Trial · NCT07898514
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 | Change From Baseline in Sitting-Related Coccygeal Pain on the Numeric Rating Scale at 3 Months After Treatment Completion | Baseline (before the first treatment session) and 3 months after the final treatment session | Sitting-related coccygeal pain is assessed using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10, with higher scores indicating more severe pain. Change is calculated as the score 3 months after the final treatment session minus the pretreatment baseline score. Negative change scores indicate pain reduction. The primary comparison is the difference in mean change between the extracorporeal shock wave therapy and high-intensity laser therapy groups. |
| Secondary | Change From Baseline in Sitting-Related Coccygeal Pain on the Numeric Rating Scale at 1 Month After Treatment Completion | Baseline (before the first treatment session) and 1 month after the final treatment session | Sitting-related coccygeal pain is assessed using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10, with higher scores indicating more severe pain. Change is calculated as the score 1 month after the final treatment session minus the pretreatment baseline score. Negative change scores indicate pain reduction. |
| Secondary | Change From Baseline in Overall Coccygeal Pain on the Numeric Rating Scale | Baseline (before the first treatment session), and 1 and 3 months after the final treatment session | Overall coccygeal pain is assessed separately from sitting-related pain using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10. Higher scores indicate more severe pain. Change is calculated separately at each follow-up as the follow-up score minus the pretreatment baseline score. Negative change scores indicate pain reduction. |
| Secondary | Change From Baseline in Oswestry Disability Index Percentage Score | Baseline (before the first treatment session), and 1 and 3 months after the final treatment session | The Oswestry Disability Index (ODI) assesses pain-related disability across 10 sections, each scored from 0 to 5. The percentage score is calculated as the sum of section scores divided by five times the number of answered sections, multiplied by 100. Scores range from 0 to 100%, with higher scores indicating greater disability. Change is calculated separately at each follow-up as the follow-up percentage score minus the baseline percentage score. Changes are expressed in percentage points, with negative values indicating reduced disability. |
| Secondary | Change From Baseline in Paris Functional Coccydynia Impact Questionnaire Score | Baseline (before the first treatment session), and 1 and 3 months after the final treatment session | The Paris Functional Coccydynia Impact Questionnaire (PFCIQ) assesses the impact of coccydynia during sitting, rising from sitting, standing or walking, traveling, and nighttime. In the five-item study form, item scores are summed and multiplied by 10 to obtain a total score from 0 to 100. Higher scores indicate greater symptom impact. Change is calculated separately at each follow-up as the follow-up score minus the baseline score. Negative changes indicate improvement. |
| Secondary | Patient Global Impression of Change Score | 1 and 3 months after the final treatment session | The Patient Global Impression of Change (PGIC) is a single-item assessment of the participant's overall change in condition since treatment began. The study form uses seven response categories scored from -3 (very much worse) to +3 (very much improved), with 0 indicating no change. Higher scores indicate greater perceived improvement. The score is assessed at each follow-up; no pretreatment PGIC score is subtracted. |
| Secondary | Treatment Satisfaction on a Five-Point Likert Scale | 1 and 3 months after the final treatment session | Participants rate their satisfaction with the assigned treatment using a five-point Likert scale: 1, not at all satisfied; 2, not satisfied; 3, undecided; 4, satisfied; and 5, very satisfied. Higher scores indicate greater treatment satisfaction. Satisfaction is assessed separately at each follow-up visit. |
| Secondary | Change From Baseline in Unsupported Sitting Duration | Baseline (before the first treatment session), and 1 and 3 months after the final treatment session | Unsupported sitting duration is recorded in minutes. Change is calculated separately at each follow-up as the recorded follow-up duration minus the pretreatment baseline duration. Positive changes indicate an increase in sitting duration. |
| Secondary | Percentage of Participants Able to Sit for 30 Minutes | Baseline (before the first treatment session), and 1 and 3 months after the final treatment session | The ability to sit for 30 minutes is recorded as yes or no at each assessment. The outcome is the percentage of participants with a yes response at each time point. |
| Secondary | Percentage of Participants Using Analgesics | Baseline (before the first treatment session), and 1 and 3 months after the final treatment session | Analgesic use for coccygeal pain is recorded as yes or no at baseline and follow-up assessments. The outcome is the percentage of participants with analgesic use recorded as yes at each assessment. This is a binary measure, not a measure of dose or tablet count. |
| Secondary | Percentage of Participants Requiring Additional Treatment | 1 and 3 months after the final treatment session | The need for additional treatment for coccydynia is recorded as yes or no at each follow-up assessment. The outcome is the percentage of participants with a documented need for additional treatment at each follow-up. This measure concerns treatment need rather than confirmation that an additional treatment was received. |
| Secondary | Percentage of Participants With Adverse Events or Complications | From the first treatment session through 3 months after the final treatment session | The outcome is the percentage of participants with at least one adverse event or complication recorded during the observation period. The case report form records the presence or absence of an adverse event or complication. Each affected participant is counted once for this outcome, regardless of the number of events. |
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.
For software
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