TenoMiR for Tennis Elbow

Recruiting at 8 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Causeway Therapeutics

Must not be taking: Pain medications, Glucocorticoids

Disqualifiers: Corticosteroid injection, PRP injection, surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

123 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking pain medications like opiates or NSAIDs at least 1 week before starting the trial. If you are using medications that affect the skeleton, you may also need to stop those.

Will I have to stop taking my current medications?

You will need to stop taking pain medications like opiates or NSAIDs at least one week before starting the trial. If you are using medications that affect the skeleton, you may also need to stop those.

What data supports the idea that TenoMiR for Tennis Elbow is an effective treatment?

The available research does not provide specific data on the effectiveness of TenoMiR for Tennis Elbow. Instead, it includes studies on other treatments like electroacupuncture, vibration therapy, and physical therapy for Tennis Elbow. Without direct data on TenoMiR, we cannot conclude its effectiveness compared to these other treatments. ^{1 2 3 4 5}

What safety data exists for TenoMiR treatment for tennis elbow?

The provided research does not contain any safety data for TenoMiR, TenoMiR, or CWT-001. The studies focus on other treatments and topics related to tennis elbow, such as incobotulinumtoxinA injections, musculoskeletal injuries in real tennis, and kinesiotaping effects. Therefore, no specific safety data for TenoMiR is available in the given research. ^{1 6 7 8 9}

Is TenoMiR a promising treatment for tennis elbow?

Yes, TenoMiR is considered a promising treatment for tennis elbow because it offers potential relief from pain and improved function for those suffering from this condition. ^{10 11 12 13 14}

What is the purpose of this trial?

This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. The study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible. The study drug has been tested in humans in an earlier study, and appeared to be safe and well-tolerated. This study aims to test the study drug in a larger number of participants.

Eligibility Criteria

This trial is for individuals with tennis elbow who are otherwise healthy. They must have symptoms like tenderness at the lateral epicondyle and a positive 'pick up back of chair' sign, despite treatments like splinting, NSAIDs, or physical therapy.

Inclusion Criteria

Subject is otherwise healthy as determined by a responsible physician

My symptoms appear when I twist my forearm or bend my wrist back.

My symptoms have lasted 6 weeks to 6 months despite trying physical therapy, splinting, and NSAIDs.

Exclusion Criteria

I can stop taking pain medication a week before starting the trial medication.

I have had a Platelet-Rich Plasma injection in my elbow.

I use or recently used medication that affects my bones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intralesional injection of TenoMiR or a sham comparator

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, disability, and tendon integrity

90 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• TenoMiR

Trial Overview The study tests TenoMiR, a new drug aimed at improving collagen quality to repair elbow damage. It's compared against a saline injection (placebo). The goal is to offer an effective treatment right after diagnosis for quicker recovery.

Participant Groups

Group I: TenoMiR intralesional injection Experimental Treatment 1 Intervention

Drug: TenoMiR (Low Dose), Single injection Mimic of miR29a Other Names: • CWT-001 Drug: TenoMiR (High Dose), Single injection Mimic of miR29a Other Names: • CWT-001

Group II: 0.9% saline subcutaneous sham injection Placebo Group 1 Intervention

Drug: 0.9% saline Subcutaneous single injection

Who Is Running the Clinical Trial?

Causeway Therapeutics

Lead Sponsor

Trials

2

Recruited

150+

Findings from Research

The Greek version of the Patient-Rated Tennis Elbow Evaluation (PRTEE-G) Questionnaire has been validated as a reliable tool for assessing Lateral Elbow Tendinopathy (LET) in 82 patients, showing excellent test-retest reliability (ICC = 0.94).

The PRTEE-G demonstrated strong internal consistency (Cronbach's alpha = 0.95) and good concurrent validity when correlated with the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), indicating it effectively measures the impact of LET on patients' daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greek adaptation and validation of the Patient-Rated Tennis Elbow Evaluation (PRTEE). Stasinopoulos, D., Papadopoulos, C., Antoniadou, M., et al.[2015]

In a study of 128 patients with tennis elbow, the treatment group receiving electroacupuncture and moxibustion showed a higher cure rate (40.6%) and effective rate (93.7%) compared to the control group treated with lidocaine and prednisone (cure rate of 25.0% and effective rate of 78.1%).

The results indicate that electroacupuncture combined with moxibustion is a more effective treatment option for tennis elbow than conventional steroid injections, suggesting a promising alternative for patients seeking relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Controlled observation on electroacupuncture combined with cake-separated moxibustion for treatment of tennis elbow]. Jiang, ZY., Li, CD., Guo, JH., et al.[2018]

Patients with chronic unilateral tennis elbow exhibited significantly slower reaction times (19% to 36% slower) and reduced speed of movement (31% to 32% slower) in their arms compared to age- and gender-matched controls, indicating impaired motor performance.

Interestingly, the healthy arms of the patients also showed slower reaction times and movement speed compared to the controls, suggesting that the effects of chronic tennis elbow may extend beyond the injured arm, potentially indicating a broader motor performance issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilaterally decreased motor performance of arms in patients with chronic tennis elbow. Pienimäki, TT., Kauranen, K., Vanharanta, H.[2019]

In a study of 54 patients with tennis elbow, the addition of a high-frequency vibration device (Tenease™) to standard treatment did not show statistically significant improvements in pain and function compared to standard treatment alone after 6 months.

Both treatment groups experienced improvements in their condition, but the Tenease group did not outperform the standard treatment group, and the study faced challenges such as a high dropout rate and a small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration therapy versus standard treatment for tennis elbow: A randomized controlled study. Furness, ND., Phillips, A., Gallacher, S., et al.[2019]

In a study of 83 patients undergoing 8 weeks of physical therapy for lateral epicondylitis, it was found that women and those reporting nerve symptoms had poorer outcomes, as measured by the DASH questionnaire and pain visual analog scale.

Factors such as work-related onset, repetitive keyboarding jobs, and cervical joint signs were particularly influential in predicting worse outcomes for women, highlighting the need for tailored interventions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with prognosis of lateral epicondylitis after 8 weeks of physical therapy. Waugh, EJ., Jaglal, SB., Davis, AM., et al.[2019]

In a study of 24 adult patients with lateral epicondylitis who did not respond to other treatments, ultrasound-guided injections of incobotulinumtoxinA significantly reduced pain and improved upper-limb functionality over 6 months, with results showing improvement at all follow-up points (p < 0.001).

The treatment was found to be safe, with no serious adverse events reported, aside from expected mild weakness in the third finger, indicating that incobotulinumtoxinA could be a viable option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Ultrasound-Guided Administration of Botulinum Toxin (IncobotulinumtoxinA) in Patients with Lateral Epicondylitis. Galván Ruiz, A., Vergara Díaz, G., Rendón Fernández, B., et al.[2020]

This study recorded 662 musculoskeletal injuries among 485 real tennis players, revealing an incidence rate of 0.4 injuries per 1000 hours of play, with the elbow, knee, and face being the most commonly injured areas.

The majority of upper limb injuries were gradual in onset, while lower limb injuries were often sudden, indicating different injury mechanisms that could inform prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Musculoskeletal injuries in real tennis. Humphrey, JA., Humphrey, PP., Greenwood, AS., et al.[2020]

In a study of 48 patients with chronic lateral epicondylitis, both kinesiotaping (KT) and sham taping significantly improved pain and arm function, indicating that both methods can provide relief.

However, there was no significant difference in effectiveness between the KT and sham groups, suggesting that the benefits of KT may not be superior to a placebo effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of kinesiotaping on wrist extensor strength using an isokinetic device in patients with chronic lateral epicondylitis: A randomized-controlled trial. Tezel, N., Can, A., Karaahmet, Ö., et al.[2022]

A study of 267 new cases of tennis elbow found that manual job tasks significantly increase the risk of developing the condition, with an odds ratio of 3.1, indicating a strong association with physical strain factors like posture and forceful work.

Women with low social support at work were found to have a higher risk of tennis elbow (odds ratio 2.4), highlighting the importance of psychosocial factors alongside physical risks in the development of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and psychosocial risk factors for lateral epicondylitis: a population based case-referent study. Haahr, JP., Andersen, JH.[2019]

The simulation model revealed that off-centre impacts during one-handed tennis backhands can significantly increase wrist flexion and extension torque, potentially leading to injuries like tennis elbow.

A tighter grip on the racquet during off-centre impacts exacerbates these effects, resulting in less racquet rotation and increased wrist extension torque, highlighting the importance of grip technique in injury prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of ball impact location and grip tightness on the arm, racquet and ball for one-handed tennis backhand groundstrokes. King, MA., Kentel, BB., Mitchell, SR.[2012]

In a study involving 27 participants with lateral elbow tendinopathy, the application of tensioned multidirectional elastic tape did not show statistically significant improvements in pain-free grip strength or pressure pain threshold compared to control conditions.

Despite the overall lack of significant results, 26% of participants did experience an increase in pain-free grip strength after using the elastic tape, suggesting that individual responses may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multidirectional elastic tape on pain and function in individuals with lateral elbow tendinopathy: A randomised crossover trial. Hill, CE., Heales, LJ., Stanton, R., et al.[2023]

The Marcy Wedge-Pro (MWP) device effectively measures wrist extension exercises in patients with tennis elbow, a common condition characterized by pain during this activity.

The MWP demonstrated a significant ability to accurately identify patients who responded to treatment, suggesting it could be a valuable tool for quantitatively assessing tennis elbow outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of tennis elbow using the Marcy Wedge-Pro. Smith, RW., Mani, R., Cawley, MI., et al.[2019]

A study involving 24 tennis players showed that different racket constructions can significantly affect arm vibrations during play, with some rackets reducing vibrations by nearly threefold, which may help prevent conditions like tennis elbow.

Factors such as body weight and skill level also influence vibration levels, with less skilled players experiencing higher vibration loads, indicating that both equipment choice and player experience are important in managing arm stress during tennis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfer of tennis racket vibrations onto the human forearm. Hennig, EM., Rosenbaum, D., Milani, TL.[2004]

The patient-related forearm evaluation questionnaire (PRFEQ) demonstrated excellent test-retest reliability for assessing pain and function in patients with lateral epicondylitis, with overall reliability scores of ICC 0.89 for the full questionnaire and ICC 0.83 for the function subscale.

While the PRFEQ is a reliable tool for evaluating forearm pain and function, its large standard error of measurement and confidence intervals suggest it may not accurately predict individual patient scores, particularly for those with work-related lateral epicondylitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of a patient-rated forearm evaluation questionnaire for patients with lateral epicondylitis. Overend, TJ., Wuori-Fearn, JL., Kramer, JF., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Greek adaptation and validation of the Patient-Rated Tennis Elbow Evaluation (PRTEE). [2015]

2. China pubmed.ncbi.nlm.nih.gov

[Controlled observation on electroacupuncture combined with cake-separated moxibustion for treatment of tennis elbow]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Bilaterally decreased motor performance of arms in patients with chronic tennis elbow. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Vibration therapy versus standard treatment for tennis elbow: A randomized controlled study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Factors associated with prognosis of lateral epicondylitis after 8 weeks of physical therapy. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Ultrasound-Guided Administration of Botulinum Toxin (IncobotulinumtoxinA) in Patients with Lateral Epicondylitis. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Musculoskeletal injuries in real tennis. [2020]

8. Turkey pubmed.ncbi.nlm.nih.gov

The effects of kinesiotaping on wrist extensor strength using an isokinetic device in patients with chronic lateral epicondylitis: A randomized-controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Physical and psychosocial risk factors for lateral epicondylitis: a population based case-referent study. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The effects of ball impact location and grip tightness on the arm, racquet and ball for one-handed tennis backhand groundstrokes. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Effects of multidirectional elastic tape on pain and function in individuals with lateral elbow tendinopathy: A randomised crossover trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Assessment of tennis elbow using the Marcy Wedge-Pro. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Transfer of tennis racket vibrations onto the human forearm. [2004]

14. United States pubmed.ncbi.nlm.nih.gov

Reliability of a patient-rated forearm evaluation questionnaire for patients with lateral epicondylitis. [2019]