Tennis Elbow SyndromeelbowNCT07710976
Blood Flow Restriction Training in Tennis Elbow
A study testing Blood Flow Restriction Training and Exercise without blood flow restriction in people with Tennis Elbow Syndrome, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis (LE) is a common musculoskeletal disorder caused by repetitive overuse of the forearm extensor muscles. It is characterized by pain over the lateral epicondyle of the humerus, which may radiate to the surrounding tissues at the origin of the wrist extensor tendons. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tennis Elbow Syndrome
- What is being tested?
- Blood Flow Restriction Training and Exercise without blood flow restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2025to 28 Feb 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 years;
- clinical diagnosis of lateral epicondylitis based on medical history and physical examination;
- pain intensity of ≥4 on a 10-cm Visual Analog Scale (VAS) during daily activities;
- provision of written informed consent.
Who cannot join
- hypertension, diabetes mellitus, cardiovascular disease, peripheral vascular disease, previous deep vein thrombosis, or lymphedema;
- orthopedic, rheumatologic, or neurological disorders affecting the upper extremity;
- fibromyalgia;
- congenital or acquired elbow deformity;
- previous trauma, fracture, or surgery involving the affected upper extremity;
- cervical radiculopathy or peripheral neuropathy affecting the involved limb;
Show all 12Show fewer
- receipt of any treatment for lateral epicondylitis within the preceding 3 months;
- skin lesions, infection, or open wounds at the cuff application site;
- bleeding disorders or current anticoagulant therapy;
- pregnancy;
- active malignancy or a history of malignancy;
- cognitive impairment or neurological or psychiatric disorders that could interfere with comprehension of study procedures or completion of outcome assessments.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Konya
About this study
Official title: Effects of Blood Flow Restriction Training on Pain, Function, Disability, Quality of Life, and Common Extensor Tendon Thickness and Echogenicity in Patients With Lateral Epicondylitis: A Prospective Randomized Controlled Trial
Lateral epicondylitis (LE) is a common musculoskeletal disorder caused by repetitive overuse of the forearm extensor muscles. It is characterized by pain over the lateral epicondyle of the humerus, which may radiate to the surrounding tissues at the origin of the wrist extensor tendons. LE is one of the most frequent causes of lateral elbow pain, with a reported prevalence of approximately 1-3% in the general population.
Among conservative interventions, exercise-based rehabilitation is considered a cornerstone of management. In particular, exercise programs incorporating eccentric contractions have demonstrated superior clinical outcomes compared with several other exercise approaches and are therefore widely recommended.
Read more
Blood flow restriction training (BFRT) has recently emerged as an alternative rehabilitation strategy that promotes neuromuscular adaptations while using low mechanical loads. BFRT involves the application of a pneumatic cuff, tourniquet, or elastic band around the proximal portion of an extremity to partially restrict arterial inflow while substantially reducing venous return, thereby creating localized metabolic and hemodynamic stress during exercise.
The primary aim of this randomized controlled trial was to investigate the effects of BFRT on pain, functional status, pain-free grip strength, health-related quality of life, and ultrasonographic characteristics of the common extensor tendon in patients with lateral epicondylitis.
Read the detailed description
Lateral epicondylitis (LE) is a common musculoskeletal disorder caused by repetitive overuse of the forearm extensor muscles. It is characterized by pain over the lateral epicondyle of the humerus, which may radiate to the surrounding tissues at the origin of the wrist extensor tendons. LE is one of the most frequent causes of lateral elbow pain, with a reported prevalence of approximately 1-3% in the general population. Although numerous conservative and invasive treatment modalities have been described, no universally accepted treatment algorithm currently exists. Among conservative interventions, exercise-based rehabilitation is considered a cornerstone of management because it improves tendon load tolerance, increases muscle strength, and facilitates functional recovery.
Although no consensus has been reached regarding the optimal exercise protocol, recent research has focused on interventions that enhance the adaptation of the common extensor tendon to mechanical loading. In particular, exercise programs incorporating eccentric contractions have demonstrated superior clinical outcomes compared with several other exercise approaches and are therefore widely recommended. Furthermore, regular exercise has been shown to improve tendon mechanical properties by increasing collagen synthesis as well as collagen fiber number and diameter.
To achieve meaningful improvements in muscle strength and hypertrophy, resistance exercise is generally recommended at loads of at least 70% of the one-repetition maximum (1RM). However, such loading is often poorly tolerated by individuals experiencing pain, muscle weakness, or muscle atrophy during the early stages of musculoskeletal rehabilitation. Consequently, high-intensity resistance exercise may exacerbate symptoms and reduce treatment adherence.
Blood flow restriction training (BFRT) has recently emerged as an alternative rehabilitation strategy that promotes neuromuscular adaptations while using low mechanical loads. BFRT involves the application of a pneumatic cuff, tourniquet, or elastic band around the proximal portion of an extremity to partially restrict arterial inflow while substantially reducing venous return, thereby creating localized metabolic and hemodynamic stress during exercise.
In BFRT, resistance exercises are typically performed at 20-30% of the one-repetition maximum (1RM). Despite the low training intensity, accumulating evidence indicates that BFRT can produce gains in muscle strength and hypertrophy comparable to those achieved with conventional high-intensity resistance training.
These characteristics make BFRT an attractive adjunct or alternative to traditional resistance exercise in musculoskeletal rehabilitation, particularly for minimizing excessive tissue loading during tendon healing, preventing muscle atrophy, and preserving functional capacity. Nevertheless, evidence regarding the effects of BFRT on clinical outcomes and tendon morphology in patients with lateral epicondylitis remains limited.
The primary aim of this randomized controlled trial was to investigate the effects of BFRT on pain, functional status, pain-free grip strength, health-related quality of life, and ultrasonographic characteristics of the common extensor tendon in patients with lateral epicondylitis. A secondary aim was to compare these outcomes with those achieved using a conventional exercise program and to determine whether BFRT induces measurable structural changes in tendon morphology as assessed by ultrasonography.
- Conditions
- Tennis Elbow Syndrome
- Being tested
- Blood Flow Restriction Training, Exercise without blood flow restriction
- Keywords
- Tennis elbow, grip strength, blood flow restriction training, rehabilitation, ultrasonography, quality of life
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TrainingProcedure or surgery
Both groups participated in a supervised exercise program consisting of 12 sessions over four weeks (three sessions per week), with each session lasting approximately 45 minutes. Each treatment session began with 3-5 minutes of transverse friction massage applied to the painful region, followed by gentle circular soft-tissue mobilization in a proximal-to-distal direction. Resistance exercises were then performed using dumbbells and consisted of concentric and eccentric wrist extension and forearm supination exercises. The order of exercises was standardized for all participants throughout the intervention period.
Participants allocated to the BFRT group performed the exercise program under blood flow restriction using a pneumatic cuff positioned around the proximal portion of the affected upper arm. Before the intervention, arterial occlusion pressure (AOP) was individually determined for each participant. The cuff pressure used during training was set at 50% of the individual AOP. Tot
Exercise without blood flow restrictionProcedure or surgery
Participants in the control group performed the identical exercise protocol without blood flow restriction.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction training (BFRT) group | Experimental | The exercise program in this group was performed under blood flow restriction using a pneumatic cuff positioned around the proximal portion of the affected upper arm. Receives: Procedure: Blood Flow Restriction Training |
| Control group | Active comparator | Participants in the control group performed the same exercise protocol without blood flow restriction. Receives: Procedure: Exercise without blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Tennis Elbow Evaluation (PRTEE)
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a disease-specific, patient-reported outcome measure designed to assess pain and functional disability associated with lateral epicondylitis (14,15). The questionnaire consists of two domains evaluating pain and functional limitations, with a total score ranging from 0 to 100, where higher scores indicate greater pain and disability. The Turkish version of the PRTEE has demonstrated satisfactory validity and reliability
Measured: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
Secondary outcomes (4)
Visual Analog Scale (VAS)
Pain intensity at rest and during activity was assessed using a 10-cm Visual Analog Scale (VAS). The scale ranges from 0 ("no pain") to 10 ("worst imaginable pain"). Participants were instructed to indicate the intensity of their pain by marking a point on the scale corresponding to their perceived pain level. The score was determined by measuring the distance (cm) from the left endpoint to the participant's mark. The VAS is a valid and reliable instrument for assessing pain intensity in patients with musculoskeletal disorders.
Measured: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
Pain-free grip strength (PFGS) Assessment
PFGS is considered a sensitive indicator of functional impairment in patients with lateral epicondylitis. Participants were seated with the shoulder in a neutral position, the elbow comfortably extended, and the forearm pronated. Firstly, maximal grip strength was measured using a Jamar hydraulic hand dynamometer in kilograms on the unaffected side. Participants were then instructed to gradually squeeze the dynamometer with the affected hand and stop immediately when pain was first perceived. Three measurements were obtained for each assessment with a 20-second rest interval between trials, and the mean value was used for analysis. PFGS was calculated as the ratio of pain-free grip strength of the affected side to maximal grip strength of the unaffected side. This method has been shown to provide excellent reliability in individuals with lateral epicondylitis.
Measured: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
Health-Related Quality of Life
Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36). The SF-36 comprises eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life. The Turkish version of the SF-36 has been validated and shown to be reliable
Measured: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
Ultrasonographic Evaluation of the Common Extensor Tendon
Ultrasonographic examinations were performed using a 7-12 MHz linear-array transducer (Logiq P8; GE Healthcare, Wisconsin, USA). The measurements were taken by a researcher with four years of experience in musculoskeletal ultrasound who did not know which group the patients belonged to.
Participants were examined in a seated position with the elbow flexed to 90° and the forearm pronated. Longitudinal images of the common extensor tendon were obtained, and tendon thickness perpendicular to the tendon fibers, was measured at two standardized anatomical landmarks: (1) the deepest point over the capitellum and (2) the midpoint of the radiocapitellar joint. To improve measurement reliability, each measurement was repeated three times, and the mean value was used for statistical analyses.
Measured: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start28 Feb 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis Elbow SyndromeStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAMİ KÜÇÜKŞEN, Necmettin Erbakan University
- Investigators
- SAMİ KÜÇÜKŞEN, Professor, Study director, Necmettin Erbakan University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710976
- Sponsor's protocol ID
- 2025/5793
- Acronym
- elbow
- Status last verified
- May 2025
- First submitted
- 14 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Training on Pain, Function, Disability, Quality of Life, and Common Extensor Tendon Thickness and Echogenicity in Patients With Lateral Epicondylitis: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07710976
- Acronym / sponsor ID
- elbow / 2025/5793
- Conditions
- Tennis Elbow Syndrome
- Keywords
- Tennis elbow, grip strength, blood flow restriction training, rehabilitation, ultrasonography, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 17 Jul 2026 (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.
Lateral epicondylitis (LE) is a common musculoskeletal disorder caused by repetitive overuse of the forearm extensor muscles. It is characterized by pain over the lateral epicondyle of the humerus, which may radiate to the surrounding tissues at the origin of the wrist extensor tendons. LE is one of the most frequent causes of lateral elbow pain, with a reported prevalence of approximately 1-3% in the general population.
Among conservative interventions, exercise-based rehabilitation is considered a cornerstone of management. In particular, exercise programs incorporating eccentric contractions have demonstrated superior clinical outcomes compared with several other exercise approaches and are therefore widely recommended.
Blood flow restriction training (BFRT) has recently emerged as an alternative rehabilitation strategy that promotes neuromuscular adaptations while using low mechanical loads. BFRT involves the application of a pneumatic cuff, tourniquet, or elastic band around the proximal portion of an extremity to partially restrict arterial inflow while substantially reducing venous return, thereby creating localized metabolic and hemodynamic stress during exercise.
The primary aim of this randomized controlled trial was to investigate the effects of BFRT on pain, functional status, pain-free grip strength, health-related quality of life, and ultrasonographic characteristics of the common extensor tendon in patients with lateral epicondylitis.
Detailed description
Lateral epicondylitis (LE) is a common musculoskeletal disorder caused by repetitive overuse of the forearm extensor muscles. It is characterized by pain over the lateral epicondyle of the humerus, which may radiate to the surrounding tissues at the origin of the wrist extensor tendons. LE is one of the most frequent causes of lateral elbow pain, with a reported prevalence of approximately 1-3% in the general population. Although numerous conservative and invasive treatment modalities have been described, no universally accepted treatment algorithm currently exists. Among conservative interventions, exercise-based rehabilitation is considered a cornerstone of management because it improves tendon load tolerance, increases muscle strength, and facilitates functional recovery.
Although no consensus has been reached regarding the optimal exercise protocol, recent research has focused on interventions that enhance the adaptation of the common extensor tendon to mechanical loading. In particular, exercise programs incorporating eccentric contractions have demonstrated superior clinical outcomes compared with several other exercise approaches and are therefore widely recommended. Furthermore, regular exercise has been shown to improve tendon mechanical properties by increasing collagen synthesis as well as collagen fiber number and diameter.
To achieve meaningful improvements in muscle strength and hypertrophy, resistance exercise is generally recommended at loads of at least 70% of the one-repetition maximum (1RM). However, such loading is often poorly tolerated by individuals experiencing pain, muscle weakness, or muscle atrophy during the early stages of musculoskeletal rehabilitation. Consequently, high-intensity resistance exercise may exacerbate symptoms and reduce treatment adherence.
Blood flow restriction training (BFRT) has recently emerged as an alternative rehabilitation strategy that promotes neuromuscular adaptations while using low mechanical loads. BFRT involves the application of a pneumatic cuff, tourniquet, or elastic band around the proximal portion of an extremity to partially restrict arterial inflow while substantially reducing venous return, thereby creating localized metabolic and hemodynamic stress during exercise.
In BFRT, resistance exercises are typically performed at 20-30% of the one-repetition maximum (1RM). Despite the low training intensity, accumulating evidence indicates that BFRT can produce gains in muscle strength and hypertrophy comparable to those achieved with conventional high-intensity resistance training.
These characteristics make BFRT an attractive adjunct or alternative to traditional resistance exercise in musculoskeletal rehabilitation, particularly for minimizing excessive tissue loading during tendon healing, preventing muscle atrophy, and preserving functional capacity. Nevertheless, evidence regarding the effects of BFRT on clinical outcomes and tendon morphology in patients with lateral epicondylitis remains limited.
The primary aim of this randomized controlled trial was to investigate the effects of BFRT on pain, functional status, pain-free grip strength, health-related quality of life, and ultrasonographic characteristics of the common extensor tendon in patients with lateral epicondylitis. A secondary aim was to compare these outcomes with those achieved using a conventional exercise program and to determine whether BFRT induces measurable structural changes in tendon morphology as assessed by ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction training (BFRT) group | Experimental | Procedure: Blood Flow Restriction TrainingThe exercise program in this group was performed under blood flow restriction using a pneumatic cuff positioned around the proximal portion of the affected upper arm. |
| Control group | Active comparator | Procedure: Exercise without blood flow restrictionParticipants in the control group performed the same exercise protocol without blood flow restriction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 75 years;
- clinical diagnosis of lateral epicondylitis based on medical history and physical examination;
- pain intensity of ≥4 on a 10-cm Visual Analog Scale (VAS) during daily activities;
- provision of written informed consent.
Key exclusion criteria (12 listed)
- hypertension, diabetes mellitus, cardiovascular disease, peripheral vascular disease, previous deep vein thrombosis, or lymphedema;
- orthopedic, rheumatologic, or neurological disorders affecting the upper extremity;
- fibromyalgia;
- congenital or acquired elbow deformity;
- previous trauma, fracture, or surgery involving the affected upper extremity;
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 Restriction TrainingBoth groups participated in a supervised exercise program consisting of 12 sessions over four weeks (three sessions per week), with each session lasting approximately 45 minutes. Each treatment session began with 3-5 minutes of transverse friction massage applied to the painful region, followed by gentle circular soft-tissue mobilization in a proximal-to-distal direction. Resistance exercises were then performed using dumbbells and consisted of concentric and eccentric wrist extension and forearm supination exercises. The order of exercises was standardized for all participants throughout the intervention period. Participants allocated to the BFRT group performed the exercise program under blood flow restriction using a pneumatic cuff positioned around the proximal portion of the affected upper arm. Before the intervention, arterial occlusion pressure (AOP) was individually determined for each participant. The cuff pressure used during training was set at 50% of the individual AOP. Tot | Procedure or surgery | Blood flow restriction training (BFRT) group |
| Exercise without blood flow restrictionParticipants in the control group performed the identical exercise protocol without blood flow restriction. | Procedure or surgery | Control group |
Primary outcome
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a disease-specific, patient-reported outcome measure designed to assess pain and functional disability associated with lateral epicondylitis (14,15). The questionnaire consists of two domains evaluating pain and functional limitations, with a total score ranging from 0 to 100, where higher scores indicate greater pain and disability. The Turkish version of the PRTEE has demonstrated satisfactory validity and reliability
4 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
Pain-free grip strength (PFGS) Assessment
Time frame: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
Health-Related Quality of Life
Time frame: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
Ultrasonographic Evaluation of the Common Extensor Tendon
Time frame: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).
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 21 Jul 2026.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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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.
SAMİ KÜÇÜKŞEN, Professor study director
Necmettin Erbakan University, Faculty of Medicine
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 Training and Exercise without blood flow restriction in people with Tennis Elbow Syndrome, run by Necmettin Erbakan 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 4 inclusion and 12 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 21 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?
Patient-Rated Tennis Elbow Evaluation (PRTEE) (time frame: Baseline, at 4 weeks (end of intervention), and at 12 weeks (follow-up).). 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 21 Jul 2026.