Trial · NCT06863662
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of the percentage change in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 of follow-up relative to baseline, within each treatment group. | 7 days | The Visual Analog Scale (VAS) for pain is a straight line anchored by two descriptors: one end indicating no pain and the other representing the worst pain imaginable. The investigator will administer the VAS at each study visit to assess pain intensity. At the end of the clinical trial, the percentage change in pain scores from baseline will be calculated and compared between treatment groups. |
| Primary | Number of participants reporting treatment-related adverse events, as documented in the patient diary. | 7 days | To describe the frequency, intensity, and causality of adverse events reported during the clinical trial, stratified by treatment group. Adverse events will be recorded by patients in their diary logs. Each event will be monitored and followed up at the discretion of the investigator. |
| Secondary | Analyze the percentage change in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7, compared to baseline, within and between each treatment group. | 7 days | The Visual Analog Scale (VAS) for pain is a straight line anchored by two descriptors: one end represents the absence of pain, and the other indicates the worst pain imaginable. The investigator will administer the VAS at each study visit to assess pain intensity. At the end of the clinical trial, the percentage change in pain scores from baseline will be calculated and compared across treatment groups. Patients will attend in-person visits on Days 0, 3, and 7 of follow-up, and the investigator will conduct follow-up phone calls on Days 1 and 5. |
| Secondary | Compare the proportion of patients in each treatment group who achieve a ≥30% reduction in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 relative to baseline. | 7 days | The Visual Analog Scale (VAS) for pain is a unidimensional tool consisting of a straight line anchored by two descriptors: one end indicating "no pain" and the other representing "the worst pain imaginable." The investigator will administer the VAS at each study visit to assess pain intensity. The proportion of patients achieving a reduction in pain of more than 30% from baseline will be recorded and compared across treatment groups on Days 1, 3, 5, and 7. |
| Secondary | Compare the proportion of patients in each treatment group who achieve a ≥50% reduction in pain intensity, as measured by the Visual Analog Scale (VAS), on Days 1, 3, 5, and 7 relative to baseline. | 7 days | The Visual Analog Scale (VAS) for pain is a straight line anchored by two descriptors: one end represents the absence of pain, and the other indicates the worst pain imaginable. The investigator will administer the VAS at each study visit to evaluate pain intensity. The proportion of patients achieving a pain reduction greater than 30% from baseline will be documented and compared across treatment groups on Days 1, 3, 5, and 7. |
| Secondary | Determine the follow-up time point at which each treatment group demonstrates the greatest reduction in pain intensity, as measured by the Visual Analog Scale (VAS). | 7 days | The Visual Analog Scale (VAS) for pain is a unidimensional measurement tool represented by a straight line anchored by two descriptors: one end indicating "no pain" and the other representing "the worst pain imaginable." The investigator will administer the VAS at each study visit to assess the patient's pain intensity. |
| Secondary | Compare the proportion of patients in each treatment group according to the severity of lumbar muscle spasm, as assessed by the Investigator's Global Subjective Assessment. | 7 days | The investigator will assess the severity of lumbar muscle spasm using a global subjective scale, which will also allow evaluation of the muscle's response to movement following administration of the study treatment. |
| Secondary | Assess and compare the degree of physical disability caused by acute low back pain, as measured by the Oswestry Disability Questionnaire, on Days 3 and 7 in each treatment group, relative to baseline. | 7 days | The Oswestry Disability Questionnaire is designed to assess how back pain affects a patient's ability to perform daily activities. It categorizes quality of life into five levels: no disability, mild disability, moderate disability, severe disability, and complete disability. The degree of disability will be assessed and compared between treatment groups. |
| Secondary | Assess and compare the degree of disability in performing daily activities due to low back pain, as reported using the Roland-Morris Disability Questionnaire, on Days 3 and 7 in each treatment group, relative to baseline. | 7 days | The Roland-Morris Disability Questionnaire is designed to assess functional mobility and limitations in daily activities due to low back pain. It consists of 24 items, with higher scores indicating a greater degree of disability. A maximum score of 24 reflects the most severe disability. The degree of disability will be assessed and compared between treatment groups. |
| Other | Report the percentage of therapeutic adherence on Day 7 of the intervention, in each treatment group. | 7 days | Therapeutic adherence will be defined by the principal investigator. Adherence will be considered adequate when the patient has taken ≥80% of the prescribed doses by the time of the corresponding evaluation. |
| Other | Report the number of patients in each treatment group who require the use of rescue medication during the clinical trial. | 7 days | The designated rescue medication will be acetaminophen 500 mg. If a patient feels the need for rescue medication, they must contact the study physician. The physician will assess the patient's pain using the Visual Analog Scale (VAS) via telephone. If deemed appropriate, the physician will authorize the use of the rescue medication. |
| Other | Report the number of patients who experience therapeutic failure during the study, stratified by treatment group. | 7 days | Therapeutic failure will be defined by the principal investigator following a medical consultation. The following criteria must be met: a decrease of less than 10 mm or an increase in pain intensity on the Visual Analog Scale (VAS) compared to baseline, along with a treatment adherence rate of ≥80%. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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