An interventional study of TENS in Pain, sponsored by Foundation University Islamabad. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 57 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Supportive care
Orthodontic treatment often causes pain during the initial alignment stage which can lead to discomfort, reduced compliance, and slower treatment progress.
Potential Solution: Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive, non-pharmacological approach that uses mild electrical currents to stimulate nerves and potentially reduce pain.
This study uses a split-mouth design, with each patient acting as their own control. One side of their mouth receives the TENS therapy, while the other receives a placebo treatment (minimum current below the therapeutic level). This allows for a direct comparison of TENS effectiveness without the influence of individual pain variations.
Research Goal: The study aims to determine whether TENS can effectively manage pain during initial orthodontic treatment. This would offer a safe and natural alternative to pain medications, potentially improving patient comfort and treatment outcomes.
Goal:
This study aims to investigate the potential of Transcutaneous Electrical Nerve Stimulation (TENS) as a safe and effective non-pharmacological approach for managing pain during the initial stages of orthodontic treatment.
The study will compare the pain-relieving effect of TENS therapy with a placebo treatment in a split-mouth design. This means that each participant will act as their own control, with one side of their mouth receiving TENS and the other side receiving a placebo treatment that mimics the TENS device but delivers minimal electrical current.
The study will involve individuals aged 15-57 years old who are undergoing initial orthodontic treatment with alignment archwires. Participants should have good oral hygiene and no contraindications to TENS therapy, such as epilepsy, cardiac arrhythmias, or pacemakers.
The primary question the study aims to answer is: Can TENS be used as an effective alternative to pain medication for managing pain during the initial stages of orthodontic treatment? Participants will undergo a thorough clinical examination and provide informed consent.
Each participant's mouth will be randomly assigned to receive TENS therapy on one side and a placebo treatment on the other.
The TENS group will receive two 5-minute active TENS therapy sessions with a 2-minute break in between, using self-adhesive electrode pads placed on the designated cheek as determined by randomization.
The placebo group will receive a similar treatment that mimics the TENS application but with minimal current to maintain patient blinding.
Participants will mark their pain levels on a visual analog scale (VAS) at 0, 6, 24, and 48 hours after the treatment.
Comparison Groups and Expected Effects:
TENS Group vs. Placebo Group: The researcher will compare the pain reduction reported by the TENS group and the placebo group at the specified time intervals i.e at 0, 6, 24, and 48 hours after the treatment.
Inclusion Criteria: - both male and female patients Age 18-57 years Good oral hygiene Patients in alignment and levelling stage Patients how have not taken any pain medication in the past 24 hours
Exclusion Criteria:- Patients with history of epilepsy Patients with cardia arrhythmias and pacemaker Pregnant patients
Participants in this arm will receive two 5-minute sessions of TENS therapy with a 2-minute break in between. Self-adhesive electrode pads will be placed on the designated cheek as determined by randomization. The TENS device will be set at intensity that is comfortable for the participant. The device will deliver electrical pulses through the electrodes to stimulate sensory nerves and potentially reduce pain. Participants will receive this TENS therapy application immediately after the initial placement of the alignment archwire Both groups will be instructed to mark their pain levels on a visual analog scale (VAS) at 0, 6, 24, and 48 hours after the initial archwire placement.
Device: TENS
Participants in this arm will receive a similar treatment that mimics the TENS application but with minimal current to maintain participant blinding. Similar to the TENS group, self-adhesive electrode pads will be placed on the designated cheek. The placebo device will be set at a very low intensity that only feels like a slight tingling sensation. This sham treatment serves as a control, allowing comparison of any pain reduction to the effects of real TENS therapy.Participants will receive this placebo treatment application on the same schedule as the TENS group - immediately after archwire placement
Device: TENS
Trancutaneous electrical nerve stimulation device with self-adhesive pads will be placed on patients cheeks. Experimental side will recveive active TENS treatment and other side will receive treatment with intensity of TENS set at low intensity (subtherapeutic)
Pain will be measured after intervention at visual analogue scale
pateint after giving TENS treatment will be asked to measure their pain score for right and left side on visual analogue scale
Time frame: pain will be marked on visual analogue scale at 0 hour , 6 hours, 24 hours, 48 hours
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Foundation University Islamabad