow will be placed near the elbow and the patient's systolic pressure will be used to restrict the blood flow with the recommended 40%-50% occlusion for the upper extremity, and the exercise intensity will be performed 75 times at 20-30% of 1 maximum repetition, 30-15-15-15 repetition and 30 seconds rest between sets. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18 and 65 years of age,
- Lateral tendinopathy diagnosis,
- Have scored 33 or more out of 100 on the Patient Based Tennis elbow Assessment Test (PRTEE).
Key exclusion criteria (15 listed)
- Dysfunction in the shoulder, neck and/or chest area,
- Local or generalized arthritis.
- The neurological deficit.
- Radial dysfunction,
- Limitation of arm functions,
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 |
|---|---|---|
| Blood flow restrictionThe BFR training group will be given detailed information about the technique and discussed possible side effects.The American Association of Sports Physicians (ACSM) recommends that at least 65% of 1 maximum repetition, similar to high-intensity exercise, 8-12 repetitions of resistant weight lifting strength training, can be used with low loads such as 20% to 30% of the maximum 1 repetition in therapy to caste hypertrophy and strength. | Other | Experimental group |
| Multimodal rehabilitationPatients with LDT will be informed that the condition will be gradually resolved with adequate rest and time. Exercise Training will consist of 3 phases.The goal is to protect the injured tissue from stress during the first phase of rehabilitation during the protective phase but not to restrict its function. In this phase, the use of counterforce breys, cold application, cyriax physiotherapy, Mill's manipulation, elbow mobilization and stretching to the wrist extensors will be applied. The program will be created taking into account the principle of proximal stability for distal mobility during the reinforcement phase. The rotator manchet will be added to the program. It will be active first in the exercise and then progresses resistantly according to the condition of the patient. After distal strengthening, the dress will be transferred to stabilization exercises where flexion and extension reveal simultaneous contraction. | Other | Control group |
Primary outcome
Visual Analog Scale
Time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
In the resting position, a 100 mm long line will be drawn and patients will be asked to mark the area where they express the severity of the pain on that line.
Painless Grip Strength
Time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Average values of 3 repeated measurements with the Baseline dynamometer will be recorded while the patient is sitting upright, at shoulder adduction, at 90 degree flexion of the elbow, supported at the middle rotation of the front arm and while the wrist is in a neutral position.
Patient-rated tennis elbow evaluation (PRTEE)
Time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
It consists of two subheadings, pain and function. Function subheadings include specific activities and general activities, and each subgroup takes a value from 0 to 10. For the total score, the average of individual and general activity scores is collected with the total pain score. The result is a value between 0 and 100.
5 secondary outcomes
SF-12 Quality of Life Questionnaire
Time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Global Rating of Change
Time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Range of Motion
Time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Manual Muscle Testing
Time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Pressure-Pain Threshold Measurement
Time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 33002980Kim YJ, Wood SM, Yoon AP, Howard JC, Yang LY, Chung KC. Efficacy of Nonoperative Treatments for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2021 Jan 1;147(1):112-125. doi: 10.1097/PRS.0000000000007440.
- Background: PubMed 31543413Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.
- Background: PubMed 36099170Karanasios S, Korakakis V, Moutzouri M, Xergia SA, Tsepis E, Gioftsos G. Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. J Orthop Sports Phys Ther. 2022 Dec;52(12):803-825. doi: 10.2519/jospt.2022.11211. Epub 2022 Sep 13.
- Background: PubMed 26381484Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.
- Background: PubMed 36914496Ozdincler AR, Baktir ZS, Mutlu EK, Kocyigit A. Chronic lateral elbow tendinopathy with a supervised graded exercise protocol. J Hand Ther. 2023 Oct-Dec;36(4):913-922. doi: 10.1016/j.jht.2022.11.005. Epub 2023 Mar 11.
- 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.
Yıldız ANALAY AKBABA, Assoc. prof. study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction and Multimodal rehabilitation in people with Lateral Epicondylitis and Tennis Elbow, run by Istanbul University - Cerrahpasa 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 3 inclusion and 15 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 21 Aug 2023. 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 Fulya DEMIRHAN, PHd Student (+90-532-353-2208, f.gurcenan@hotmail.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: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up). The study lists 3 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 NCT06001944, which also lists 5 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 21 Aug 2023.