Chronic PainNCT07891819
Acupuncture Versus Conventional Treatment for Chronic Pain in Patients With Chronic Kidney Disease
A study testing Acupuncture and Optimized conventional pharmacological treatment in people with Chronic Pain and Neuralgia, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Neuralgia, Renal Insufficiency,Chronic
- What is being tested?
- Acupuncture and Optimized conventional pharmacological treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Sep 2023to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparative Study of the Efficacy of Acupuncture Versus Conventional Treatment for the Management of Chronic Pain in Patients With Chronic Kidney Disease Receiving Conservative Treatment or Renal Replacement Therapy (Peritoneal Dialysis or Hemodialysis)
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.
Read the detailed description
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.
- Conditions
- Chronic Pain, Neuralgia, Renal Insufficiency,Chronic
- Being tested
- Acupuncture, Optimized conventional pharmacological treatment
- Keywords
- Acupuncture, hemodialysis, Peritoneal dialysis, chronic kidney disease, pain management
- Medical subject headings
- Chronic Pain, Neuralgia, Renal Insufficiency, Chronic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Individualized acupuncture administered weekly for approximately four months, with 16 sessions planned and a minimum of 10 sessions considered necessary for efficacy evaluation.
Optimized conventional pharmacological treatmentDrug
Conventional pharmacological treatment for chronic pain in patients with chronic kidney disease, individualized according to the treating physician's clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Acupuncture; Drug: Optimized conventional pharmacological treatment |
| Conventional treatment alone | Active comparator | Optimized conventional pharmacological treatment for chronic pain, without acupuncture. Receives: Drug: Optimized conventional pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 5 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start6 Sep 2023
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Santos de Pinho, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891819
- Sponsor's protocol ID
- 69530923.8.0000.5505
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of the Efficacy of Acupuncture Versus Conventional Treatment for the Management of Chronic Pain in Patients With Chronic Kidney Disease Receiving Conservative Treatment or Renal Replacement Therapy (Peritoneal Dialysis or Hemodialysis)
- ClinicalTrials.gov ID
- NCT07891819
- Acronym / sponsor ID
- 69530923.8.0000.5505
- Conditions
- Chronic Pain, Neuralgia, Renal Insufficiency,Chronic
- Keywords
- Acupuncture, hemodialysis, Peritoneal dialysis, chronic kidney disease, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture plus conventional treatment - Experimental | Experimental | Other: Acupuncture, Drug: Optimized conventional pharmacological treatmentIndividualized 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. |
| Conventional treatment alone | Active comparator | Drug: Optimized conventional pharmacological treatmentOptimized conventional pharmacological treatment for chronic pain, without acupuncture. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureIndividualized acupuncture administered weekly for approximately four months, with 16 sessions planned and a minimum of 10 sessions considered necessary for efficacy evaluation. | Other | Acupuncture plus conventional treatment - Experimental |
| Optimized conventional pharmacological treatmentConventional pharmacological treatment for chronic pain in patients with chronic kidney disease, individualized according to the treating physician's clinical judgment. | Drug | Acupuncture plus conventional treatment - Experimental, Conventional treatment alone |
Primary outcome
Change in pain intensity from baseline to the final study visit
Time frame: Baseline and 5 months
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.
4 secondary outcomes
Proportion of participants achieving a reduction of at least 2 points in pain intensity
Time frame: Baseline and 5 months
Change in limitation of daily activities
Time frame: Baseline to 5 months
Adverse events
Time frame: From baseline through 5 months
Change in SF-36 scores
Time frame: Baseline and 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Optimized conventional pharmacological treatment in people with Chronic Pain and Neuralgia, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity from baseline to the final study visit (time frame: Baseline and 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.