PainTENSNCT07760337
A Split Mouth Study to Evaluate Transcutaneous Electrical Nerve Stimulation as an Effective Non-pharmacological Approach in Managing Pain During Initial Orthodontic Treatment - A Randomized Controlled Trial
A study testing TENS in people with Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2024to 2 Dec 2024
- 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 57 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- TENS
- Keywords
- Transcutaneous electrical nerve stimulation, Pain, orthodontic wire
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| TENS group | Experimental | 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. Receives: Device: TENS |
| Placebo/Control group | Sham comparator | 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 Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pain will be marked on visual analogue scale at 0 hour , 6 hours, 24 hours, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start20 Mar 2024
- Primary completion2 Oct 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Model: Parallel-Arm Design Model Description: This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive TENS therapy or a placebo treatment. They will remain in their assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760337
- Sponsor's protocol ID
- FUCDCLINIC-2401
- Acronym
- TENS
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split Mouth Study to Evaluate Transcutaneous Electrical Nerve Stimulation as an Effective Non-pharmacological Approach in Managing Pain During Initial Orthodontic Treatment - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07760337
- Acronym / sponsor ID
- TENS / FUCDCLINIC-2401
- Conditions
- Pain
- Keywords
- Transcutaneous electrical nerve stimulation, Pain, orthodontic wire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 12 Aug 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model: Parallel-Arm Design Model Description: This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive TENS therapy or a placebo treatment. They will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Device: TENSParticipants 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. |
| Placebo/Control group | Sham comparator | Device: TENSParticipants 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 |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| TENSTrancutaneous 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) | Device | Placebo/Control group, TENS group |
Primary outcome
Pain will be measured after intervention at visual analogue scale
Time frame: pain will be marked on visual analogue scale at 0 hour , 6 hours, 24 hours, 48 hours
pateint after giving TENS treatment will be asked to measure their pain score for right and left side on visual analogue scale
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 12 Aug 2026.
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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 TENS in people with Pain, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Aug 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 Pakistan. 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. Some participants in this study may receive a placebo. 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 will be measured after intervention at visual analogue scale (time frame: pain will be marked on visual analogue scale at 0 hour , 6 hours, 24 hours, 48 hours). 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 12 Aug 2026.