Trial · NCT07887607
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in health-related quality of life assessed by KDQOL-36 domain scores | Baseline, week 6, week 12, and week 24 | Health-related quality of life will be assessed using the Kidney Disease Quality of Life 36-item questionnaire (KDQOL-36). The instrument includes the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS), as well as three kidney disease-specific domains: Symptoms and Problems, Effects of Kidney Disease, and Burden of Kidney Disease. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. The KDQOL-36 will be administered at baseline, at week 6, at the end of the 12-week intervention, and at the 12-week post-intervention follow-up (24 weeks). Changes over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in handgrip strength | Baseline, week 6, week 12, and week 24 | Handgrip strength will be measured as an objective assessment of functional capacity. Changes over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in individual symptom scores assessed by the ESAS-r | Baseline, week 6, week 12, and week 24 | Symptom burden will be assessed using the revised Edmonton Symptom Assessment System (ESAS-r). The intensity of each symptom will be rated separately on a numerical scale from 0 to 10, with higher scores indicating greater symptom intensity. Changes in individual symptom scores over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) global score | Baseline, week 6, week 12, and week 24 | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The validated Greek version will be used. Changes in global scores over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in Brief Pain Inventory (BPI) pain interference score | Baseline, week 6, week 12, and week 24 | The impact of pain on daily functioning will be assessed using the pain interference subscale of the Brief Pain Inventory (BPI). The pain interference score ranges from 0 to 10, with higher scores indicating greater interference of pain with daily activities. Changes over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in pressure pain threshold assessed by algometry | Baseline, week 6, week 12, and week 24 | Pressure pain threshold will be measured using an algometer as an exploratory assessment of mechanical pain sensitivity. Higher pressure pain threshold values indicate lower mechanical pain sensitivity. Changes over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in 5-D Itch Scale total score | Baseline, week 6, week 12, and week 24 | Pruritus will be assessed using the 5-D Itch Scale, which evaluates five dimensions: duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating greater pruritus burden. The validated Greek version will be used. Changes over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in circulating beta-endorphin concentration | Baseline, week 6, week 12, and week 24 | Circulating beta-endorphin levels will be measured in peripheral blood samples collected at four predefined time points: baseline (T0), week 6 (T1), week 12 (T2), and week 24 (T3). Changes over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in circulating Substance P concentration | Baseline, week 6, week 12, and week 24 | Circulating Substance P concentration will be measured in peripheral blood samples collected at four predefined time points: baseline (T0), week 6 (T1), week 12 (T2), and week 24 (T3). Changes over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in circulating calcitonin gene-related peptide (CGRP) concentration | Baseline, week 6, week 12, and week 24 | Circulating calcitonin gene-related peptide (CGRP) concentration will be measured in peripheral blood samples collected at four predefined time points: baseline (T0), week 6 (T1), week 12 (T2), and week 24 (T3). Changes over time will be compared between the acupuncture and sham acupuncture groups. |
| Secondary | Change in serum proteomic/peptidomic profile | Baseline and end of intervention (up to 12 weeks) | Exploratory serum proteomic/peptidomic analyses will be performed before and after the treatment cycle to investigate changes in the serum proteomic/peptidomic profile following the intervention. |
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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