NonNarcotic Pain Control for Elbow Pain

Recruiting at 1 trial location

Overseen By Jason Genin, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

Disqualifiers: Elbow surgery, Radiculopathy, Arthritis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10 days

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to manage elbow pain without narcotics by comparing three medicines: acetaminophen, diclofenac (a nonsteroidal anti-inflammatory drug), and tramadol. The goal is to determine which medicine best reduces the need for narcotics after a specific elbow procedure. Individuals who have undergone a needle procedure on the outer elbow and have a diagnosis of tendinosis (a type of tendon injury) may be suitable for this study. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, aiming to understand how they benefit more patients.

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 are on another investigational drug or treatment that affects pain control, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that diclofenac is generally safe, even for individuals with other health issues. However, specific information about its effectiveness for elbow pain remains limited, making it difficult to determine the risks and benefits for this condition.

Tramadol, approved by the FDA for treating moderate-to-severe pain, is considered safe and effective for muscle and nerve pain. However, over time, higher doses may be needed for the same relief, and it can be habit-forming.

In summary, both diclofenac and tramadol are generally well-tolerated, but each requires careful consideration of its specific factors. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for elbow pain because they offer non-narcotic alternatives for pain management. Diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), works by reducing substances in the body that cause inflammation and pain, differing from opioid-based treatments like tramadol that carry a risk of dependency. Additionally, the trial includes acetaminophen as a sham comparator, which is commonly used but does not address inflammation. Diclofenac and tramadol present options that might effectively control pain without the side effects associated with traditional opioids or the limitations of acetaminophen.

What evidence suggests that this trial's treatments could be effective for elbow pain?

In this trial, participants will receive either diclofenac or tramadol to manage elbow pain. Research has shown that diclofenac (also known as Voltaren) effectively reduces pain and improves joint movement in conditions like rheumatoid arthritis and osteoarthritis, and it also provides short-term relief for elbow pain. Meanwhile, studies suggest that tramadol offers more pain relief than some other treatments, though it may cause more side effects. Tramadol changes how the brain perceives pain. Both diclofenac and tramadol can help manage pain, potentially reducing the need for stronger painkillers. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Dakkak, DO

Principal Investigator

Cleveland Clinic Florida

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic elbow pain who are undergoing a specific minimally invasive procedure called percutaneous needle tenotomy. Participants should not have used narcotic pills before the surgery and must be willing to take either Diclofenac or Tramadol as part of the study.

Inclusion Criteria

I am willing and able to follow the study rules and attend all required visits.

I am having a procedure for tennis elbow using needles.

I can take pills and agree to follow-up on my medication use.

Exclusion Criteria

I can safely take NSAIDs and opioids.

I have a complete tear in the tendon near my elbow.

I have had elbow surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral acetaminophen, diclofenac, and tramadol following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow

10 days

1 visit (in-person) at 10 days (± 4 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with pill counts and use of rescue narcotics verified

10 days

1 visit (in-person) at 10 days (± 4 days)

What Are the Treatments Tested in This Trial?

Interventions

• Diclofenac
• Tramadol

Trial Overview The study tests whether Diclofenac, a non-narcotic pain reliever, can reduce the need for narcotics after elbow surgery compared to Tramadol, which has narcotic-like effects. Patients will be randomly assigned to one of these medications in a blinded manner.

How Is the Trial Designed?

Group I: Tramadol Active Control 2 Interventions

50mg

Group II: Diclofenac Active Control 2 Interventions

50mg

Group III: Acetaminophen Placebo Group 1 Intervention

1000mg

Diclofenac is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Voltaren for:

• Ankylosing Spondylitis
• Aseptic Necrosis
• Back Pain
• Chronic Pain
• Frozen Shoulder
• Headache
• Migraine
• Muscle Pain
• Osteoarthritis
• Pain
• Period Pain
• Rheumatoid Arthritis
• Sciatica
• Spondyloarthritis

Approved in European Union as Voltaren for:

• Osteoarthritis
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Migraine
• Pain
• Dysmenorrhea

Approved in Canada as Voltaren for:

• Osteoarthritis
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Migraine
• Pain
• Dysmenorrhea

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study involving 38 patients with mild-to-moderate tennis elbow, both diflunisal and naproxen were effective in reducing pain and swelling, showing no significant differences in physician assessments.

However, patients reported significantly greater pain relief with diflunisal compared to naproxen, suggesting it may be the preferred NSAID for managing tennis elbow symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of diflunisal and naproxen in the treatment of tennis elbow. Stull, PA., Jokl, P.[2013]

In a double-blind trial involving hospitalized patients with rheumatoid arthritis, both diclofenac sodium (50 mg b.i.d.) and naproxen (250 mg b.i.d.) effectively reduced morning stiffness, improved grip strength, and alleviated pain, showing no significant difference in clinical efficacy between the two.

Diclofenac sodium was associated with fewer unwanted side effects compared to naproxen, with only three patients on diclofenac reporting adverse effects versus seven on naproxen, suggesting it may be a better-tolerated option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diclofenac sodium (Voltaren) and naproxen in the treatment of rheumatoid arthritis: a comparative double-blind study. Kajander, A., Martio, J.[2019]

In rheumatoid arthritis, ibuprofen is the most effective non-opioid analgesic with the best balance of effectiveness and side effects, while alternatives like naproxen, diclofenac, and meloxicam are also viable options.

For chronic pain management, it is recommended to use lower doses of non-opioid analgesics to minimize side effects, as shown by the discontinuation rates: ibuprofen (3.8%) had the lowest, while diclofenac (17.8%) had the highest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-opioid analgesics and co-analgesics in therapy of chronic pain]. Gehling, M., Niebergall, H.[2008]

In a study involving 40 male patients with cox-arthrosis or gonarthrosis, both diclofenac and naproxen showed significant analgesic effects and improved joint mobility over a treatment period of up to six months.

Diclofenac appeared to provide a more pronounced pain relief compared to naproxen, although both medications were well tolerated with only occasional gastrointestinal side effects, particularly in the naproxen group, and no evidence of serious organ toxicity was found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term comparative study: diclofenac (voltaren) and naproxen (proxen) in arthritis]. Siegmeth, W., Placheta, P.[2013]

In a study involving 2177 patients with various chronic pain conditions, two compounded topical creams (Cream I and Cream II) significantly reduced pain intensity scores by 37% and 35%, respectively, compared to a 19% reduction with Voltaren gel.

Both Cream I and Cream II were found to be more effective than Voltaren gel, suggesting that compounded topical formulations may offer better pain relief options for patients with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Evaluation on the Analgesic Activities of 2 Compounded Topical Creams and Voltaren Gel in Chronic Noncancer Pain. Somberg, JC., Molnar, J.[2022]

In a four-week double-blind trial involving 182 patients with rheumatoid arthritis, diclofenac sodium (Voltaren) showed comparable effectiveness to indomethacin in improving clinical symptoms, while the placebo group showed no significant changes.

Voltaren was associated with fewer central nervous system side effects compared to indomethacin, although both medications had similar gastrointestinal side effects, indicating a potentially safer profile for Voltaren.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diclophenax sodium (Voltaren) in rheumatoid arthritis: a double-blind comparison with indomethacin and placebo. Kirchheiner, B., Trang, L., Wollheim, FA.[2013]

In a trial involving 30 patients with osteo-arthrosis, diclofenac (Voltaren) provided greater relief from pain and stiffness compared to naproxen over a two-week period.

Voltaren was better tolerated than naproxen, with fewer patients reporting side effects and those who did experienced less severe complaints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diclofenac (Voltaren) for the treatment of osteo-arthrosis: a double-blind comparison with naproxen. Siraux, P.[2017]

Diclofenac sodium, the active ingredient in Voltaren, has been shown to effectively reduce inflammation and pain in animal models, demonstrating its analgesic and anti-inflammatory properties.

The compound has a favorable safety profile compared to other nonsteroidal anti-inflammatory drugs, as indicated by its tolerability metrics, and it works by inhibiting cyclo-oxygenase and lipoxygenase pathways, which are crucial in the inflammatory response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology of diclofenac sodium. Scholer, DW., Ku, EC., Boettcher, I., et al.[2019]

In a study of 467 adults using over-the-counter Voltaren gel (diclofenac), participants reported a significant reduction in pain severity, improving by an average of 1.2 points on a scale of 0 to 10 after 12 weeks of treatment.

The majority of users, particularly those aged 65 and older, showed high satisfaction with the treatment and rarely switched to other topical therapies, indicating that Voltaren gel is a well-tolerated option for managing musculoskeletal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experience and utilization patterns of diclofenac gel in Germany: a real-world study with a prospective longitudinal survey and a retrospective analysis of pharmacy data. Maihöfner, C., de Haas, A., Sethi, V., et al.[2023]

Diclofenac is an effective NSAID for treating chronic pain associated with inflammatory conditions like rheumatoid arthritis and osteoarthritis, due to its unique mechanisms of action.

It works by activating PPAR-γ, inhibiting COX-2 to reduce prostaglandin synthesis, blocking neuronal K+ channels to suppress hyperexcitability, and can cross the blood-brain barrier, enhancing its pain-relieving effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal antinflammatory action of Diclofenac. Sandri, A.[2017]

In a study of 60 patients with biliary colic, those treated with diclofenac sodium (Voltaren) experienced significantly better pain relief compared to those treated with placebo or papaverine, with a p-value of less than 0.002.

None of the patients treated with Voltaren required hospitalization or surgery, while nine patients from the placebo and papaverine groups progressed to acute cholecystitis, highlighting Voltaren's potential effectiveness in managing biliary colic and preventing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biliary colic treatment and acute cholecystitis prevention by prostaglandin inhibitor. Goldman, G., Kahn, PJ., Alon, R., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7173751/

Non‐steroidal anti‐inflammatory drugs (NSAIDs) for treating ... In our previous review, we concluded that there was some support for the use of topical NSAIDs to relieve lateral elbow pain in the short term but insufficient ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085454/

Evaluating the Real-World Use of Topical Diclofenac Sodium ... The study results indicate that DSG demonstrated a favorable safety profile, particularly for patients with comorbidities and high-risk factors and when used ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/03007995.2023.2243804

a real-world study with a prospective longitudinal survey ... This study provides the first real-world insights into OTC VGD use in Germany. The participants using VGD reported a decrease in pain severity and an ...

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-05328-3

a randomized controlled trial | BMC Musculoskeletal Disorders Intra-articularly administered DF-HA for hip OA produced a rapid response and was safe, with analgesia maintained for 12 weeks when administered every 4 weeks.

5. withpower.com withpower.com/trial/phase-4-pain-elbow-5-2024-45aa0

NonNarcotic Pain Control for Elbow Pain Research shows that Diclofenac (Voltaren) is effective in reducing pain and improving joint movement in conditions like rheumatoid arthritis and osteo-arthrosis ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/diclofenac-topical-application-route/description/drg-20063434

Diclofenac (topical application route) - Side effects & dosage Diclofenac is used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain.

7. mayoclinic.org mayoclinic.org/symptoms/elbow-pain/basics/when-to-see-doctor/sym-20050874

Elbow pain When to see a doctor Most elbow pain improves with care at home using PRICE treatment. Try pain relievers you can buy without a prescription.