Connective Tissue Matrix vs Steroid Injections for Rotator Cuff Tendinopathy

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Must not be taking: Chronic steroids

Disqualifiers: Adhesive capsulitis, Joint instability, others

Compensation: Varies

Number of Visits: 4

Duration: 1 day

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether Connective Tissue Matrix (a natural tissue supplement) or a steroid injection better treats rotator cuff tendinopathy, a condition causing shoulder pain and limited movement. Participants will receive one of these treatments through random selection, and neither they nor the researchers will know which treatment is administered, ensuring unbiased results. Eligible participants are those experiencing shoulder issues due to rotator cuff tendinopathy and willing to receive an injection as part of their treatment. As an unphased trial, this study offers the opportunity to contribute to valuable research that could enhance treatment options for rotator cuff tendinopathy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a history of chronic steroid treatment, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Connective Tissue Matrix (CTM) is generally safe for people. Previous studies have not identified any major safety issues or serious side effects from its use. The CTM, a type of allograft made from human tissue, is designed for injection to help repair or replace damaged tissue.

Corticosteroids, such as Kenalog-40 used in the trial, commonly treat inflammation and are known to be safe when used properly. Some individuals might experience side effects, including temporary pain at the injection site or mood changes.

Overall, past research suggests both treatments in the trial are safe. However, discussing any concerns or questions with the study team or a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for rotator cuff tendinopathy, which often involve corticosteroid injections to reduce inflammation, the CTM Boost treatment uses a novel approach with a decellularized Human Cellular and Tissue Based Allograft derived from placental connective tissue. This innovative treatment is designed to supplement or replace damaged connective tissue rather than just addressing inflammation. Researchers are excited about CTM Boost because it offers a new mechanism of action by potentially enhancing tissue repair and regeneration, which could lead to more sustainable improvements in shoulder function and pain relief. Additionally, the use of biological materials in this way may reduce some of the side effects associated with long-term steroid use.

What evidence suggests that this trial's treatments could be effective for rotator cuff tendinopathy?

Research has shown that Connective Tissue Matrix (CTM), a treatment under study in this trial, might aid tendon repair by creating a supportive environment for cell growth and healing. Early results suggest that CTM can reduce pain and improve movement in individuals with rotator cuff problems by forming a framework that facilitates tissue repair. This trial will compare CTM to corticosteroid injections, another treatment option often used to reduce swelling and provide short-term pain relief for similar issues. However, steroids may not support long-term healing as effectively as CTM. Overall, current evidence suggests that CTM is a promising option for treating rotator cuff tendinopathy. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with rotator cuff tendinopathy, a shoulder condition. Participants must meet certain health criteria to join but the specific inclusion and exclusion details are not provided here.

Inclusion Criteria

My doctor recommends a corticosteroid or CTM injection, and I agree to have it.

Exclusion Criteria

I have been diagnosed with frozen shoulder.

I have shoulder issues including joint impingement or significant wear and tear.

Patients who are pregnant or breast feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either Connective Tissue Matrix or Kenalog-40 corticosteroid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including physical exams and questionnaires

6 months

3 visits (in-person) at 6 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Connective Tissue Matrix
• Corticosteroid

Trial Overview The study compares two treatments for shoulder pain from rotator cuff tendinopathy: an injection of Connective Tissue Matrix (CTM) versus a standard steroid shot. Patients will be randomly assigned to one of these treatments without knowing which one they receive.

How Is the Trial Designed?

Group I: CTM Boost Experimental Treatment 1 Intervention

TM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection. Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

Group II: Corticosteroid Placebo Group 1 Intervention

Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials

52

Recruited

13,000+

CTM Biomedical

Industry Sponsor

Trials

5

Recruited

200+

Published Research Related to This Trial

Intralesional platelet-rich plasma (PRP) injections significantly reduced tear size in partial-thickness rotator cuff tears compared to subacromial corticosteroid (CS) injections, with PRP showing a reduction of 3.39 mm in the coronal plane and 2.97 mm in the sagittal plane.

Patients receiving PRP also experienced better functional improvements in shoulder scores after 6 months compared to those receiving CS injections, indicating that PRP may be a more effective treatment option for enhancing recovery in these injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Platelet-Rich Plasma in Tear Size Reduction in Partial-Thickness Tear of the Supraspinatus Tendon Compared to Corticosteroids Injection. Tanpowpong, T., Thepsoparn, M., Numkarunarunrote, N., et al.[2023]

In a study involving 60 rats, a single dose of corticosteroid (methylprednisolone) did not change the acute response of injured rotator cuff tendons, as measured by collagen expression ratios, indicating that it does not negatively affect the healing process after injury.

Interestingly, the corticosteroid treatment alone (without injury) caused a significant increase in the type-III to type-I collagen expression ratio, suggesting that corticosteroids can mimic an injury response in healthy tendons, but this effect is temporary and returns to baseline within three weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of corticosteroid on collagen expression in injured rotator cuff tendon. Wei, AS., Callaci, JJ., Juknelis, D., et al.[2022]

In a study of 62 patients with chronic elbow tendinopathy, a medicated plaster containing betamethasone valerate significantly reduced pain compared to a placebo, with a mean reduction in pain score of -39.35 mm for the 12-hour application and -36.91 mm for the 24-hour application.

The BMV plaster was found to be safe and well tolerated, with similar local tolerability to the placebo and few treatment-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of betamethasone valerate medicated plaster on painful chronic elbow tendinopathy: a double-blind, randomized, placebo-controlled trial. Frizziero, A., Causero, A., Bernasconi, S., et al.[2020]

In a study of 80 patients undergoing arthroscopic rotator cuff repair, a subacromial injection of sodium hyaluronate/carboxymethylated cellulose (HA/CMC) showed a trend towards faster recovery of shoulder forward flexion at 2 weeks post-surgery, although this was not statistically significant.

The injection did not lead to any complications or adverse effects on rotator cuff healing, suggesting it is a safe option, but further research is needed to confirm its effectiveness in reducing postoperative shoulder stiffness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of subacromial anti-adhesive agent injection after arthroscopic rotator cuff repair: prospective randomized comparison study. Oh, CH., Oh, JH., Kim, SH., et al.[2022]

In a study of 230 patients with subacromial impingement, those who received three or more corticosteroid injections showed no significant increase in the incidence of rotator cuff tears compared to those who received fewer than three injections.

The findings suggest that repeated corticosteroid injections into the subacromial space do not contribute to the risk of rotator cuff damage, indicating that their use can be considered safe in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between rotator cuff tears and repeated subacromial steroid injections: a case-controlled study. Bhatia, M., Singh, B., Nicolaou, N., et al.[2022]

Corticosteroids (CS) significantly decreased cell proliferation in human tendon fibroblasts and led to apoptosis of tendon fibroblasts in rats, indicating a negative impact on tendon healing.

In contrast, hyaluronic acid (HA) did not cause cell death and was associated with better biomechanical strength in treated tendons compared to those treated with CS, suggesting HA may be a safer option for promoting tendon healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of corticosteroids and hyaluronic acid on torn rotator cuff tendons in vitro and in rats. Nakamura, H., Gotoh, M., Kanazawa, T., et al.[2022]

In a study involving 25 female Sprague-Dawley rats, repeated subacromial corticosteroid injections (methylprednisolone and betamethasone) led to harmful changes in the rotator cuff tendons, including abnormal softness and fragmentation of collagen bundles.

The findings suggest that frequent steroid injections for conditions like subacromial impingement syndrome may be detrimental, as 43% of rats treated with methylprednisolone and 71% with betamethasone showed significant structural damage to their tendons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of methylprednisolone and betamethasone injections on the rotator cuff: an experimental study in rats. Akpinar, S., Hersekli, MA., Demirors, H., et al.[2022]

Corticosteroid injections into the subacromial-subdeltoid bursa significantly reduced pain in patients with chronic subacromial bursitis compared to both hyaluronic acid and normal saline, with a notable difference in pain scores at eight weeks.

Hyaluronic acid injections showed only marginal improvement over normal saline, indicating that corticosteroids are the more effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the corticosteroid injection and hyaluronate in the treatment of chronic subacromial bursitis: A randomized controlled trial. Hsieh, LF., Lin, YJ., Hsu, WC., et al.[2022]

Corticosteroid injections, commonly used in nonoperative treatment for rotator cuff conditions, may negatively impact tissue quality, which could affect surgical outcomes.

The effectiveness of steroid injections as a treatment option is not strongly supported by evidence, and factors like chronicity of the tear and tobacco use also play significant roles in the success of rotator cuff repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Steroid Injections Prior to Arthroscopic Rotator Cuff Repair-Is It Time to Rethink a Conservative Treatment Paradigm? Woolf, SK.[2019]

In a study of 49 patients with rotator cuff tendinopathy treated with subacromial corticosteroid injections, 40% of patients failed conservative treatment after an average follow-up of 22.4 months, indicating a significant failure rate.

The success of corticosteroid injections varied by gender, with a success rate of 76.2% in males compared to 45% in females, suggesting that gender may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of success of corticosteroid injection for the management of rotator cuff disease. Contreras, F., Brown, HC., Marx, RG.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06160427

NCT06160427 | Connective Tissue Matrix for Rotator Cuff ... The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff ...

2. ctv.veeva.com ctv.veeva.com/study/connective-tissue-matrix-ctm-for-rotator-cuff-tendinopathy

Connective Tissue Matrix for Rotator Cuff Tendinopathy The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06712290

Connective Tissue Matrix Compared to Steroid Injections ... The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11048385/

Safety and Efficacy of Wharton's Jelly Connective Tissue ... The overall objective of this study is to evaluate the improvement of patient-reported pain scales after applying Wharton's Jelly (WJ) in rotator cuff defects.

5. biolscigroup.us biolscigroup.us/articles/JBM-6-130.pdf

Flowable placental connective tissue matrices for tendon ... FP-CTMs can enhance tendon repair by providing a three-dimensional extracellular matrix for cellular attachment and proliferation while ...

6. trialx.com trialx.com/clinical-trials/listings/321648/connective-tissue-matrix-compared-to-steroid-injections-for-rotator-cuff-tendinopathy/

Connective Tissue Matrix Compared to Steroid Injections ... The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix boost ...

7. trials.arthritis.org trials.arthritis.org/trials/NCT06160427

Connective Tissue Matrix for Rotator Cuff Tendinopathy The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05894265

NCT05894265 | Prospective Study to Determine the Safety ... The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair ...

9. app.trialscreen.org app.trialscreen.org/trials/phase-4-connective-tissue-matrix-ctm-rotator-cuff-tendinopathy-trial-nct06160427

Connective Tissue Matrix for Rotator Cuff Tendinopathy This study aims to determine if a single injection of CTM Boost, a placenta-derived connective tissue matrix, is as effective as a single injection of platelet ...