An interventional study of Experimental(Acelex cap m2mg) and Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics) in Rotator Cuff Tear, sponsored by Eulji University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Eulji University Hospital · Not applicable, Interventional, and Treatment
**⑧-1. Visit 0: Pre-surgery Admission, Orthopedic Ward (Consent Acquisition and Screening)** According to the investigator\'s judgment, patients who are considered potential candidates will be encouraged to participate in the clinical trial. One day (±1 day) before surgery, the investigator or designated study staff will thoroughly explain the clinical trial process to the participant and their guardian (representative) based on the informed consent form and provide the form so that all participants and their guardians have sufficient time to read, discuss, and decide. Participants who agree to participate in the clinical trial will voluntarily sign the written consent form and receive a copy of the signed consent form before any study-related procedures are conducted. The clinical trial site will assign a screening number to patients who voluntarily provide consent and undergo screening. The screening number can be assigned in the order in which the participants sign the consent within the study site. After confirming eligibility based on inclusion/exclusion criteria, randomization will be performed to assign participants to either the treatment group or the control group (with a 1:1 ratio). If assigned to the treatment group, participants will receive 'Polmacoxib (preventive Acelex cap 2mg) once daily,' and NSAIDs-excluded non-opioid/opioid analgesics - PRN. If assigned to the control group, participants will receive NSAIDs-excluded non-opioid or opioid analgesics. Data will be collected by comparing the two groups in a double-arm setup. Pain scores, UCLA/ASES scores, and joint range of motion will be collected, and this data will be valid up to 3 months before the surgery.
**Visit 0 Investigations and Examinations:**
Randomization
**Visit 1 Investigations and Examinations:**
Medication administration
**Visit 2 Investigations and Examinations:**
Cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (post-surgery)
**Visit 3 Investigations and Examinations:**
Cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (cumulative since surgery)
**Visit 4 Investigations and Examinations:**
Check for adverse events
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Eulji University Hospital is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental Arm (Polmacoxib (Acelex cap 2mg) + Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB)) 1. Polmacoxib (preventive Acelex cap 2mg) administration, Method: One tablet orally once daily, regardless of meals.
Drug: Experimental(Acelex cap m2mg)
Control Group (Administration of Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB)) 1. Non-NSAID Non-Opioid or Opioid Analgesics(ULTRACET ER SEMI TAB), Administration Method: PRN
Drug: Active Comparator(NSAIDs-excluded non-opioid or opioid analgesics)
Experimental Arm (Polmacoxib (Acelex cap 2mg + NSAIDs-excluded non-opioid or opioid analgesics)) Polmacoxib (preventive Acelex cap 2mg) administered, dosage: 1 tablet orally once daily, regardless of meals. NSAIDs-excluded non-opioid or opioid analgesics, dosage: as needed (PRN).
NSAIDs-excluded non-opioid or opioid analgesics, dosage: as needed (PRN).
Primary Outcome Measure-Cumulative administration frequency of narcotic analgesics (e.g., Fentanyl injection), excluding NSAIDs
Postoperative pain in subjects is managed during the hospital stay by administering non-narcotic or narcotic analgesics, excluding NSAIDs (e.g., Fentanyl injection). Pain levels are assessed by collecting data on the frequency of administration.
Time frame: At postoperative day 3
Secondary Outcome Measure-Cumulative number of doses of non-opioid analgesics excluding NSAIDs
- Cumulative number of doses of non-opioid analgesics excluding NSAIDs (e.g., Ultracet)
Time frame: - 3 days post-surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery
Secondary Outcome Measure-Range of Motion (ROM)
Range of Motion (ROM)
Time frame: 1 day before surgery, 12 weeks post-surgery
Secondary Outcome Measure-Rotator cuff re-tear status
Rotator cuff re-tear status
Time frame: 12 weeks post-surgery
Secondary Outcome Measure
* VAS pain scale * The VAS pain scale can be expressed using 11 levels, represented by numbers from 0 to 10. In this case, the patient selects a number that corresponds to the intensity of the pain they are experiencing, ranging from 0 (no pain) to 10 (the worst imaginable pain). The meaning of each number is as follows: 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-9: Severe pain 10: Worst possible pain
Time frame: - 1 day before surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery
Primary Outcome Measure-ASES score
* ASES Score * The ASES Score (American Shoulder and Elbow Surgeons Score) is a standardized tool used to assess shoulder function and pain. It provides an objective measurement of shoulder conditions and treatment outcomes by evaluating both subjective pain and functional status. The ASES score consists of two key components: Pain Assessment: Patients rate their pain intensity on a numeric scale from 0 to 10, where 0 means no pain and 10 indicates severe pain. Functional Assessment: It includes 10 questions that evaluate daily shoulder and arm function. Each question is scored from 0 to 3, and this component plays a crucial role in assessing the patient\'s ability to perform daily activities. The final ASES score is calculated on a scale of 0 to 100, with higher scores indicating better shoulder function and less pain. This score helps healthcare professionals monitor shoulder conditions and evaluate treatment effectiveness.
Time frame: 1 day before surgery, 12 weeks post-surgery
Secondary Outcome Measure-UCLA score
* UCLA Score * The UCLA Shoulder Rating Scale is a standardized tool used to assess shoulder function and pain. It is commonly utilized to evaluate postoperative outcomes or to diagnose shoulder-related conditions. The UCLA score is based on five components, totaling a maximum of 35 points: Pain (10 points): Evaluates the intensity of the patient\'s pain. Function (10 points): Assesses the patient\'s ability to use the shoulder in daily activities. Range of Motion (5 points): Measures the range of motion in the shoulder. Strength (5 points): Assesses the strength of the shoulder and arm. Patient Satisfaction (5 points): Evaluates how satisfied the patient is with their shoulder condition. Score Interpretation: 34-35 points: Excellent 28-33 points: Good 21-27 points: Fair 20 points or below: Poor The UCLA score provides a comprehensive assessment of shoulder pain and function, making it particularly useful for tracking recovery after procedures like arthroscopic shoul
Time frame: 1 day before surgery, 12 weeks post-surgery
Plan to share: Undecided
Started Aug 2024 (actual). Primary completion is estimated for Aug 2025, 11 months after the start.
Of 228 non-industry interventional studies with no phase under Rotator Cuff Injuries, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 11 months is below that.
Counting every sponsor, half of 252 studies reached it within 23 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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Eulji University Hospital