An interventional study of Auricular Electroacupuncture and Auricular Acupuncture in Leprosy, sponsored by Universidade Federal de Pernambuco. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment
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.
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.
52 studies on the registry are indexed under Leprosy; 12 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 41 interventional studies indexed under Leprosy.
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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.
Procedure: Auricular Electroacupuncture · Behavioral: Health Education
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.
Procedure: Auricular Acupuncture · Behavioral: Health Education
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.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
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.
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.
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.
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.
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.
Time frame: Baseline and immediately after completion of the intervention period
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.
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
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.
Time frame: 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
Time frame: 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.
Time frame: Baseline and immediately after completion of the intervention period
Plan to share: 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.
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