HealthyEarly Phase 1NCT06981260
The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers
A Early Phase 1 study testing Group A Deactivated TENS with beeping sound (15-second interval) and Group B in people with Healthy, run by Institute of Health and Resilience.
Trial summary
Placebo responses are now recognized for their clinical and physiological significance. Non-pharmacological cues such as sound may enhance or induce these responses. This trial aims to assess the effect of sound on the placebo-induced hypoalgesia elicited by a deactivated TENS device in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Group A Deactivated TENS with beeping sound (15-second interval) and Group B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2016to 14 Jun 2016
- Phase
- Early Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No history of TENS use
Who cannot join
- Current medication use
- Orthopedic, neurological, or systemic conditions
- Pregnancy (current and planned)
About this study
Placebo responses are now recognized for their clinical and physiological significance. Non-pharmacological cues such as sound may enhance or induce these responses. This trial aims to assess the effect of sound on the placebo-induced hypoalgesia elicited by a deactivated TENS device in healthy individuals.
- Conditions
- Healthy
- Being tested
- Group A Deactivated TENS with beeping sound (15-second interval), Group B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A Deactivated TENS with beeping sound (15-second interval)Procedure or surgery
Deactivated TENS with beeping sound (15-second interval)
Group BProcedure or surgery
Deactivated TENS without sound
| Study group | Role | What they receive |
|---|---|---|
| Group A: Placebo with sound | Experimental | Deactivated transcutaneous electrical nerve stimulation (TENS) with beeping sound (15-second interval) Receives: Procedure: Group A Deactivated TENS with beeping sound (15-second interval) |
| Group B: Placebo with no sound | Experimental | Group B: Deactivated transcutaneous electrical nerve stimulation (TENS) without sound Receives: Procedure: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention.
Change in pain pressure threshold (PPT) at L2 (2nd lumbar vertebra) from baseline to post-intervention. Measured using pressure algometer (Wagner Force Dial FDK/FDN Series).
Measured: From Baseliine to 5 minutes
Secondary outcomes (1)
Effect of gender on placebo response
Effect of gender on placebo response (ANOVA analysis on post-treatment PPT)
Measured: From Baseliine to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start13 Jun 2016
- Primary completion14 Jun 2016
- Study completion14 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A healthy volunteer pilot study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Health and Resilience
- Sponsor type
- University, hospital or other
- Collaborators
- Aegean College, Athens, Greece, Coventry University, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981260
- Sponsor's protocol ID
- SOUNDPLACEBO-2016-001
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06981260
- Acronym / sponsor ID
- SOUNDPLACEBO-2016-001
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Institute of Health and ResilienceUniversity, hospital or other
- Collaborators
- Aegean College, Athens, Greece, Coventry University, United Kingdom
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 14 Jun 2016 (actual)
- Study completion
- 14 Jun 2016 (actual)
- First posted
- 20 May 2025 (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.
Placebo responses are now recognized for their clinical and physiological significance. Non-pharmacological cues such as sound may enhance or induce these responses. This trial aims to assess the effect of sound on the placebo-induced hypoalgesia elicited by a deactivated TENS device in healthy individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A healthy volunteer pilot study.
| Arm | Type | Receives |
|---|---|---|
| Group A: Placebo with sound | Experimental | Procedure: Group A Deactivated TENS with beeping sound (15-second interval)Deactivated transcutaneous electrical nerve stimulation (TENS) with beeping sound (15-second interval) |
| Group B: Placebo with no sound | Experimental | Procedure: Group BGroup B: Deactivated transcutaneous electrical nerve stimulation (TENS) without sound |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No history of TENS use
Key exclusion criteria (3 listed)
- Current medication use
- Orthopedic, neurological, or systemic conditions
- Pregnancy (current and planned)
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 |
|---|---|---|
| Group A Deactivated TENS with beeping sound (15-second interval)Deactivated TENS with beeping sound (15-second interval) | Procedure or surgery | Group A: Placebo with sound |
| Group BDeactivated TENS without sound | Procedure or surgery | Group B: Placebo with no sound |
Primary outcome
Change in pain pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention.
Time frame: From Baseliine to 5 minutes
Change in pain pressure threshold (PPT) at L2 (2nd lumbar vertebra) from baseline to post-intervention. Measured using pressure algometer (Wagner Force Dial FDK/FDN Series).
1 secondary outcome
Effect of gender on placebo response
Time frame: From Baseliine to 5 minutes
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 20 May 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Group A Deactivated TENS with beeping sound (15-second interval) and Group B in people with Healthy, run by Institute of Health and Resilience.
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 1 inclusion and 3 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 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention. (time frame: From Baseliine to 5 minutes). 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 20 May 2025.