An interventional study of Acupuncture and Optimized conventional pharmacological treatment in Chronic Pain, Neuralgia and Renal Insufficiency,Chronic, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
This study evaluated acupuncture plus optimized conventional pharmacological treatment compared with optimized conventional pharmacological treatment alone for chronic pain in adults with chronic kidney disease receiving conservative treatment, peritoneal dialysis, or hemodialysis. The study was conducted prospectively at a single center. Actual allocation was not exclusively randomized because some participants who expressed a preference for acupuncture before allocation were assigned to the acupuncture group, while the planned random sequence was used for participants without an expressed preference.
The purpose of this study was to evaluate the efficacy of acupuncture combined with optimized conventional pharmacological treatment compared with optimized conventional pharmacological treatment alone for chronic pain in adults with chronic kidney disease receiving conservative treatment or renal replacement therapy.
The study was conducted prospectively at a single center. The intervention group received individualized acupuncture in addition to optimized conventional pharmacological treatment. Acupuncture was administered weekly for approximately four months, with 16 sessions planned and a minimum of 10 sessions considered necessary for efficacy evaluation. The comparison group received optimized conventional pharmacological treatment alone, with monthly follow-up over approximately four months.
The original protocol planned simple 1:1 randomization using a computer-generated sequence. During recruitment, some eligible participants expressed a preference for acupuncture before allocation and refused the possibility of receiving conventional pharmacological treatment alone. These participants were allocated to the acupuncture group regardless of the planned random sequence. Participants without an expressed preference were allocated using the planned sequence. Therefore, actual allocation was not exclusively randomized.
The original protocol included patients receiving conservative treatment or peritoneal dialysis. An amendment approved on September 25, 2025, added patients receiving hemodialysis. The first hemodialysis participant was enrolled on September 29, 2025, after approval of the amendment.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 110 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
Individualized acupuncture administered weekly for approximately four months, with 16 sessions planned and a minimum of 10 sessions considered necessary for efficacy evaluation. Participants also received optimized conventional pharmacological treatment.
Other: Acupuncture · Drug: Optimized conventional pharmacological treatment
Optimized conventional pharmacological treatment for chronic pain, without acupuncture.
Drug: Optimized conventional pharmacological treatment
Individualized acupuncture administered weekly for approximately four months, with 16 sessions planned and a minimum of 10 sessions considered necessary for efficacy evaluation.
Conventional pharmacological treatment for chronic pain in patients with chronic kidney disease, individualized according to the treating physician's clinical judgment.
Change in pain intensity from baseline to the final study visit
Change in pain intensity from baseline to 5 months, measured using the 0-to-10 Visual Analog Scale (VAS) for pain, where 0 indicates no pain and 10 the worst imaginable pain. Higher scores indicate worse pain; a negative change indicates improvement.
Time frame: Baseline and 5 months
Proportion of participants achieving a reduction of at least 2 points in pain intensity
Proportion of participants with a reduction of at least 2 points in pain intensity on the 0-to-10 Visual Analog Scale (VAS) for pain, where 0 indicates no pain and 10 the worst imaginable pain, from baseline to 5 months.
Time frame: Baseline and 5 months
Change in limitation of daily activities
Change from baseline to the final study visit in pain-related limitation of daily activities, assessed with the Daily Activity Assessment Scale (Escala de Avaliação de Atividade Diária). This categorical scale has five possible scores: 0 (no pain), 3 (pain present, with periods when it is forgotten), 6 (pain is not forgotten but does not prevent activities of daily living), 8 (pain is not forgotten and interferes with all activities of daily living except eating and personal hygiene), and 10 (pain persists even at rest and cannot be ignored; rest is imperative). Scores range from 0 to 10, with higher scores indicating a worse outcome. A negative change indicates improvement.
Time frame: Baseline to 5 months
Adverse events
Frequency and characteristics of adverse events, including serious adverse events, events considered related to the intervention, and events leading to interruption of treatment.
Time frame: From baseline through 5 months
Change in SF-36 scores
Descriptive assessment of change in quality of life from baseline to 5 months, measured with the 36-Item Short Form Health Survey (SF-36), Brazilian Portuguese validated version. Owing to logistical constraints, the SF-36 was administered only to a subsample of participants (n = 35), at baseline and monthly through 5 months. Results are reported for the eight SF-36 domains (physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), each scored from 0 to 100, with higher scores indicating better health status (for the bodily pain domain, higher scores indicate less pain). A positive change indicates improvement.
Time frame: Baseline and 5 months
Plan to share: No — There is no current plan to share individual participant-level data.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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