LeprosyNCT07862413
Auricular Electroacupuncture and Auricular Acupuncture With Health Education for Pain in Leprosy
A study testing Auricular Electroacupuncture, Auricular Acupuncture and Health Education in people with Leprosy, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
This randomized controlled pilot study evaluated the effects of auricular electroacupuncture and auricular acupuncture combined with health education on pain management in adults diagnosed with leprosy or who had completed pharmacological treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leprosy
- What is being tested?
- Auricular Electroacupuncture, Auricular Acupuncture and Health Education
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2025to 31 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Confirmed diagnosis of leprosy, regardless of clinical form.
- Availability to participate in the study twice weekly for 5 weeks.
- Agreement to participate in the study and provision of informed consent.
Who cannot join
- Diagnosis of neurological disease, including stroke, Alzheimer's disease, Parkinson's disease, or amyotrophic lateral sclerosis.
- Use of a cardiac pacemaker.
- Diagnosis of neoplasia.
- Pregnancy.
- Participation in another physiotherapy treatment during the study period.
- Use of a hearing aid.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Electrothermophototherapy (LETER), Department of Physiotherapy, Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-901
About this study
Official title: Electroacupuncture and Auricular Acupuncture Associated With Health Education in Pain Management in Leprosy: A Randomized Controlled Pilot Study
This randomized controlled pilot study evaluated the effects of auricular electroacupuncture and auricular acupuncture combined with health education on pain management in adults diagnosed with leprosy or who had completed pharmacological treatment. Participants were randomly allocated to three parallel groups: auricular electroacupuncture plus health education, auricular acupuncture plus health education, or an active control group receiving transcutaneous electrical nerve stimulation (TENS). The primary outcome was pain intensity, assessed using the Visual Analog Scale. Secondary outcomes included functional mobility, upper limb function, physical disability, and quality of life. Assessments were performed at baseline and after the intervention period.
Read the detailed description
This was a randomized controlled pilot study with three parallel intervention groups and blinded outcome assessors. Adults with a confirmed diagnosis of leprosy, regardless of clinical form, including individuals undergoing or having completed pharmacological treatment, were eligible to participate.
Participants were randomly allocated in a 1:1:1 ratio to one of three groups. The auricular electroacupuncture group received auricular electroacupuncture combined with health education. The auricular acupuncture group received auricular acupuncture without electrical stimulation combined with the same health education intervention. The active control group received transcutaneous electrical nerve stimulation (TENS) applied to the area of greatest pain intensity.
Auricular intervention groups received 10 sessions, conducted twice weekly. Auricular procedures lasted 30 minutes per session and were followed by approximately 10 minutes of health education. The active control group received TENS twice weekly for four weeks, totaling 8 sessions, with each session lasting 30 minutes.
Pain intensity was the primary outcome and was assessed using the Visual Analog Scale. Secondary outcomes included functional mobility assessed by the Timed Up and Go test, upper limb function assessed by the Disabilities of the Arm, Shoulder and Hand Questionnaire, physical disability and neural function assessed through the Simplified Neurological Assessment and Eye-Hand-Foot score, and quality of life assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey.
Outcome assessments were performed before the intervention and after completion of the treatment period.
- Conditions
- Leprosy
- Being tested
- Auricular Electroacupuncture, Auricular Acupuncture, Health Education, Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Leprosy, Auricular Electroacupuncture, Auricular Acupuncture, Health Education, Pain, Transcutaneous Electrical Nerve Stimulation, Quality of Life
- Medical subject headings
- Leprosy, Health Education, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular ElectroacupunctureProcedure or surgery
Participants received 10 sessions of auricular electroacupuncture, twice weekly for 5 weeks. Sterile filiform acupuncture needles (0.25 mm × 30 mm) were inserted at predefined auricular points. Electrical stimulation was delivered using a continuous pulse at 2 Hz, pulse width of 0.5 ms, and intensity adjusted to the participant's maximum tolerance. Each electroacupuncture session lasted 30 minutes.
Auricular AcupunctureProcedure or surgery
Participants received 10 sessions of auricular acupuncture, twice weekly for 5 weeks. Sterile filiform acupuncture needles were inserted at the same predefined auricular points used in the auricular electroacupuncture group. Electrodes were connected to the needles, but no electrical stimulation was delivered. Each auricular acupuncture session lasted 30 minutes.
Health EducationBehavioural
Participants received approximately 10 minutes of health education during each treatment session. The intervention was based on pain neuroscience education and addressed leprosy, pain mechanisms, self-care, treatment, and strategies to promote autonomy and active participation in health care. Educational activities used accessible language and included interactive and educational resources adapted to participants' level of understanding.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Participants received conventional transcutaneous electrical nerve stimulation (TENS) applied to the area of greatest pain intensity. Stimulation was delivered using a biphasic, rectangular, symmetrical, balanced waveform at 100 Hz, with a pulse width of 100 µs. Each session lasted 30 minutes. Treatment was administered twice weekly for 4 weeks, totaling 8 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Electroacupuncture Plus Health Education | Experimental | Participants received 10 sessions of auricular electroacupuncture, twice weekly for 5 weeks. Each session included 30 minutes of auricular electroacupuncture followed by approximately 10 minutes of health education. Receives: Procedure: Auricular Electroacupuncture; Behavioral: Health Education |
| Auricular Acupuncture Plus Health Education | Experimental | Participants received 10 sessions of auricular acupuncture without active electrical stimulation, twice weekly for 5 weeks. Each session included 30 minutes of auricular acupuncture followed by approximately 10 minutes of health education. Receives: Procedure: Auricular Acupuncture; Behavioral: Health Education |
| Transcutaneous Electrical Nerve Stimulation | Experimental | Participants received conventional transcutaneous electrical nerve stimulation (TENS) applied to the area of greatest pain intensity, twice weekly for 4 weeks, totaling 8 sessions of 30 minutes each. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Assessed by the Visual Analog Scale
Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Measured: Baseline and immediately after completion of the intervention period
Secondary outcomes (4)
Functional Mobility Assessed by the Timed Up and Go Test
Functional mobility was assessed using the Timed Up and Go (TUG) test, which measures the time, in seconds, required for the participant to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down. Lower times indicate better functional mobility.
Measured: Baseline and immediately after completion of the intervention period
Upper Limb Function Assessed by the Disabilities of the Arm, Shoulder and Hand Questionnaire
Upper limb function was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. The total score ranges from 0 to 100, with higher scores indicating greater disability and poorer upper limb function.
Measured: Baseline and immediately after completion of the intervention period
Physical Disability Assessed by the Eye-Hand-Foot Score
Physical disability related to leprosy was assessed using the Eye-Hand-Foot (EHF) score derived from the Simplified Neurological Assessment. The total score ranges from 0 to 12, with higher scores indicating greater physical disability
Measured: Baseline and immediately after completion of the intervention period
Quality of Life Assessed by the 36-Item Short Form Health Survey
Quality of life was assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), comprising eight 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 domain is scored from 0 to 100, with higher scores indicating better perceived health-related quality of life.
Measured: Baseline and immediately after completion of the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Apr 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to three parallel intervention groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Felipe da Silva Souza, Universidade Federal de Pernambuco
- Investigators
- Marcelo R Guerino, PhD, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862413
- Sponsor's protocol ID
- 84818024.7.0000.5208
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no formal plan to share individual participant data (IPD) with other researchers. Study results will be disseminated in aggregate form through scientific publications and academic presentations.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture and Auricular Acupuncture Associated With Health Education in Pain Management in Leprosy: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07862413
- Acronym / sponsor ID
- 84818024.7.0000.5208
- Conditions
- Leprosy
- Keywords
- Leprosy, Auricular Electroacupuncture, Auricular Acupuncture, Health Education, Pain, Transcutaneous Electrical Nerve Stimulation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 7 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 randomized controlled pilot study evaluated the effects of auricular electroacupuncture and auricular acupuncture combined with health education on pain management in adults diagnosed with leprosy or who had completed pharmacological treatment. Participants were randomly allocated to three parallel groups: auricular electroacupuncture plus health education, auricular acupuncture plus health education, or an active control group receiving transcutaneous electrical nerve stimulation (TENS). The primary outcome was pain intensity, assessed using the Visual Analog Scale. Secondary outcomes included functional mobility, upper limb function, physical disability, and quality of life. Assessments were performed at baseline and after the intervention period.
Detailed description
This was a randomized controlled pilot study with three parallel intervention groups and blinded outcome assessors. Adults with a confirmed diagnosis of leprosy, regardless of clinical form, including individuals undergoing or having completed pharmacological treatment, were eligible to participate.
Participants were randomly allocated in a 1:1:1 ratio to one of three groups. The auricular electroacupuncture group received auricular electroacupuncture combined with health education. The auricular acupuncture group received auricular acupuncture without electrical stimulation combined with the same health education intervention. The active control group received transcutaneous electrical nerve stimulation (TENS) applied to the area of greatest pain intensity.
Auricular intervention groups received 10 sessions, conducted twice weekly. Auricular procedures lasted 30 minutes per session and were followed by approximately 10 minutes of health education. The active control group received TENS twice weekly for four weeks, totaling 8 sessions, with each session lasting 30 minutes.
Pain intensity was the primary outcome and was assessed using the Visual Analog Scale. Secondary outcomes included functional mobility assessed by the Timed Up and Go test, upper limb function assessed by the Disabilities of the Arm, Shoulder and Hand Questionnaire, physical disability and neural function assessed through the Simplified Neurological Assessment and Eye-Hand-Foot score, and quality of life assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey.
Outcome assessments were performed before the intervention and after completion of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to three parallel intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Auricular Electroacupuncture Plus Health Education | Experimental | Procedure: Auricular Electroacupuncture, Behavioral: Health EducationParticipants received 10 sessions of auricular electroacupuncture, twice weekly for 5 weeks. Each session included 30 minutes of auricular electroacupuncture followed by approximately 10 minutes of health education. |
| Auricular Acupuncture Plus Health Education | Experimental | Procedure: Auricular Acupuncture, Behavioral: Health EducationParticipants received 10 sessions of auricular acupuncture without active electrical stimulation, twice weekly for 5 weeks. Each session included 30 minutes of auricular acupuncture followed by approximately 10 minutes of health education. |
| Transcutaneous Electrical Nerve Stimulation | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants received conventional transcutaneous electrical nerve stimulation (TENS) applied to the area of greatest pain intensity, twice weekly for 4 weeks, totaling 8 sessions of 30 minutes each. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Confirmed diagnosis of leprosy, regardless of clinical form.
- Availability to participate in the study twice weekly for 5 weeks.
- Agreement to participate in the study and provision of informed consent.
Key exclusion criteria (6 listed)
- Diagnosis of neurological disease, including stroke, Alzheimer's disease, Parkinson's disease, or amyotrophic lateral sclerosis.
- Use of a cardiac pacemaker.
- Diagnosis of neoplasia.
- Pregnancy.
- Participation in another physiotherapy treatment during the study period.
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 |
|---|---|---|
| Auricular ElectroacupunctureParticipants received 10 sessions of auricular electroacupuncture, twice weekly for 5 weeks. Sterile filiform acupuncture needles (0.25 mm × 30 mm) were inserted at predefined auricular points. Electrical stimulation was delivered using a continuous pulse at 2 Hz, pulse width of 0.5 ms, and intensity adjusted to the participant's maximum tolerance. Each electroacupuncture session lasted 30 minutes. | Procedure or surgery | Auricular Electroacupuncture Plus Health Education |
| Auricular AcupunctureParticipants received 10 sessions of auricular acupuncture, twice weekly for 5 weeks. Sterile filiform acupuncture needles were inserted at the same predefined auricular points used in the auricular electroacupuncture group. Electrodes were connected to the needles, but no electrical stimulation was delivered. Each auricular acupuncture session lasted 30 minutes. | Procedure or surgery | Auricular Acupuncture Plus Health Education |
| Health EducationParticipants received approximately 10 minutes of health education during each treatment session. The intervention was based on pain neuroscience education and addressed leprosy, pain mechanisms, self-care, treatment, and strategies to promote autonomy and active participation in health care. Educational activities used accessible language and included interactive and educational resources adapted to participants' level of understanding. | Behavioural | Auricular Acupuncture Plus Health Education, Auricular Electroacupuncture Plus Health Education |
| Transcutaneous Electrical Nerve Stimulation (TENS)Participants received conventional transcutaneous electrical nerve stimulation (TENS) applied to the area of greatest pain intensity. Stimulation was delivered using a biphasic, rectangular, symmetrical, balanced waveform at 100 Hz, with a pulse width of 100 µs. Each session lasted 30 minutes. Treatment was administered twice weekly for 4 weeks, totaling 8 sessions. | Device | Transcutaneous Electrical Nerve Stimulation |
Primary outcome
Pain Intensity Assessed by the Visual Analog Scale
Time frame: Baseline and immediately after completion of the intervention period
Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
4 secondary outcomes
Functional Mobility Assessed by the Timed Up and Go Test
Time frame: Baseline and immediately after completion of the intervention period
Upper Limb Function Assessed by the Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: Baseline and immediately after completion of the intervention period
Physical Disability Assessed by the Eye-Hand-Foot Score
Time frame: Baseline and immediately after completion of the intervention period
Quality of Life Assessed by the 36-Item Short Form Health Survey
Time frame: Baseline and immediately after completion of the intervention period
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 7 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no formal plan to share individual participant data (IPD) with other researchers. Study results will be disseminated in aggregate form through scientific publications and academic presentations.
Related trials for Leprosy
Not yet recruitingPhase 2
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Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
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RecruitingObservational study
Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
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RecruitingPhase 3
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
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Recruiting
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
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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.
Marcelo R Guerino, PhD principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Electroacupuncture, Auricular Acupuncture and Health Education in people with Leprosy, run by Universidade Federal de Pernambuco 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 4 inclusion and 6 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 7 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?
Pain Intensity Assessed by the Visual Analog Scale (time frame: Baseline and immediately after completion of the intervention period). 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 7 Oct 2026.