Acupuncture Versus Conventional Treatment for Chronic Pain in Patients With Chronic Kidney Disease

NCT07891819 | Completed

• 1 other identifier: 69530923.8.0000.5505
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Neuralgia; Renal Insufficiency,Chronic

Keywords

Acupuncture; hemodialysis; Peritoneal dialysis; chronic kidney disease; pain management

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 5 months

Secondary Outcomes (4)

• Proportion of participants achieving a reduction of at least 2 points in pain intensity

  Baseline and 5 months

• Change in limitation of daily activities

  Baseline to 5 months

• Adverse events

  From baseline through 5 months

• Change in SF-36 scores

  Baseline and 5 months

Study Arms (2)

Acupuncture plus conventional treatment - Experimental

EXPERIMENTAL

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

Conventional treatment alone

ACTIVE COMPARATOR

Optimized conventional pharmacological treatment for chronic pain, without acupuncture.

Drug: Optimized conventional pharmacological treatment

Interventions

Acupuncture OTHER

Individualized acupuncture administered weekly for approximately four months, with 16 sessions planned and a minimum of 10 sessions considered necessary for efficacy evaluation.

Acupuncture plus conventional treatment - Experimental

Optimized conventional pharmacological treatment DRUG

Conventional pharmacological treatment for chronic pain in patients with chronic kidney disease, individualized according to the treating physician's clinical judgment.

Acupuncture plus conventional treatment - Experimental; Conventional treatment alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 75 years, of either sex
• Chronic pain lasting more than 3 months
• Pain intensity of at least 6 on a 0-to-10 visual analog scale (VAS) at the allocation visit (V2)
• Chronic kidney disease managed with conservative treatment or receiving renal replacement therapy with peritoneal dialysis or hemodialysis
• Signed informed consent

You may not qualify if:

• Pregnancy
• Inability to understand study instructions, attend study visits, or complete the assessment scales
• History of alcohol or drug abuse
• Psychological or emotional disorders considered likely to invalidate informed consent or limit adherence to study procedures
• Coagulation disorders
• Allergy to commonly used analgesic medications
• Recommendation to discontinue nonsteroidal anti-inflammatory drugs (NSAIDs)

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital do Rim

São Paulo, São Paulo, 05078-000, Brazil

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Renal Insufficiency, Chronic; Agnosia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The study was open-label. Participants and study personnel were aware of the treatment received. No masking was used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The protocol planned simple 1:1 randomization using a computer-generated random sequence. Participants who expressed a preference for acupuncture before allocation and refused the possibility of receiving conventional pharmacological treatment alone were assigned to the acupuncture group regardless of the planned sequence. Participants without an expressed preference were allocated using the planned random sequence. Actual allocation was therefore not exclusively randomized.

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 23, 2026
• Study Start: September 6, 2023
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)