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

Trial Summary

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 data supports the effectiveness of the drug Diclofenac (Voltaren) 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, which suggests it may also help with elbow pain. It has been shown to provide significant pain relief and is generally well tolerated with fewer side effects compared to similar drugs. ^{1 2 3 4 5}

Is diclofenac generally safe for humans?

Diclofenac, found in products like Voltaren, has been shown to be generally well tolerated in humans, with some reports of mild side effects mainly related to the stomach and digestive system. Compared to other similar medications, it tends to cause fewer unwanted effects. ^{2 4 6 7 8}

How does the drug Diclofenac differ from other treatments for elbow pain?

Diclofenac is unique because it not only reduces inflammation by inhibiting COX-2 enzymes but also has a special ability to cross the blood-brain barrier, which may enhance its effectiveness in reducing chronic neuro-inflammatory pain. ^{1 2 9 10 11}

What is the purpose of this trial?

This study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.

Research Team

Michael Dakkak, DO

Principal Investigator

Cleveland Clinic Florida

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

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 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 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]

References

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

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

2. Norway pubmed.ncbi.nlm.nih.gov

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

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

Biliary colic treatment and acute cholecystitis prevention by prostaglandin inhibitor. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Long-term comparative study: diclofenac (voltaren) and naproxen (proxen) in arthritis]. [2013]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

Diclophenax sodium (Voltaren) in rheumatoid arthritis: a double-blind comparison with indomethacin and placebo. [2013]

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

Pharmacology of diclofenac sodium. [2019]

8. England 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. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

Spinal antinflammatory action of Diclofenac. [2017]

10. Germany pubmed.ncbi.nlm.nih.gov

[Non-opioid analgesics and co-analgesics in therapy of chronic pain]. [2008]

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

Comparison of diflunisal and naproxen in the treatment of tennis elbow. [2013]