Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si, Gyeonggi-do, 11759, South Korea
Location status: Recruiting
Location contact
JAEMAN KWAK
CONTACT
JAEMAN KWAK
PRINCIPAL_INVESTIGATOR
SUIN JEONG
CONTACT
NCT Number: NCT06590714
1. **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 'Polacoxib (preventive Acelex cap 2mg) once daily, NSAIDs-excluded non-opioid/opioid analgesics - PRN use.' 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. (For patients taking NSAIDs or Ultracet, the dose will be maintained until v5.) 2. **Two hours before surgery:** Administration of medication begins. 3. **Three days after surgery:** Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (post-surgery). Non-opioid or opioid analgesics (e.g., Fentanyl injection or Ultracet) will be used to manage post-surgical pain, and the number of doses will be collected to assess the participant's pain. 4. **Two weeks after surgery:** An outpatient visit will be conducted one week after discharge. Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses at the two-week mark. 5. **Six weeks after surgery:** Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses. 6. **Three months after surgery:** MRI will be performed to check for re-tears (optional for participants). This visit will be the study's completion visit, during which pain scores, UCLA/ASES scores, joint range of motion, and cumulative doses of NSAIDs-excluded non-opioid or opioid analgesics will be collected. If adverse events occurring during the treatment period have resolved before this completion visit, no additional safety follow-up will be performed, and this visit will be considered the end of the clinical trial. If adverse events have not resolved by the completion visit, follow-up will continue until the adverse events have either returned to pre-study or baseline levels, or the principal investigator or designee determines that the adverse events have stabilized, or no further follow-up is deemed necessary. This follow-up will mark the completion of the clinical trial.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Uijeongbu-si, Gyeonggi-do, 11759, South Korea
Location status: Recruiting
JAEMAN KWAK
CONTACT
JAEMAN KWAK
PRINCIPAL_INVESTIGATOR
SUIN JEONG
CONTACT
**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:**
**Visit 1 Investigations and Examinations:**
**Visit 2 Investigations and Examinations:**
**Visit 3 Investigations and Examinations:**
**Visit 4 Investigations and Examinations:**
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: At postoperative day 3
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: - 3 days post-surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery
Time frame: 1 day before surgery, 12 weeks post-surgery
Range of Motion (ROM)
Time frame: 12 weeks post-surgery
Rotator cuff re-tear status
Time frame: - 1 day before surgery - 2 weeks post-surgery - 6 weeks post-surgery - 12 weeks post-surgery
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, 12 weeks post-surgery
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
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
Contact information is provided by the study sponsor or research team.
JAEMAN KWAK
CONTACT
SUIN JEONG
CONTACT
Eulji University Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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