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OpenTrials
Completed

NCT Number: NCT06981260

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No history of TENS use

Exclusion criteria

  • Current medication use
  • Orthopedic, neurological, or systemic conditions
  • Pregnancy (current and planned)

Treatment and study plan

Group A Deactivated TENS with beeping sound (15-second interval)

Procedure

Deactivated TENS with beeping sound (15-second interval)

Group B

Procedure

Deactivated TENS without sound

Primary outcomes

  1. 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).

Secondary outcomes

  1. Effect of gender on placebo response

    Time frame: From Baseliine to 5 minutes

    Effect of gender on placebo response (ANOVA analysis on post-treatment PPT)

Sponsors and collaborators

Lead sponsor

Institute of Health and Resilience

Other

Collaborators

  • Aegean College, Athens, Greece
  • Coventry University, United Kingdom

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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