NCT06373978 · The Cleveland Clinic
NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow
What this study is about
This study is a where neither patients nor doctors know which treatment is given, randomly assigned controlled trial comparing the effectiveness of taken by mouth 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.
View original scientific description
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.
Interventions
DRUG
Diclofenac
50mg every 8hours as needed for pain
DRUG
Tramadol
50mg every 8hours as needed for pain
OTHER
Acetaminophen
1000mg every 8hours as needed for pain
Primary outcome measures
Number of pills taken
Time frame: 10 days
The number of total Tramadol pills taken per patient between the control (Tramadol + Diclofenac rescue) vs experimental (Diclofenac + Tramadol rescue) groups at two weeks.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-65 years
- Percutaneous Needle Tenotomy of Lateral Elbow Procedure
- Ability to take oral medication and willingness to participate in a 2-week follow-up pill counts
- Musculoskeletal ultrasound or MRI with diagnosis of tendinosis of the common extensor tendon of the elbow
Exclusion criteria
- • Any full thickness common extensor tendon tear of the elbow
- Prior history of elbow surgery
- Symptomatic cervical radiculopathy
- Concurrent symptoms of the medial elbow
- Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control
- Psychiatric illness that impedes evaluation of pain and/or narcotics use
- No history of inflammatory arthritis, diabetes, chronic regional pain syndrome, conne
Where
- Coral Springs, Florida
- Avon, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations