Tennis ElbowNCT06490692
The Effect of Blood Flow Restriction Training on Tennis Elbow
A study testing Blood Flow Restriction Training and Conventional Strength Training in people with Tennis Elbow and Lateral Epicondylitis, run by Cairo University at 1 site in Lebanon.
Trial summary
The goal of this randomized controlled clinical trial is to investigate the effects of blood flow restriction training on the parameters surrounding tennis elbow afflicted patients including pain, disability, and grip strength. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Tennis Elbow, Lateral Epicondylitis, Lateral Epicondylitis, Unspecified Elbow
- What is being tested?
- Blood Flow Restriction Training and Conventional Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteLebanon
- Study dates
- 29 Jun 2024to 1 Nov 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 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients that were included in this study were diagnosed with lateral epicondylitis by a medical doctor for less than 3 months.
- Dominant hand was diagnosed with lateral epicondylitis.
- They were aged between 20 and 40 years old.
- With decreased grip strength and wrist range of motion.
- No history of physical therapy treatment for lateral epicondylitis for at least 6 months.
Who cannot join
- Patients with chronic diabetes.
- Any type of trauma or fracture in the upper extremities in the last 3 months.
- Patients with any vestibular problems.
- Patients with deep vein thrombosis (DVT).
- Patients with hypertension.
- Patients with cancer.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Beirut Arab University
Beirut, 0000
Ahmed Mohammed El Melhat, PhD, 20 1112595022, a.melhat@bau.edu.lb
About this study
Official title: Ffect of Blood Flow Restriction Training on Lateral Epicondylitis Parameters in Patients With Tennis Elbow
The goal of this randomized controlled clinical trial is to investigate the effects of blood flow restriction training on the parameters surrounding tennis elbow afflicted patients including pain, disability, and grip strength.
The main question this study aims to answer is:
1- Does blood flow restriction training offer significantly better effects on pain, disability, and grip strength when compared to conventional strength training without blood flow restriction in patients afflicted with tennis elbow? Research will compare two groups with tennis elbow where both will perform the same rehabilitation program consisting of conventional physical therapy for tennis elbow as well as a strength training program with the only difference being that one group will undergo blood flow restriction training while the other will not.
Read the detailed description
Lateral epicondylitis, commonly known as Tennis elbow, is a musculoskeletal condition characterized by pain at the lateral epicondyle due to repetitive forearm and hand movements. While it often improves over time, some cases may worsen. Diagnosis involves physical signs, including pain, decreased grip strength, tenderness, and pain during wrist flexion. Medical imaging such as MRI and clinical tests like Mills and Cozen's are used for confirmation.
According to Lenoir, Mares, Carlier (2019), physical therapy is the primary treatment, with exercises like eccentric muscle strengthening, deep friction massage, stretching, ultrasound, and laser therapy proving beneficial. Blood flow restriction training (BFR) has gained interest for enhancing strength and muscle mass. BFR involves partially restricting blood flow using a strap or cuff, inducing muscle hypoxia. Despite the unclear mechanism, BFR has shown positive effects on muscle tissue, possibly related to hypoxia and muscular acidosis.
The lack of studies on BFR's impact, especially on smaller muscle groups like fingers and wrists, creates a need for investigation. Given the commonality and impact of lateral epicondylitis symptoms, this study aims to compare the effectiveness between BFR training with standard PT exercises and standard PT alone in patients with lateral epicondylitis. Thus the purpose of this study is to prove that BFR training is more effective than standard physical training in improving the parameters surrounding tennis elbow.
The participants will be randomized into 2 groups. The standard physical therapy (group1) training consists of :1-ultrasound therapy, 2-laser, 3-deep friction massage followed by ice on the proximal attachment of the extensor tendon, 4-heat, 5-stretching of the wrist flexors and extensors, 6-strengthing of the wrist extensors combined with BFR.
(Group 2) will be treated with the same interventions excluding BFR training. Participants in both groups will be receiving treatment 2 times per week for 12 sessions.
- Being tested
- Blood Flow Restriction Training, Conventional Strength Training
- Keywords
- blood flow restriction training, lateral epicondylitis, tennis elbow
- 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 TrainingOther
The affected limb will have a cuff placed proximally and inflated to occlude the blood flow by 40% attested using a golden standard vascular doppler after which the individuals will perform the strengthening program set forth by the physical therapist. This is preceded by other tennis elbow interventions such as ultrasound, stretching, and deep friction massage at the extensor origin.
Conventional Strength TrainingOther
The individuals in this group will undergo the same conventional physical therapy program as the other group including ultrasound, stretching, and deep friction massage. In addition, they will undergo the same strengthening program set forth by the physical therapist however with no blood flow restriction of any kind.
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Training Group | Experimental | The experimental group will undergo conventional physical therapy including ultrasound, stretching, icing, heat, and deep friction massage applied at the extensor origin. In addition, the experimental group will undergo blood flow restriction strength training including the following: the weight of the dumbbell should be between 20-40% of their 1 rep max. The exercises were targeting the extensor muscles, applied by extending the wrist while holding the dumbbel and exercises targeting the supinator's and pronators while the participants were holding the dumbbell with forearm in neutral position, and were asked to supinate or pronate their forearm.
The cuff will be placed proximally at the affected arm and inflated to achieve 40% limb occlusion depending on size attested using a a golden standard vascular dopler and all blood flow restriction activities were done with a licensed and experienced physical therapist. Receives: Other: Blood Flow Restriction Training |
| Conventional Strength Training Group | Active comparator | The active comparator group will undergo the same interventions as the experimental group with the addition of conventional strength training including the same program as the experimental group but without blood flow restriction of any kind: the weight of the dumbbell should be between 20-40% of their 1 rep max. The exercises were targeting the extensor muscles, applied by extending the wrist while holding the dumbbell for 4 sets (35 repetitions, 15 repetitions,15 repetitions,15 repetitions) respectively, and exercises targeting the supinator's and pronators while the participants were holding the dumbbell with forearm in neutral position, and were asked to supinate or pronate their forearm. Receives: Other: Conventional Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Strength
The hand grip strength was tested using a Camry Dynamometer, which is a smedly spring type dynamomter, whose reliability and validity in measuring handgrip strength has been reported by available literature.
Measured: Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).
Secondary outcomes (2)
Patient Related Tennis Elbow Evaluation Scale (PRTEES)
A scale specifically developed for Lateral Epicondylitis and it was used to determine forearm pain and disability, this scale consists of two parts, namely pain (5 items) and functional activities (10 items), each item has a score from 0 (no pain at all when performing a task) to 10 (the worst pain or unable to perform the task). The total score is the combined score of the 2 parts (OZMEN, KOPARAL, KARATAS... et al 2021), and it is proven that it is a reliable and valid tool for measuring pain and disability in LE patients (Jafarian, Barati, Sadeghi-Demneh 2021)
Measured: Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).
Numerical Pain Rating Scale (NPRS)
A widely used 11-point scale (0-no pain, 10- sever pain) which has been proven to have good test reliability in individuals with chronic pain (Cheatham, Stull, Kobler 2018)
Measured: Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start29 Jun 2024
- Primary completion25 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Factorial
- Model description
- A randomized controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490692
- Sponsor's protocol ID
- BFR Training
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ffect of Blood Flow Restriction Training on Lateral Epicondylitis Parameters in Patients With Tennis Elbow
- ClinicalTrials.gov ID
- NCT06490692
- Acronym / sponsor ID
- BFR Training
- Keywords
- blood flow restriction training, lateral epicondylitis, tennis elbow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Jun 2024 (actual)
- Primary completion
- 25 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 8 Jul 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 goal of this randomized controlled clinical trial is to investigate the effects of blood flow restriction training on the parameters surrounding tennis elbow afflicted patients including pain, disability, and grip strength.
The main question this study aims to answer is:
1- Does blood flow restriction training offer significantly better effects on pain, disability, and grip strength when compared to conventional strength training without blood flow restriction in patients afflicted with tennis elbow? Research will compare two groups with tennis elbow where both will perform the same rehabilitation program consisting of conventional physical therapy for tennis elbow as well as a strength training program with the only difference being that one group will undergo blood flow restriction training while the other will not.
Detailed description
Lateral epicondylitis, commonly known as Tennis elbow, is a musculoskeletal condition characterized by pain at the lateral epicondyle due to repetitive forearm and hand movements. While it often improves over time, some cases may worsen. Diagnosis involves physical signs, including pain, decreased grip strength, tenderness, and pain during wrist flexion. Medical imaging such as MRI and clinical tests like Mills and Cozen's are used for confirmation.
According to Lenoir, Mares, Carlier (2019), physical therapy is the primary treatment, with exercises like eccentric muscle strengthening, deep friction massage, stretching, ultrasound, and laser therapy proving beneficial. Blood flow restriction training (BFR) has gained interest for enhancing strength and muscle mass. BFR involves partially restricting blood flow using a strap or cuff, inducing muscle hypoxia. Despite the unclear mechanism, BFR has shown positive effects on muscle tissue, possibly related to hypoxia and muscular acidosis.
The lack of studies on BFR's impact, especially on smaller muscle groups like fingers and wrists, creates a need for investigation. Given the commonality and impact of lateral epicondylitis symptoms, this study aims to compare the effectiveness between BFR training with standard PT exercises and standard PT alone in patients with lateral epicondylitis. Thus the purpose of this study is to prove that BFR training is more effective than standard physical training in improving the parameters surrounding tennis elbow.
The participants will be randomized into 2 groups. The standard physical therapy (group1) training consists of :1-ultrasound therapy, 2-laser, 3-deep friction massage followed by ice on the proximal attachment of the extensor tendon, 4-heat, 5-stretching of the wrist flexors and extensors, 6-strengthing of the wrist extensors combined with BFR.
(Group 2) will be treated with the same interventions excluding BFR training. Participants in both groups will be receiving treatment 2 times per week for 12 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Training Group | Experimental | Other: Blood Flow Restriction TrainingThe experimental group will undergo conventional physical therapy including ultrasound, stretching, icing, heat, and deep friction massage applied at the extensor origin. In addition, the experimental group will undergo blood flow restriction strength training including the following: the weight of the dumbbell should be between 20-40% of their 1 rep max. The exercises were targeting the extensor muscles, applied by extending the wrist while holding the dumbbel and exercises targeting the supinator's and pronators while the participants were holding the dumbbell with forearm in neutral position, and were asked to supinate or pronate their forearm. The cuff will be placed proximally at the affected arm and inflated to achieve 40% limb occlusion depending on size attested using a a golden standard vascular dopler and all blood flow restriction activities were done with a licensed and experienced physical therapist. |
| Conventional Strength Training Group | Active comparator | Other: Conventional Strength TrainingThe active comparator group will undergo the same interventions as the experimental group with the addition of conventional strength training including the same program as the experimental group but without blood flow restriction of any kind: the weight of the dumbbell should be between 20-40% of their 1 rep max. The exercises were targeting the extensor muscles, applied by extending the wrist while holding the dumbbell for 4 sets (35 repetitions, 15 repetitions,15 repetitions,15 repetitions) respectively, and exercises targeting the supinator's and pronators while the participants were holding the dumbbell with forearm in neutral position, and were asked to supinate or pronate their forearm. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients that were included in this study were diagnosed with lateral epicondylitis by a medical doctor for less than 3 months.
- Dominant hand was diagnosed with lateral epicondylitis.
- They were aged between 20 and 40 years old.
- With decreased grip strength and wrist range of motion.
- No history of physical therapy treatment for lateral epicondylitis for at least 6 months.
Key exclusion criteria (6 listed)
- Patients with chronic diabetes.
- Any type of trauma or fracture in the upper extremities in the last 3 months.
- Patients with any vestibular problems.
- Patients with deep vein thrombosis (DVT).
- Patients with hypertension.
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 TrainingThe affected limb will have a cuff placed proximally and inflated to occlude the blood flow by 40% attested using a golden standard vascular doppler after which the individuals will perform the strengthening program set forth by the physical therapist. This is preceded by other tennis elbow interventions such as ultrasound, stretching, and deep friction massage at the extensor origin. | Other | Blood Flow Restriction Training Group |
| Conventional Strength TrainingThe individuals in this group will undergo the same conventional physical therapy program as the other group including ultrasound, stretching, and deep friction massage. In addition, they will undergo the same strengthening program set forth by the physical therapist however with no blood flow restriction of any kind. | Other | Conventional Strength Training Group |
Primary outcome
Hand Grip Strength
Time frame: Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).
The hand grip strength was tested using a Camry Dynamometer, which is a smedly spring type dynamomter, whose reliability and validity in measuring handgrip strength has been reported by available literature.
2 secondary outcomes
Patient Related Tennis Elbow Evaluation Scale (PRTEES)
Time frame: Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).
Numerical Pain Rating Scale (NPRS)
Time frame: Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Conventional Strength Training in people with Tennis Elbow and Lateral Epicondylitis, run by Cairo University at 1 site in Lebanon.
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 5 inclusion and 6 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 8 Jul 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 Lebanon. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Grip Strength (time frame: Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).). 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 8 Jul 2024.