ECRB TendinopathyNCT06846593

The Comparison of Semiconductor Embedded Therapeutic Arm Sleeves for the Treatment of ECRB Tendinopathy

A study testing Semiconductor Embedded Therapeutic Arm Sleeves and Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections in people with ECRB Tendinopathy, run by INCREDIWEAR HOLDINGS, INC. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded fabric combined with PRP+ASC injections in the affected area. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: ECRB Tendinopathy
What is being tested?: Semiconductor Embedded Therapeutic Arm Sleeves and Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2024to 20 May 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with ECRB tendinopathy as determined by radiographic assessment or ultrasound imaging.
Patients age 18-65
Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
Patients who are willing and able to sign corresponding research subject consent form.

Who cannot join

Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
Patient has had prior surgical treatment of the elbow in the last 5 years or injection treatment(s) in the last 2 years
Patient has complete tear of ECRB tendon or other surgical indication
Patient has chronic pain conditions unrelated to elbow condition
Patient has auto-immune or auto-inflammatory diseases

Show all 12Show fewer

Patient has used tobacco within the last 90 days
Patient is not within the ages of 18-65
Patient has a history of metabolic disorders
Patient has an active infection (local or systemic)
Patient is unwilling or unable to sign the corresponding research subject consent form
Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bluetail Medical Group
Chesterfield, Missouri, 63005

Other trials in United States

About this study

Official title: The Comparison and Combination of Semiconductor Embedded Therapeutic Arm Sleeves and Platelet-Rich Plasma With Adipose Stem Cell (PRP+ASC) Injections for the Treatment of ECRB Tendinopathy (Lateral Epicondylitis): A Randomized, Double-Blinded, Placebo-Controlled Prospective Clinical Trial

Read the detailed description

Extensor Carpi Radialis Brevis (ECRB) tendinopathy, also known as lateral epicondylitis or tennis elbow, is the most prevalent elbow soft tissue injury and affects 1-3% of the population. Repetitive overloading of the tendon and ligaments in the elbow lead to microtraumas, causing abnormal angiofibroblastic remodeling and increased pain. Microtearing occurs most commonly at the origin of the extensor carpi radialis brevis (ECRB) tendon. The main symptoms include a loss of grip strength, a burning sensation near the ECRB origin site, and pain during daily activities such as grasping objects or shaking hands. Both conditions present a significant injury and treatment burden on the population and effective treatment and pain management approaches with minimal side effects are needed.

Novel nonsurgical treatment approaches for ECRB tendinopathy include platelet-rich plasma (PRP) injections and stem cell therapy. Ultrasound-guided PRP and adipose-derived stem cells (ASCs) injections have shown to be an effective treatment option for patients with chronic ECRB tendinopathy.

The proposed study seeks to assess the effect of non-compressive semiconductor embedded arm sleeves in combination with PRP + ASC injections, throughout a 6-month rehabilitation course for patients with ECRB tendinopathy. Outcome measures will be collected at standardized intervals to evaluate and compare treatment groups.

Conditions: ECRB Tendinopathy
Being tested: Semiconductor Embedded Therapeutic Arm Sleeves, Placebo Arm Sleeves, Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections
Keywords: ECRB, lateral epicondylitis, tendinopathy, tennis elbow, extensor carpi radialis brevis, platelet-rich plasma, PRP, stem cell therapy, arm sleeves
Medical subject headings: Tennis Elbow, Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Semiconductor Embedded Therapeutic Arm SleevesDevice
labeled A or B, assigned based on blinded randomization table provided by the sponsor.
Placebo Arm SleevesDevice
labeled A or B, assigned based on blinded randomization table provided by the sponsor.
Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) InjectionsOther
patients will choose or opt out of these standard of care injections.

Study groups in NCT06846593
Study group	Role	What they receive
Incrediwear only	Active comparator	One group will receive active therapy (semiconductor embedded arm sleeve) "Incrediwear only" Receives: Device: Semiconductor Embedded Therapeutic Arm Sleeves
Sham Incrediwear	Sham comparator	One group will receive placebo therapy (arm sleeve absent of semiconductor thread) "Sham Incrediwear" Receives: Device: Placebo Arm Sleeves
Incrediwear with PRP+ASC injections	Active comparator	One group will receive active therapy with SOC (standard of care) PRP+ASC injections (active semiconductor embedded arm sleeves after they have received PRP+ ASC injections as part of their routine care) "Incrediwear with SOC PRP+ASC injections" Receives: Device: Semiconductor Embedded Therapeutic Arm Sleeves; Other: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections
Sham Incrediwear with PRP+ASC injections	Sham comparator	One group will receive placebo therapy with SOC (standard of care) PRP+ASC injections (arm sleeve absent of semiconductor fabric after they have received PRP+ASC injections as part of their routine care) "Sham Incrediwear with SOC PRP+ASC injections" Receives: Device: Placebo Arm Sleeves; Other: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in patient elbow function and pain as determined by the Patient-Rated Tennis Elbow Evaluation (PRTEE).
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-administered questionnaire that assesses elbow pain and functional ability in patients with tennis elbow. The minimum number is zero meaning no pain and the maximum number is 10 meaning the worst imaginable pain. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain and minimal functional ability
Measured: 6 months

Secondary outcomes (3)

Change in pain as determined by the Visual Analog Scale (VAS).
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The minimum number is zero meaning no pain and maximum number is 10 meaning the most pain the patient has every felt in their entire life. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain.
Measured: 6 months
Change in patient elbow function as determined by the Disabilities of the Arm, Shoulder, and Hand (DASH).
The Disabilities of the Arm, Shoulder, and Hand (DASH) is a self-administered questionnaire that assesses the patient's functional ability and arm, shoulder, or hand pain. It is on a 5-point likert scale with 1= No difficulty, 2 = Mild difficulty, 3 = Moderate difficulty, 4 = Severe difficulty, and 5 = Unable. The score ranges from 0 to 100, with higher scores indicating greater disability.
Measured: 6 months
Change in grip strength as measured by a hand dynamometer
Patient's grip strength will be assessed with a hand dynamometer. The patient will squeeze the device with the patient's elbow at 90 degrees of flexion and wrist in 30 degrees of extension. A force output value in pounds (lbs) will be displayed and a higher number of force output indicates a stronger grip strength.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202420 May 2026

First posted26 Feb 2025
Study start1 Nov 2024
Primary completion16 Sep 2025
Study completion20 May 2026

Why it stopped: Not enough patients to enroll at the site

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for ECRB TendinopathyStudies 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
Model description: Subjects will determine whether they would like to receive Standard of Care (SOC) PRP+ASC injections. Then, the subjects will be randomly assigned to the study group in which they will receive a real or sham semiconductor embedded sleeve. The subjects will be instructed to wear the sleeve for a minimum of 12 hours per day, including overnight, for the entire duration of the study.
Masking: Single blind
Who is masked: Participant
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06846593
Sponsor's protocol ID: WCG IRB Protocol #20242832
Other IDs: 2024-06
Status last verified: May 2026
First submitted: 13 Nov 2024
Last updated: 22 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be stored and used for the duration of time required to conduct analysis and publish all proposed peer-reviewed papers, according to study objectives. Data will be retained for 2 years after publication to allow for re-analysis that may be initiated in response to readers/reviewers. Subject records will be maintained at the PI's clinical site for a minimum of 7 years following latest study follow-up.

Publications

Bisset LM, Collins NJ, Offord SS. Immediate effects of 2 types of braces on pain and grip strength in people with lateral epicondylalgia: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):120-8. doi: 10.2519/jospt.2014.4744. Epub 2014 Jan 9.
PubMed 24405258
Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993 Nov;55(2):195-203. doi: 10.1016/0304-3959(93)90148-I.
PubMed 8309709
Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.
PubMed 17254903
Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.
PubMed 11382253
Cho SY, Roh YS, Roh HT. Evaluation of tympanic temperature and thermal sensation responses during exercise to verify the positive effects of wearing germanium-coated functional clothing. J Phys Ther Sci. 2016 Jun;28(6):1860-3. doi: 10.1589/jpts.28.1860. Epub 2016 Jun 28.
PubMed 27390434
Kyselovic J, Masarik J, Kechemir H, Koscova E, Turudic II, Hamblin MR. Physical properties and biological effects of ceramic materials emitting infrared radiation for pain, muscular activity, and musculoskeletal conditions. Photodermatol Photoimmunol Photomed. 2023 Jan;39(1):3-15. doi: 10.1111/phpp.12799. Epub 2022 May 21.
PubMed 35510621
Park JH, Lee S, Cho DH, Park YM, Kang DH, Jo I. Far-infrared radiation acutely increases nitric oxide production by increasing Ca(2+) mobilization and Ca(2+)/calmodulin-dependent protein kinase II-mediated phosphorylation of endothelial nitric oxide synthase at serine 1179. Biochem Biophys Res Commun. 2013 Jul 12;436(4):601-6. doi: 10.1016/j.bbrc.2013.06.003. Epub 2013 Jun 10.
PubMed 23756809
Leung TK. In Vitro and In Vivo Studies of the Biological Effects of Bioceramic (a Material of Emitting High Performance Far-Infrared Ray) Irradiation. Chin J Physiol. 2015 Jun 30;58(3):147-55. doi: 10.4077/CJP.2015.BAD294.
PubMed 26014120
Duranti C, Bagni G, Iorio J, Colasurdo R, Devescovi V, Arcangeli A. Effects of Germanium embedded fabric on the chondrogenic differentiation of adipose derived stem cells. Tissue Cell. 2024 Oct;90:102507. doi: 10.1016/j.tice.2024.102507. Epub 2024 Jul 30.
PubMed 39128191
Justice TE, Jacob PB. Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study. J Orthop. 2023 Nov 24;49:102-106. doi: 10.1016/j.jor.2023.11.044. eCollection 2024 Mar.
PubMed 38094981
Vatansever F, Hamblin MR. Far infrared radiation (FIR): its biological effects and medical applications. Photonics Lasers Med. 2012 Nov 1;4:255-266. doi: 10.1515/plm-2012-0034.
PubMed 23833705
Marino K, Lee R, Lee P. Effect of Germanium-Embedded Knee Sleeve on Osteoarthritis of the Knee. Orthop J Sports Med. 2019 Oct 25;7(10):2325967119879124. doi: 10.1177/2325967119879124. eCollection 2019 Oct.
PubMed 31696136
Masiello F, Pati I, Veropalumbo E, Pupella S, Cruciani M, De Angelis V. Ultrasound-guided injection of platelet-rich plasma for tendinopathies: a systematic review and meta-analysis. Blood Transfus. 2023 Mar;21(2):119-136. doi: 10.2450/2022.0087-22. Epub 2022 Oct 17.
PubMed 36346880
Lee SY, Kim W, Lim C, Chung SG. Treatment of Lateral Epicondylosis by Using Allogeneic Adipose-Derived Mesenchymal Stem Cells: A Pilot Study. Stem Cells. 2015 Oct;33(10):2995-3005. doi: 10.1002/stem.2110. Epub 2015 Aug 6.
PubMed 26202898
Khoury M, Tabben M, Rolon AU, Levi L, Chamari K, D'Hooghe P. Promising improvement of chronic lateral elbow tendinopathy by using adipose derived mesenchymal stromal cells: a pilot study. J Exp Orthop. 2021 Jan 26;8(1):6. doi: 10.1186/s40634-020-00320-z.
PubMed 33501619

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparison and Combination of Semiconductor Embedded Therapeutic Arm Sleeves and Platelet-Rich Plasma With Adipose Stem Cell (PRP+ASC) Injections for the Treatment of ECRB Tendinopathy (Lateral Epicondylitis): A Randomized, Double-Blinded, Placebo-Controlled Prospective Clinical Trial
ClinicalTrials.gov ID: NCT06846593
Acronym / sponsor ID: WCG IRB Protocol #20242832
Conditions: ECRB Tendinopathy
Keywords: ECRB, lateral epicondylitis, tendinopathy, tennis elbow, extensor carpi radialis brevis, platelet-rich plasma, PRP, stem cell therapy
Study type: Interventional
Recruitment status: TerminatedReason stopped: Not enough patients to enroll at the site
Enrolment: 5 participants (actual)
Lead sponsor: INCREDIWEAR HOLDINGS, INC.Industry (pharma, biotech, devices)
Study start: 1 Nov 2024 (actual)
Primary completion: 16 Sep 2025 (actual)
Study completion: 20 May 2026 (actual)
First posted: 26 Feb 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: Subjects will determine whether they would like to receive Standard of Care (SOC) PRP+ASC injections. Then, the subjects will be randomly assigned to the study group in which they will receive a real or sham semiconductor embedded sleeve. The subjects will be instructed to wear the sleeve for a minimum of 12 hours per day, including overnight, for the entire duration of the study.

Arm	Type	Receives
Incrediwear only	Active comparator	Device: Semiconductor Embedded Therapeutic Arm SleevesOne group will receive active therapy (semiconductor embedded arm sleeve) "Incrediwear only"
Sham Incrediwear	Sham comparator	Device: Placebo Arm SleevesOne group will receive placebo therapy (arm sleeve absent of semiconductor thread) "Sham Incrediwear"
Incrediwear with PRP+ASC injections	Active comparator	Device: Semiconductor Embedded Therapeutic Arm Sleeves, Other: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) InjectionsOne group will receive active therapy with SOC (standard of care) PRP+ASC injections (active semiconductor embedded arm sleeves after they have received PRP+ ASC injections as part of their routine care) "Incrediwear with SOC PRP+ASC injections"
Sham Incrediwear with PRP+ASC injections	Sham comparator	Device: Placebo Arm Sleeves, Other: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) InjectionsOne group will receive placebo therapy with SOC (standard of care) PRP+ASC injections (arm sleeve absent of semiconductor fabric after they have received PRP+ASC injections as part of their routine care) "Sham Incrediwear with SOC PRP+ASC injections"

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients diagnosed with ECRB tendinopathy as determined by radiographic assessment or ultrasound imaging.
Patients age 18-65
Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
Patients who are willing and able to sign corresponding research subject consent form.

Key exclusion criteria (12 listed)

Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
Patient has had prior surgical treatment of the elbow in the last 5 years or injection treatment(s) in the last 2 years
Patient has complete tear of ECRB tendon or other surgical indication
Patient has chronic pain conditions unrelated to elbow condition

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
Semiconductor Embedded Therapeutic Arm Sleeveslabeled A or B, assigned based on blinded randomization table provided by the sponsor.	Device	Incrediwear only, Incrediwear with PRP+ASC injections
Placebo Arm Sleeveslabeled A or B, assigned based on blinded randomization table provided by the sponsor.	Device	Sham Incrediwear, Sham Incrediwear with PRP+ASC injections
Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injectionspatients will choose or opt out of these standard of care injections.	Other	Incrediwear with PRP+ASC injections, Sham Incrediwear with PRP+ASC injections

Primary outcome

Change in patient elbow function and pain as determined by the Patient-Rated Tennis Elbow Evaluation (PRTEE).
Time frame: 6 months
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-administered questionnaire that assesses elbow pain and functional ability in patients with tennis elbow. The minimum number is zero meaning no pain and the maximum number is 10 meaning the worst imaginable pain. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain and minimal functional ability

3 secondary outcomes

Change in pain as determined by the Visual Analog Scale (VAS).
Time frame: 6 months
Change in patient elbow function as determined by the Disabilities of the Arm, Shoulder, and Hand (DASH).
Time frame: 6 months
Change in grip strength as measured by a hand dynamometer
Time frame: 6 months

Results and safety

The study was stopped early (reason given: Not enough patients to enroll at the site). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Background: PubMed 24405258Bisset LM, Collins NJ, Offord SS. Immediate effects of 2 types of braces on pain and grip strength in people with lateral epicondylalgia: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):120-8. doi: 10.2519/jospt.2014.4744. Epub 2014 Jan 9.
Background: PubMed 8309709Jensen MP, McFarland CA. Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain. 1993 Nov;55(2):195-203. doi: 10.1016/0304-3959(93)90148-I.
Background: PubMed 17254903Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.
Background: PubMed 11382253Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.
Background: PubMed 27390434Cho SY, Roh YS, Roh HT. Evaluation of tympanic temperature and thermal sensation responses during exercise to verify the positive effects of wearing germanium-coated functional clothing. J Phys Ther Sci. 2016 Jun;28(6):1860-3. doi: 10.1589/jpts.28.1860. Epub 2016 Jun 28.
Background: PubMed 35510621Kyselovic J, Masarik J, Kechemir H, Koscova E, Turudic II, Hamblin MR. Physical properties and biological effects of ceramic materials emitting infrared radiation for pain, muscular activity, and musculoskeletal conditions. Photodermatol Photoimmunol Photomed. 2023 Jan;39(1):3-15. doi: 10.1111/phpp.12799. Epub 2022 May 21.
Background: PubMed 23756809Park JH, Lee S, Cho DH, Park YM, Kang DH, Jo I. Far-infrared radiation acutely increases nitric oxide production by increasing Ca(2+) mobilization and Ca(2+)/calmodulin-dependent protein kinase II-mediated phosphorylation of endothelial nitric oxide synthase at serine 1179. Biochem Biophys Res Commun. 2013 Jul 12;436(4):601-6. doi: 10.1016/j.bbrc.2013.06.003. Epub 2013 Jun 10.
Background: PubMed 26014120Leung TK. In Vitro and In Vivo Studies of the Biological Effects of Bioceramic (a Material of Emitting High Performance Far-Infrared Ray) Irradiation. Chin J Physiol. 2015 Jun 30;58(3):147-55. doi: 10.4077/CJP.2015.BAD294.
Background: PubMed 39128191Duranti C, Bagni G, Iorio J, Colasurdo R, Devescovi V, Arcangeli A. Effects of Germanium embedded fabric on the chondrogenic differentiation of adipose derived stem cells. Tissue Cell. 2024 Oct;90:102507. doi: 10.1016/j.tice.2024.102507. Epub 2024 Jul 30.
Background: PubMed 38094981Justice TE, Jacob PB. Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study. J Orthop. 2023 Nov 24;49:102-106. doi: 10.1016/j.jor.2023.11.044. eCollection 2024 Mar.
Background: PubMed 23833705Vatansever F, Hamblin MR. Far infrared radiation (FIR): its biological effects and medical applications. Photonics Lasers Med. 2012 Nov 1;4:255-266. doi: 10.1515/plm-2012-0034.
Background: PubMed 31696136Marino K, Lee R, Lee P. Effect of Germanium-Embedded Knee Sleeve on Osteoarthritis of the Knee. Orthop J Sports Med. 2019 Oct 25;7(10):2325967119879124. doi: 10.1177/2325967119879124. eCollection 2019 Oct.
Empowering Recovery: Surface Electromyography Shows how Incrediwear Helps Professional Athletes RecoverLink provided by the sponsor.
Individual participant dataSharing planned: No. Data will be stored and used for the duration of time required to conduct analysis and publish all proposed peer-reviewed papers, according to study objectives. Data will be retained for 2 years after publication to allow for re-analysis that may be initiated in response to readers/reviewers. Subject records will be maintained at the PI's clinical site for a minimum of 7 years following latest study follow-up.

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.

Dr. Matthew Bayes, MD, Medical principal investigator

Bluetail Medical Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: stopped early, as of the sponsor's last update on 22 May 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 United States. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Not enough patients to enroll at the site). Results are not available in the source record.

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?

Change in patient elbow function and pain as determined by the Patient-Rated Tennis Elbow Evaluation (PRTEE). (time frame: 6 months). 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 NCT06846593, which also lists 19 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 22 May 2026.